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Applied Biosystems 9800 FAST Thermal Cycler

1. Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 54 of 84 Applied Biosystems 10 3 Operation Qualification continued Input Expected Output Acceptable Initials Date Yes No For 96 well and 60 well Display output Yes No O systems using the keypad enter 25 then press the Start soft key Please wait Cover is heating For 384 well systems using the keypad enter 10 then press the Start soft key Current temperature XXX C The run will begin when the heated cover reaches 103 C Cancel Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Applied Biosystems Part Number IQ OQ Data Sheets Revision Page 4374845 C 55 of 84 Input Press the STOP keypad button when the run begins Press the Resume soft key Press the STOP keypad button two times in succession Press the Exit soft key Press the Run and View soft keys in succession Acceptable Yes No Yes No O Expected Output Display output Sample XX X Confirm Stop HOT Confirm Stop Press STOP to abort Press Resume to continue Resume Display output Example Only Sample 56 7
2. X XX 3 min Timer Press Enter after entering actual Display output for 96 well and 60 well systems Yes LI No block temperature Calibration Verification Block temp XX X C Cover temp XXX C Enter actual block temperature 00 0 Cancel The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 43 of 84 Applied Biosystems 10 3 Operation Qualification continued Input Expected Output Acceptable Initials Date Yes No Display output Yes L No L Calibration Verification Block temp XX X C Cover temp XXX C Set point is 45 C Cover must be within 30 C of 45 C Cancel Display Output Calibration Verification Block temp XX X C Cover temp XX C Stabilizing at set point X XX C 3 min Timer Cancel Press Enter after entering block Display output temperature on the keypad Calibration Verification Block temp 45 0 C Cover temp XX C Enter actual block temperature 00 0 Cancel Press Accept Display output Calibration Verification Actual temperature at 85 C XXX Actual temperature at 45 C XXX Accept Cancel If calibration is good press Display output Yes No O Exit Calibration Verification Open the Heated cover Lid Calibration is good Remove the probe Exit The AB Design and this sentence must be BLUE in color Part Number 4374845 Bob ne IQ OQ Data Sh
3. XX XX XX XXXX XXX XX XX XX XX Edit View User Sort Cancel Press the Sort soft key Display output Sort Methods By Method Date last used Date stored Method size With the Circular key highlight Display output sorted by Method size Yes L No Method size and press Accept Methods User Size Last Used soft key XXXX XXX XX XX XX XX XXXX XXX XX XX XX XX Edit View User Sort Cancel Alternate Screen Free Mem XX methods XXX segments XXXX XXX XX XX XX XX XXXX XXX XX XX XX XX Edit View User Sort Cancel The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 62 of 84 Applied Biosystems 10 3 Operation Qualification continued Input Expected Output Acceptable Initials Date Yes No Press the Cancel soft key Display output Yes No O Time Date Temp C Applied Biosystems 9800 System Version XXX Name XXXXX User lt lt ab gt gt Run Create Edit Util User Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 63 of 84 Applied Biosystems Input Expected Output Acceptable Initials Date Yes No Press the Edit soft key two times Display output Yes No
4. Biosystems 10 3 Operation Qualification continued Input Expected Output Acceptable Initials Date Yes No Press the Lock soft key Display output Yes No O User name test PIN number XXX Protection Locked Press PIN to create a Then you set protection to Locked to prevent methods from being over written or deleted Accept Name PIN Unlock Cancel Press the Unlock soft key Display output User name test1 PIN number XXX Protection Unlocked Press PIN to create a Then you set protection to Locked to prevent methods from being over written or deleted Accept Name PIN Lock Cancel Press the Lock soft key Display output Yes LI No User name test1 PIN number XXX Protection Locked Press PIN to create a Then you set protection to Locked to prevent methods from being over written or deleted Accept Name PIN Unlock Cancel Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Applied Biosystems IQ OQ Data Sheets Part Number 4374845 Revision C Page 50 of 84 10 3 Operation Qualification continued Input Expected Output Press the Accept soft key Display output Select User Name lt lt ab gt gt XXX testl Accept New Edit Delete Cancel Press the Acce
5. Display output HOT may be blinking in display Yes No O 10 seconds for screen to return Test thermal cycler program running automatically Pause Info Press the Pause soft key Display output HOT may be blinking in display Test thermal cycler program running Resume Paused Will resume in X XX Press the Resume soft key Display output HOT may be blinking in display Test thermal cycler program running Pause Info Let thermal cycler test program Display output Yes L No finish cycle Cycle Performance Pass Average Cycle Time XXX X sec Cycle Time STD X X sec Print Cancel Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 41 of 84 Applied Biosystems 10 3 Operation Qualification continued Input Expected Output Acceptable Initials Date Yes No Press the Cancel soft key Display output System Performance Rate Cool and Heat Rate Test Cycle Cycle Performance Test Rate Cycle Exit Press the Exit soft key Display output Diagnostics Hard Hardware Diagnostics System System Performance Tests TmpVer Temperature Verification Upgrad Firmware Upgrade Hard System TmpVer Upgrad Exit Ifa
6. C 33 of 84 10 3 Operation Qualification continued Input Expected Output Acceptable Yes No Press the Cancel soft key Display output Utilities Diag Instrument diagnostics TmCalc Calculates melting temp Config Instrument configuration Diag TmCalc Config More Exit Press the Diag soft key Display output Diagnostics Hard Hardware Diagnostics System System Performance Tests TmpVer Temperature Verification Upgrad Firmware Upgrade Hard System TmpVer Upgrad Exit Hardware Testing Display output Yes L No LJ Press the Hard soft key Hardware Diagnostics Disp LCD Display Diagnostic Keypad Keypad Diagnostic Disp Keypad Exit Initials Date Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 34 of 84 Applied Biosystems 10 3 Operation Qualification continued Input Expected Output Acceptable Initials Date Yes No Press the Disp soft key Display output Display Diagnostics Read all instructions first Press Run to turn ON all pixels Press STOP to turn OFF all pixels Press STOP to exit Press the Run soft key Display output Yes LI No All pixels ON Press
7. Date V Visually verified D Documentation reviewed and visually verified T Tested and deemed acceptable All verifications are reviewed and visually verified by the individual who signs the Conducted By Signature line above The AB Design and this sentence must be BLUE in color Part Number 4374845 AR Aa IQ OQ Protocol Revision C Page 15 of 84 9 5 Utility Description Verification Perform and document the verification activities listed below Activity 9 5 1 Verify that the laboratory meets the Laboratory Space and Layout Requirements as specified in the Applied Biosystems 9800 Fast Thermal Cycler With 96 Well Aluminum Sample Block Module Users Guide Page number 9 5 2 Verify that the that the laboratory meets the Chemical Safety Guidelines as specified in the Applied Biosystems 9800 Fast Thermal Cycler With 96 Well Aluminum Sample Block Module Users Guide Page number Insert supporting documentation in the envelope at the back of this IQ OQ Protocol binder 9 5 3 Verify that the laboratory meets the Ventilation Requirements as specified in the Applied Biosystems 9800 Fast Thermal Cycler With 96 Well Aluminum Sample Block Module Users Guide Page number Insert supporting documentation in the envelope at the back of this IQ OQ Protocol binder 9 5 4 Verify that the laboratory meets the Electrical Requirements as specified in the Applied Biosy
8. IQ OQ Data Sheets Revision C Page 78 of 84 Applied Biosystems 10 3 Operation Qualification continued Input Expected Output Acceptable Initials Date Yes No Press the Exit soft key Display output Yes No O Time Date Temp C Applied Biosystems 9800 System Version XXX User xx Run Create Edit Util User Press the User soft key use the Display output Circular Key to select lt lt ab gt gt Time Date Temp C name and press Accept soft key Applied Biosystems 9800 System Version X XX User lt lt ab gt gt Run Create Edit Util User Press the Run soft key highlight Display output HOT may be blinking AmpliTaq Gold method with the Circular Key and press the Start soft key two times in succession Sample XXX Thermal cycler test program running Pause Info Disconnect the power cord from Display output Yes No U the power source or turn the Screen goes blank and power light goes OFF instrument OFF Time OFF Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 79 of 84 Applied Biosystems 10 3 Operation Qualification continued Input Expected Output Acceptable Initials Date Yes No R
9. TmCalc Calculates melting temp Config Instrument configuration Diag TmCalc Config More Exit The AB Design and this sentence must be BLUE in color Part Number IQ OQ Data Sheets Revision Applied Biosystems Page 10 3 Operation Qualification continued Press the Config soft key Display output THEN Instrument Configuration IF the daytime is in the AM press the PM soft key if not do not press the PM soft key Date XX XX 00 M D Y Time XX XX PM Run Time Printer Off Run Time Beep Off Accept AM 24 Hr More Cancel Press the circular key in Pressing the circular key in up down side s mode up down side s mode to verify highlights the following time display date display the LCD screen can highlight month date year Off run time printer amp Off run time the following time display date beep display month date year Off run time printer amp Off run time beep Press the circular key to highlight month in the date display Display output Instrument Configuration Time XX XX PM Date XX XX XX M D Y Run Time Printer Off Run Time Beep Off Accept D M Y Y M D More Cancel 4374845 C 26 of 84 Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in colo
10. Consumable tray is installed Display output Yes LI No in the instrument open the lid and remove it Diagnostics Hard Hardware Diagnostics System System Performance Tests TmpVer Temperature Verification Upgrad Firmware Upgrade Hard System TmpVer Upgrad Exit Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 42 of 84 Applied Biosystems 10 3 Operation Qualification continued Input Expected Output Acceptable Initials Date Yes No Temperature Verification Yes L No Press the TmpVer soft key Display output Temperature Verification Temp Calibration Verification TNU Temperature Non Uniformity Temp TNU Exit Press the Temp soft key Display output Calibration Verification Place probe in well A6 Block temp XX X C Cover temp XXX C Close the Heated cover Lid Place Probe in Well A6 Press run Press Run Run Cancel Display Output Calibration Verification Block temp XX X C Cover temp XXX C Set point is 85C Cover must be within 10 C of 85 C Cancel Display Output Calibration Verification Block temp XX X C Cover temp XX C Stabilizing at set point
11. Date Yes No Press the User soft key Display output Yes No O Select User Name lt lt ab gt gt XXX test test2 test3 Accept New Edit Delete Cancel Use the Circular Key to select Display output test name and press Accept soft key Time Date Temp C Applied Biosystems 9800 System Version X XX User test1 Run Create Edit Util User Press User then Delete soft keys Display output Yes No O Select User Name lt lt ab gt gt XXX test2 test3 Accept New Edit Delete Cancel Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 73 of 84 Applied Biosystems 10 3 Operation Qualification continued Input Expected Output Acceptable Initials Date Yes No Press the Cancel soft key Display output Yes No O Time Date Temp C Applied Biosystems 9800 System Version XXX User xx Run Create Edit Util User Press the User soft key Display output Select User Name lt lt ab gt gt XXXX test2 test3 Accept New Edit Delete Cancel Use the Circular Key to select Display output Yes No O test2 name and press Accept Time Date Temp C soft key i Applied Biosystems 9800 System Version X XX User test2 Run Cr
12. No indicates the method is running Sample 56 7 Cycle 1 of 25 94 0 94 0 72 0 72 0 Initials Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 67 of 84 Applied Biosystems 10 3 Operation Qualification continued Let the Method run for Display output Temp may be blinking Yes L No approximately 5 minutes XX XX XM End of Run XX X C Press the Stop Key twice and Method XX Abort the run Run completed at XX XX XX XM XX XX XX Length of run is XX XX XX Hist Store Exit Press the Hist soft key Display output History of method XXX User XX Reaction volume XuL Run started at XX XX XX XM XX XX XX Run ended at XX XX XX XM XX XX XX Run Length XX XX XX Ramp speed 9600 No exceptions Print Return Press the Return Exit and Exit Display output Yes No O soft keys in succession Time Date Temp C Applied Biosystems 9800 System Version X XX User xx Run Create Edit Util User Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 68 of 84 Applied Biosystems 10 3 Operation Qualification continued Input Expected Output Accep
13. Protocol was completed without exceptions The Applied Biosystems 9800 FAST Thermal Cycler Instrument Performance Verification Protocol was completed with exceptions noted in the following section numbers Section numbers Final Approval Print Name Protocol Executed By Signature Title Date Print Name Results Confirmed By Signature Title Date Print Name Customer Signature Title Date Print Name Customer Signature Title Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Report Approval Revision C Page 83 of 84 Applied Biosystems This page is intentionally blank The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Report Approval Revision C Page 84 of 84 Applied Biosystems This page is intentionally blank The AB Design and this sentence must be BLUE in color
14. reviewed and visually verified T Tested and deemed acceptable All verifications are reviewed and visually verified by the individual who signs the Conducted By Signature line above The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Protocol Revision C Page 17 of 84 Applied Biosystems 9 7 Emissions and Immunity Compliance Verification Perform and document the verification activities listed below Activity Method 9 7 1 The customer signature below verifies that the owner user has read the Safety and Electromagnetic Compatibility EMC standards section of the Applied Biosystems 9800 Fast Thermal Cycler With 96 Well Aluminum Sample Block Module Users Guide Page number Exceptions Comments Acceptance Criteria All of the above requirements have been met Conducted By Signature Date Customer Signature Date V Visually verified D Documentation reviewed and visually verified T Tested and deemed acceptable All verifications are reviewed and visually verified by the individual who signs the Conducted By Signature line above The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Protocol Revision C Page 18 of 84 amp Applied Biosystems 9 8 Laboratory Environmental Operating Conditions Verification Confirm and document the verification requirements listed bel
15. the Stop soft key Display output Yes L No All pixels OFF Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 35 of 84 Applied Biosystems 10 3 Operation Qualification continued Input Expected Output Acceptable Initials Date Yes No Press the Stop soft key Display output Hardware Diagnostics Disp LCD Display Diagnostic Keypad Keypad Diagnostic Disp Keypad Press the Keypad soft key Display output Keypad Diagnostic After pressing Run press the blinking key or press STOP twice to exit Run Exit Press the Run soft key Display output F1 blinking F1 F2 F3 F4 F5 STOP L 23 456 789 ENTER 0 CE Press the indicated blinking Display output Yes LI No keypad button one time until all FI F2F3FA4FS5 blinking keys are lit on the display STOP EOS A 456 Z S ARSY v ENTER 0 CE Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 36 of 84 Applied Biosystems 10 3 Operation Qual
16. 0 FAST Thermal Cycler as configured and installed according to Applied Biosystems specifications This IQ OQ Protocol does not apply to any other products processes or optional components unless specifically stated in this document and is not to be used in conjunction with any other products or processes 4 3 This IQ OQ Protocol does not address any owner specific analytical protocol Performance Qualification or method validation Development and execution of a performance qualification protocol for the Applied Biosystems 9800 FAST Thermal Cycler is the responsibility of the instrument owner 4 4 Applied Biosystems makes no representation whatsoever that this IQ OQ Protocol satisfies or will satisfy any requirements of any governmental body or other organization including but not limited to any requirement of the United States Food and Drug Administration FDA or the International Organization for Standardization ISO The instrument owner agrees that the instrument owner is responsible to verify that this IQ OQ Protocol or this IQ OQ service is adequate to meet its regulatory and certification requirements and that all requirements of any governmental body or other organization including but not limited to any requirement of the U S Food and Drug Administration or the International Organization for Standardization are the responsibility of the instrument owner 5 Responsibilities 5 1 Applied Biosystems developed this IQ OQ Protoco
17. 2 Introduction 2 1 This IQ OQ Protocol is used to verify e The initial installation and operation of an Applied Biosystems 9800 FAST Thermal Cycler e A pre verified Applied Biosystems 9800 FAST Thermal Cycler that has been reinstalled or moved to a new location This protocol is designed to be followed in sequence from beginning to end 2 2 Successful completion of this IQ OQ Protocol verifies the Applied Biosystems 9800 FAST Thermal Cycler is at the time of testing installed and operating in accordance with Applied Biosystems specifications with any exceptions noted 2 3 Any exception conditions that occur during the performance of this IQ OQ Protocol shall be identified for review Exception conditions will be investigated and the appropriate course of action determined The operator identified by the owner of the instrument will be responsible for the successful execution and completion of the IQ OQ Protocol 2 4 To verify an Applied Biosystems 9800 FAST Thermal Cycler that has previously been verified using an Applied Biosystems IQ OQ Protocol but has subsequently undergone service repair or maintenance that 1s critical to the performance of the Applied Biosystems 9800 FAST Thermal Cycler or has site requirements for a scheduled operation qualification use an Applied Biosystems 9800 FAST Thermal Cycler Instrument Performance Verification Protocol ordered separately from Applied Biosystems instead of this IQ OQ Protocol Se
18. 3 No PIN Applied Biosystems 9800 System and one stored program Press T the User soft key and highlight Version X XX testl User testl Press Accept soft key Create Press the Run amp Start soft keys Display output Yes Nol in succession Select Method Options Reaction volume 30 uL Ramp speed HS96 or Std Run ID 1 Enter a value from 5 to 30 uL Start Cancel Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 53 of 84 Applied Biosystems 10 3 Operation Qualification continued Input Expected Output Acceptable Initials Date Yes No Using the keypad enter 31 then Display output Yes No O press the Start soft key Select Method Options Reaction volume 31 uL Ramp speed HS96 or Std Run ID 1 Enter a value from 5 to 30 uL Valid range is 5 to 30 Using the keypad enter 4 then Display output Yes No O press the Start soft key Select Method Options Reaction volume 4 uL Ramp speed HS96 or Std Run ID 1 Enter a value from 5 to 30 uL Valid range is 5 to 30 Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date
19. 3 Run Create Edit Util User Press Util More Delete soft keys Display output Yes No O in succession Methods User Size Stored XXXX test3 X XX XX XX Delete View User Sort Cancel Alternate Screen Free Mem XX methods XXX segments XXXX test3 X XX XX XX Delete View User Sort Cancel Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 77 of 84 Applied Biosystems 10 3 Operation Qualification continued Input Expected Output Acceptable Initials Date Yes No Press the Delete soft key Display output Yes No O Delete Method Methods User Size Stored XXX test3 X XX XX XX Press Yes to delete the method Yes Press the Yes soft key Display output No Methods User Cancel Press the Cancel soft key Display output Yes L No Utilities Delete Delete a method Copy Copy methods from to PC card Hist Display history of last run Delete Copy Hist More Exit Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845
20. Applied Biosystems 9800 FAST Thermal Cycler Installation Qualification and Operation Qualification Protocol Instrument Serial Numbers Base Module Sample Block Module Protocol Execution Date Applied Bibsystems 2006 Applied Biosystems All rights reserved Information in this Installation Qualification Operation Qualification Protocol IQ OQ Protocol for the Applied Biosystems 9800 Fast Thermal Cycler is subject to change without notice No changes will be made to this IQ OQ Protocol during its execution without the consent of Applied Biosystems AB and the customer AB assumes no responsibility for any errors that may appear in this document Applied Biosystems is a registered trademark of Applera Corporation or its subsidiaries in the U S and or certain other countries AB Design and Applera are trademarks of Applera Corporation or its subsidiaries in the U S and or certain other countries Microsoft and Windows are registered trademarks of Microsoft Corporation THIS DOCUMENT IS PROVIDED AS IS APPLIED BIOSYSTEMS DISCLAIMS ALL WARRANTIES WITH RESPECT TO THESE INSTALLATION QUALIFICATION AND OPERATION QUALIFICATION SERVICES AND THIS IQ OQ PROTOCOL EXPRESSED OR IMPLIED INCLUDING BUT NOT LIMITED TO THOSE OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE IN NO EVENT SHALL APPLIED BIOSYSTEMS BE LIABLE WHETHER IN CONTRACT TORT WARRANTY OR UNDER ANY STATUTE OR ON ANY OTHER BASIS FOR SPECIAL
21. BLUE in color Part Number IQ OQ Data Sheets Revision Applied Biosystems Page 4374845 C 39 of 84 10 3 Operation Qualification continued Input Expected Output Acceptable Yes No Press the Cancel soft key Display output System Performance Rate Cool and Heat Rate Test Cycle Cycle Performance Test Rate Cycle Exit Press the Cycle soft key Display output WARNING Install the appropriate empty Consumables into the Sample Block Refer to System Performance Section of Block User Manual Cancel Press Cont soft key Display output HOT may be blinking in display Test thermal cycler program running Pause Info Press the Info soft key Display output Yes No LJ XX XX XM Information XX XC User lt lt ab gt gt Method Cycle Test Run Started at XX XX XX XM XX XX XX Run will end at XX XX XX XM XX XX XX Reaction vol X uL Ramp speed HS96 Alternate STD Return Initials Date Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 40 of 84 Applied Biosystems 10 3 Operation Qualification continued Input Expected Output Acceptable Initials Date Yes No Press the Return soft key or wait
22. By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 48 of 84 Applied Biosystems 10 3 Operation Qualification continued Input Expected Output Acceptable Initials Date Yes No Enter 321 from keypad and 1 Display output 5 seconds Yes No O press the Accept soft key User name test PIN number XXX Protection Unlocked Press PIN to create a Then you set protection to Locked to prevent methods from being over written or deleted Invalid Password pin 2 Display output Confirm PIN Number Your PIN number protects the access to your user name and protection level Enter PIN number again PIN Press Accept to confirm you PIN Invalid Password pin Accept Cancel Enter 123 from keypad and Display output Yes No O press the Accept soft key User name test PIN number XXX Protection Unlocked Press PIN to create a Then you set protection to Locked to prevent methods from being over written or deleted Accept Name PIN Lock Cancel Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 49 of 84 Applied
23. Cycle 1 of 25 94 0 94 0 91 osos 0 30 5 00 Info Display output temperature may be blinking XX XX XM XC Method XXXXXXXX Run aborted at XX XX XX XM XX XX XX End of Run Length of run is XX XX XX Hist Display output Time Date Temp C Applied Biosystems 9800 System Version X XX User test Edit Display output Example Only Yes No U 2 Hld 3 Tmp 25 Cycles 2 Holds 94 0 94 0 72 0 72 0 0 30 5 00 Start Method exp 001 Start Method XX Return Fl F2 F3 F4 F5 Initials Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 56 of 84 Applied Biosystems Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 57 of 84 Applied Biosystems 10 3 Operation Qualification continued Input Expected Output Acceptable Initials Date Yes No Press the Return and Cancel soft Display output keys in succession Time Date Temp C Applied Biosystems 9800 System Version X XX Name XXXXX User lt lt ab gt gt Run Create Edit Util User Press the Run and User soft keys Display output in succession Select User Name lt lt
24. Cycler Maintenance Verification is covered by an Applied Biosystems Warranty or Service Contract or the user has a documented maintenance schedule and a record of maintenance 9 10 Installation Verification This procedure verifies that the Applied Biosystems 9800 FAST Thermal Cycler installation was completed as specified Perform and document verifications required by the Installation Verification data sheet The AB Design and this sentence must be BLUE in color Applied Biosystems Part Number 4374845 IQ OQ Protocol Revision c Page 11 of 84 9 11 Software Identification Verification This procedure verifies the establishment of software documentation and records for the Applied Biosystems 9800 FAST Thermal Cycler Perform and document the verifications required by the Software Identification Verification data sheet 9 12 IQ Completion Verification This section verifies that the IQ has been executed the IQ Report has been written and the IQ acceptance criteria have been met or explained Perform and document the verifications required by the IQ Completion Verification data sheet The AB Design and this sentence must be BLUE in color Part Number 4374845 TAS IQ OQ Protocol Revision C Page 12 of 84 9 2 Order Verification Perform and document the verification activities listed below Activity Method V D T 9 2 1 Verify that the product received matches the pro
25. ESP EYE EYE Re E ERE Roh 14 9 5 Utility Description VertfiCatlOn tecto ira toe tr eee e rp eV Ha Eee EE sedis ra roa rese yg ba tee ez ESSEER 15 9 6 Safety Materials Verification sssi 5 8 0 tomen e e iH Ri ORO EEUU Or ai A 16 9 7 Emissions and Immunity Compliance Verification tnter nennen tette tenete tentent 17 9 8 Laboratory Environmental Operating Conditions Verification essent eterne 18 9 9 Calibration and Maintenance Verification deett fscunosaseadadedcatecnsancovessadetseess OEA ERE a SAKLAR ne Aarie ie 19 9 11 Software Identification Verification 4 enn eere ree een eren reete noraen enano EEEN E RORE ENEAN aeo 21 9 12 COE Completion Verificati OM NR 22 Operation Qualification OQ Procedure n ariris 20 101 Procedure Tor OO BXeCUUlOIs as ccce etate AEO UP REO EROS ACE uo est c ters ec XN rt pee adeo bo YR EOS 23 10 2 Lossof Power VetifiCdtiOli eorr eit iv aaa O EEEREEST De E e EEUU EAE HTTP OSEE EO ETE 24 10 3 Operation QualifiCatlOB ote retento etre eate rere ta teta creer qe e en epa gei RE Enea eta iden eese UE OP 25 10 4 Customer Eatnili riz tion Vert fi Cati Om jc mines ca rtr bon E ER e OY HERE AERE EER sans ED EXE SEE SUE SERES AERE ESy EREMO 8 dg 81 IQ OQ Report and Protocol Final Approval eere eee ee eee eee testen statu seta tns en sets sn setatis sees ensenae 82 The AB Design and this sente
26. INCIDENTAL INDIRECT PUNITIVE MULTIPLE OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH OR ARISING FROM APPLIED BIOSYSTEMS PRODUCTS AND SERVICES OR THE USE OF THIS DOCUMENT Printed in the USA 12 2006 Part Number 4374845 Revision C 10 11 Part Number 4374845 Beenie IQ OQ Protocol Revision C Page 3 of 84 IQ OQ PROTOCOL TABLE OF CONTENTS Installation Qualification Operation Qualification IQ OQ Protocol Pre Approval 4 jiu i50 5 j 5 Nene 6 Responsibilities eee ee reete eene eee tenias tn atta tn sets tne ta sone tn sens tn sets suse tasse testo sets sse tasse enses enses snae 6 IOIOUUDSIPICN 7 Systemi D scripti e X 8 Recommendation for Performing the Instrument Performance Verification IPV TE ee 9 Installation Qualification IQ Procedure ee eese e eee eene e eee e eene esto seen Sette seen aseo sese toes esos esas seen 10 9 2 Order Verte Ath OM ayes 5 eicere DE re PREX eiae bep te TESA eps REEE EEE 12 9 3 Documentation V rification reri RETE EET UE SERRE E ERU E RRUEOT ER E CR Ne 13 9 4 System Description and Identification Verification sss is uoto trino ie RE SES Y Re ke SE eL go ha R
27. O in succession Thermal cycler test program 1 Hld 3 Tmp 25 Cycles 2 Holds 94 0 94 0 SNC 55 0 0 30 Start Store Print Using the key and circular Display output 5 seconds keypad highlight a test temp input 3 9 then highlight another Thermal cycler test program test temp 1 Hld 3 Tmp 25 Cycles 2 Holds i 94 0 94 0 22 0 i j 55 0 i 0 30 i Start Store Print Valid range is 4 0 to 99 9 Using the key and circular Display output 5 seconds keypads highlight a test temp Thermal cycler test program attempt to input 100 0 then highlight another test temp 1 Hid 3 Tmp 25 Cycles 2 Holds 94 0 94 0 72 0 55 0 0 30 Start Store Print Valid range is 4 0 to 99 9 Using the key and circular Display output keypad highlight a test temp Thermal cycler test program input 25 0 then highlight another test temp 1 Hld 3 Tmp 25 Cycles 2 Holds 94 0 94 0 2259 2 500 0 0 30 7 00 0 30 i Start Store Print More Cancel Fl F2 F3 F4 F5 Using the key and circular Display output Yes No O keypad highlight a test time Thermal cycler test program input 0 0 then highlight another test time 1 Hl1d 3 Tmp 25 Cycles 2 Holds 94 0 94 0 72 0 72 0 7 00 0 30 0 30 i Start Store Print More Cancel Fl F2 F3 F4 785 The AB Design and this sentence must be BLUE in color Part Nu
28. ab gt gt test test2 test XXXX Accept AII Cancel Using the Circular Key Display output highlight the lt lt ab gt gt and press All methods of lt lt ab gt gt displayed on screen the Accept soft key Cancel Press the Cancel soft key Display output Yes No U Time Date Temp C Applied Biosystems 9800 System Version X XX Name XXXXX User lt ab gt gt Run Create Edit Util User Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Applied Biosystems IQ OQ Data Sheets Part Number Revision Page 4374845 C 58 of 84 10 3 Operation Qualification continued Input Press the Run User amp All soft keys in succession Press the Cancel soft key Press the Edit User and All soft keys in succession Expected Output Display output All methods XXX displayed on screen Start View User Sort Cancel Display output Time Date Temp C Applied Biosystems 9800 System Name XXXXX User lt lt ab gt gt Create Edit Util Display output Methods User Size Last Used XXXX XXX XX XX XX XX XXXX XXX XX XX XX XX Edit View User Sort Cancel Alternate Screen Free Mem XX methods XXX segments XXXX XXX XX XX XX XX XXXX XXX XX XX XX XX Edit View User S
29. ancel Press the AM soft key Display output Yes LI No Instrument Configuration Time XX XX AM Date XX XX XX M D Y Run Time Printer Off Run Time Beep Off Accept 24 Hr PM More Cancel Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 30 of 84 Applied Biosystems 10 3 Operation Qualification continued Input Expected Output Acceptable Initials Date Yes No Press the PM soft key Display output Instrument Configuration Time XX XX PM Date XX XX XX M D Y Run Time Printer Off Run Time Beep Off Accept AM 24Hr More Cancel If the current time is in the AM Display output press the AM soft key Utilities If the current time is in the PM press the Accept key Diag Instrument diagnostics TmCalc Calculates melting temp Config Instrument configuration Diag TmCalc Config More Exit Press the Config then More soft Display output keys Instrument Configuration Pause Time Out 10 00 00 01 99 59 Idle State Set point 25 0 C 4 0 99 9 Baud Rate 9600 Accept Cancel Press the circular key to Display output Yes LI No highlight the following XX X Instrument Configuration Idle State Set Point Pa
30. and dated by the personnel carrying out the tests or checks 6 3 The protocol requires a reviewer s signature from a suitable person on each test or page and at the end of the report indicating the satisfactory review and check of the report results The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Protocol Revision C Page 8 of 84 Applied Biosystems 6 4 The personnel completing the protocol should enter any comments regarding their findings in the relevant comments section for the Final Approver s attention These may be continued in an appendix as necessary Individual comments must be initialed and dated The reviewers and approvers of the completed report may add their own initialed and dated responses to the comments if necessary 6 5 All printouts and other supporting data including CDs must be cross referenced to the specific test in this protocol signed and dated then inserted into the envelope at the back of the IQ OQ binder 7 System Description The Applied Biosystems 9800 FAST Thermal Cycler is an automated instrument designed for the amplification of nucleic acids using the Polymerase Chain Reaction PCR process The Applied Biosystems 9800 FAST Thermal Cycler has two components e Base module e Sample block module The base module has a user interface that consists of a control panel with a full numeric keypad with soft keys and a graphical display screen showing ti
31. ay output Cool and Heat Rate Test Blk XXX C Ramping sample block to 35 0 C Acceptable Yes No Initials Date Cancel Continue Display output Yes L No U Cool and Heat Rate Test Blk XX X C Stabilizing sample block at 35 0 C Cancel Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 38 of 84 Applied Biosystems 10 3 Operation Qualification continued Input Expected Output Acceptable Initials Date Yes No Continue Display output Yes No O Cool and Heat Rate Test Blk XX X C Ramping Block to 95 0 C Cancel Continue Display output Yes No O Cool and Heat Rate Test Blk XX X C Stabilizing sample block at 95 0 C For 1 min X XX Cancel Continue Display output Cool and Heat Rate Test Blk XX X C Ramping sample block to 4 0 C Cancel Continue Final screen Display output Yes No Cool and Heat Rate Test Pass Heating rate X XX C s Cooling rate X XX C s Print Cancel Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be
32. cation continued Input Expected Output Acceptable Initials Date Yes No Press the Exit soft key Display output Yes No O Time Date Temp C Applied Biosystems 9800 System Version XXX Name XXXX User xx Run Create Edit Util User Press the User soft key Display output Yes L No LJ highlight lt lt ab gt gt with the Select User Name Circular keypad lt lt ab gt gt XXX Accept New Edit Delete Cancel Press the New soft key Display output Yes LI No L abcdefghi jklmnopqr User Name SIUVWXYZ 0 Use ENTER key to select a character Accept Backsp Cancel Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 46 of 84 Applied Biosystems 10 3 Operation Qualification continued Input Expected Output Acceptable Initials Date Yes No Press the Enter Circular Dial Display output Yes No O amp Keypad to enter the name abcdefghi test1 jklmnopqr User Name test1 SIUVWXVZ 0 Use ENTER key to select a character Accept Backsp Cancel Press the Backsp soft key Display output abcdefghi jklmnopqr User Name test SIuVWXyz 0 Use ENTER key to select a character Accept Backsp Cancel Press the Keypad to
33. continued Input Expected Output Acceptable Initials Date Yes No Press the Sort soft key Display output Yes No O Sort Methods By Method name Date last used Date stored Method size Cancel With the Circular key highlight Display output sorted by Date last used Yes No U Date last used and press Methods User Size Last Used Accept soft key XXXX XXX XX XX XX XX XXXX XXX XX XX XX XX Edit View User Sort Cancel Alternate Screen Free Mem XX methods XXX segments XXXX XXX XX XX XX XX XXXX XXX XX XX XX XX Edit View User Sort Cancel Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 6l of 84 Applied Biosystems 10 3 Operation Qualification continued Input Expected Output Acceptable Initials Date Yes No Press the Sort soft key Display output Yes No O Sort Methods By Method Date Last used Date stored Method size Cancel With the Circular key highlight Display output sorted by Date stored Date stored and press Accept Methods User Size Stored soft key XXXX XXX XX XX XX XX XXXX XXX XX XX XX XX Edit View User Sort Cancel Alternate Screen Free Mem XX methods XXX segments XXXX XXX XX
34. creen goes OFF Press any button on the keypad Display output of last screen before screen saver mode or circular key is activated Utilities Diag Instrument diagnostics TmCalc Calculates melting temp Config Instrument configuration Diag TmCalc Config More Exit Press the Exit soft key Display output Time Date Temp C Applied Biosystems 9800 System Version X XX User ab Run Create Edit Util User Press the Run soft key highlight Display output HOT may be blinking AmpliTaq Gold method with the Circular Key and press the Sample XXX Start soft key two times in succession Thermal cycler test program running Pause Let the AmpliTaq Gold cycle Display output temperature may be blinking Yes No O run to 4 C hold Press the STOP key twice to XXGOURM End of Riri TEES abort the run Method XX Run completed at XX XX XX XM XX XX XX Length of run is XX XX XX Hist Store Press the power OFF key Screen goes blank and power light goes OFF Yes No U Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 81 of 84 Applied Biosystems 10 4 Customer Familiarization Verification Perform and
35. ction above The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Protocol Revision C Page 22 of 84 Applied Biosystems 9 12 IQ Completion Verification Perform and document the verification activities listed below Activity Method 1 Verify that the IQ has been completely executed 2 Verify that all exceptions have been investigated and documented Exceptions Comments Acceptance Criteria All the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date V Visually verified D Documentation reviewed and visually verified T Tested and deemed acceptable All verifications are reviewed and visually verified by the individual who signs the EXECUTED By Signature section above The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Protocol Revision C Page 23 of 84 Applied Biosystems 10 Operation Qualification OQ Procedure 10 1 Procedure for OQ Execution 10 1 1 The procedure can be performed by visual confirmation supporting documentation or by testing as described in the appropriate sections The method of confirmation is to be indicated in the Method column of each Verification Data Sheet attached to this document 10 1 2 Any discrepancies between the specified equipment parameters and those found on site ar
36. document the verification activities listed below Activity Method VIDIT 1 Verify that users have completed training on the operation of the Applied Biosystems 9800 FAST Thermal Cycler after installation of the system Attach documentation of the training to the envelope at the back of the IQ OQ binder if available Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date V Visually verified D Certification documentation reviewed and visually verified T Tested and deemed acceptable All verifications are reviewed and visually verified by the individual who signs the EXECUTED By Signature section above The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Report Approval Revision C Page 82 of 84 Applied Biosystems 11 IQ OQ Report and Protocol Final Approval Review and approve according to the procedures and quality system requirements of the organization that owns the instrument The completion of the Final Approval signatures indicates acceptance that the Applied Biosystems 9800 FAST Thermal Cycler Installation Qualification Operation Qualification Protocol has been executed in full Initial and date one of the following The Applied Biosystems 9800 FAST Thermal Cycler Instrument Performance Verification
37. duct ordered Use the Purchase Order or other documentation to verify Insert supporting documentation in the envelope at the back of the IQ OQ binder Exceptions Comments Acceptance Criteria There is documented evidence that the instrument on site is what was ordered except as noted above Conducted By Signature Date Customer Signature Date V Visually verified D Documentation reviewed and visually verified T Tested and deemed acceptable All verifications are reviewed and visually verified by the individual who signs the Conducted By Signature line above The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Protocol Revision C Page 13 of 84 Applied Biosystems 9 3 Documentation Verification Complete the table below Verify that the following user and service documents are available and the title for each document is correct On the Part Number and Revision lines enter the document part number and revision letter Activity Method VIDIT 9 3 1 Applied Biosystems FAST Thermal Cycler 9800 Base Module User s Manual Part number 4350088 Revision Location on site 9 3 2 Applied Biosystems 9800 Fast Thermal Cycler With 96 Well Aluminum Sample Block Module User Guide Part number 4350087 Revision Location on site Exceptions Comments Acceptance Criteria User and o
38. e Section 8 for more information about when to perform an Applied Biosystems 9800 FAST Thermal Cycler IPV Protocol 3 Purpose The purpose of this IQ OQ Protocol is to verify and record at the time of testing that the Applied Biosystems 9800 FAST Thermal Cycler is installed and operating in accordance with the Applied Biosystems installation and operation specifications described in this Protocol and that such tests confirm that the Applied Biosystems 9800 FAST Thermal Cycler is installed and at the time of testing operates in accordance with Applied Biosystems specifications set forth in the PCR System User s Manuals e 9800 Fast Thermal Cycler Base Module User Guide PN 4350088 e 9800 Fast Thermal Cycler with 96 Well Aluminum Sample Block Module PN 4350087 e CD FAST Thermal Cycler 9800 PN 4350542 The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Protocol Revision c Page 6 of 84 Applied Biosystems The performance of this IQ OQ Protocol results in an IQ OQ documentation package that includes completed Verification Data Sheets and identified attachments 4 Scope 4 1 The Applied Biosystems 9800 FAST Thermal Cycler including consumables and core instrument software associated with routine operation data collection analysis and reporting is qualified as part of the operational qualification of this system 4 2 This IQ OQ Protocol specifically applies to the Applied Biosystems 980
39. e to be documented and explained in the Comments Observations section of the appropriate Verification Data Sheet 10 1 3 Operation Qualification includes the following procedures in the sections indicated below Section and Procedure Description 10 2 Loss of Power This test verifies that the Applied Biosystems 9800 FAST Thermal Cycler is able to properly begin a new run after power is restored and that the Power Failure Test has been completed and documented 10 3 Operation Qualification This test is performed to check document and verify that the Applied Biosystems 9800 FAST Thermal Cycler meets the operational specifications for the Main Menu Screen and Function Verification for the Applied Biosystems 9800 FAST Thermal Cycler Perform and document the verifications required by the Operation Qualification Verification data sheet Include data generated with this protocol This procedure verifies that the instrument owner s received training on operation of the Applied Biosystems 9800 FAST Thermal Cycler Perform and document the verifications required by the Training of Users Verification data sheet 10 4 Training of Users Verification The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 24 of 84 iX Applied 59 Biosystems 10 2 Loss of Power Verification The Applied Biosystems 9800 FAST Thermal Cycler has been designed to cont
40. eate Edit Util User Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number IQ OQ Data Sheets Revision Applied Biosystems Page 4374845 C 74 of 84 10 3 Operation Qualification continued Input Expected Output Acceptable Yes No Press Util More Delete soft keys Display output Yes No O in succession Methods User Size Stored XXXX test2 X XX XX XX Delete View User Sort Cancel Alternate Screen Free Mem XX methods XXX segments XXXX test P XX XX XX Delete View User Sort Cancel Press the Delete soft key Display output Delete Method Methods User Size Stored XXX test2 X XX XX XX Press Yes to delete the method Yes Cancel Press the Yes soft key Display output Yes No U No Methods User Cancel Initials Date Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 75 of 84 Applied Biosystems 10 3 Operation Qualification continued Input Expected Output Acceptable Initials Date Yes No Pr
41. econnect the power source to Power light is ON red and instrument starts up the instrument or turn the instrument ON at gt 15 seconds and lt 3 minutes after power loss Display output The instrument determines what thermal cycler temperature was being approached or was holding and upon resumption of power the program will go to the temperature and countdown the time remaining in the hold as soon as the temperature is within the specified clock start limits Time ON Press the STOP keypad key Display output twice and then the Exit soft key Time Date Temp C Applied Biosystems 9800 System Version X XX User xx Run Create Edit Util Press the Util soft key and log Display output the time Site Utilities Yes L No Ll Diag Instrument diagnostics TmCalc Calculates melting temp Time Config Instrument configuration Diag TmCalc Config More Exit Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 80 of 84 Applied Biosystems 10 3 Operation Qualification continued Input Expected Output Acceptable Initials Date Yes No After 15 minutes from the Display output pressing of the Util soft key the Screen is OFF blank s
42. eets Revision C Page 44 of 84 10 3 Operation Qualification continued Input Expected Output Acceptable Initials Date Yes No Alternate Display output Yes No If the test fails repeat the EM H O procedure to make sure the digital thermometer was not misread or that data entry errors where not made Calibration Verification Instrument may require service Contact Applied Biosystems Ifthe test fails again contact Technical Support Applied Biosystems Technical Support Press the Exit soft key Display output Temperature Verification Temp Calibration Verification TNU Temperature Non Uniformity Temp TNU Exit Press the Exit soft key Display output Diagnostics Hard Hardware Diagnostics System System Performance Tests TmpVer Temperature Verification Upgrad Firmware Upgrade Hard System TmpVer Upgrad Exit Press the Exit soft key Display output Yes No Utilities Diag Instrument diagnostics TmCalc Calculates melting temp Config Instrument configuration Diag TmCale Config More Exit Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 45 of 84 Applied Biosystems 10 3 Operation Qualifi
43. enter the Display output Yes No O number 1 abcdefghi jklmnopqr User Name test SIuvWxyz wi tl Use ENTER key to select a character Accept Backsp Cancel Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number IQ OQ Data Sheets Revision Applied Biosystems Page 4374845 C 47 of 84 10 3 Operation Qualification continued Input Expected Output Acceptable Yes No Press the Accept soft key Display output User name test1 PIN number None Protection Unlocked Press PIN to create a Then you set protection to Locked to prevent methods from being over written or deleted Accept Name PIN f Cancel Press the PIN soft key Display output Create a PIN number Your PIN number protects the access to your user name and protection level Enter a PIN Number New Pin Accept Cancel Press the keypad s 123 and the Display output Yes LI No U Accept soft key Confirm PIN Number Your PIN number protects the access to your user name and protection level Enter PIN number again PIN t Press Accept to confirm you PIN Accept Cancel Initials Date Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted
44. ess the Cancel soft key Display output Yes No O Utilities Delete Delete a method Copy Copy methods from to PC card Hist Display history of last run Delete Copy Hist More Press the Exit soft key Display output Time Date Temp C Applied Biosystems 9800 System Version X XX User test2 Run Create Edit Util Press the User soft key Display output Select User Name lt lt ab gt gt XXX test2 test3 Accept New Edit Delete Cancel Use the Circular Key to select Display output Yes LI No U test2 name and press Delete Select User Name soft key lt lt ab gt gt XXX test3 Accept New Edit Delete Cancel Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 76 of 84 Applied Biosystems 10 3 Operation Qualification continued Input Expected Output Acceptable Initials Date Yes No Press the Cancel soft key Display output Yes No O Time Date Temp C Applied Biosystems 9800 System Version X XX User xx Run Create Edit Util User Press the User soft key Display output highlight test3 with the Time Date Temp C Circular Key and press the i Accept soft key Applied Biosystems 9800 System Version X XX User test
45. f the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Applied Biosystems Part Number IQ OQ Data Sheets Revision Page 4374845 C 32 of 84 10 3 Operation Qualification continued Input Press the circular key to highlight the following Screen Saver Smart Press the Accept soft key Press Config More More More soft keys in succession Verify NAME in display is the unit serial Expected Output Acceptable Yes No Display output Instrument Configuration Screen Contrast 7 1 20 Screen Saver Smart Never More Cancel Accept Always Display output Utilities Diag Instrument diagnostics TmCalc Calculates melting temp Config Instrument configuration TmCalc Exit Diag Config More Display output Instrument Configuration Get IP Off Name XXXXXXXX Accept More Cancel Display output Yes L No Instrument Configuration Get IP Off Name XXXX Unit S N Accept More Cancel Initials Date Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number ARM IQ OQ Data Sheets Revision Page 4374845
46. ification continued Input Expected Output Acceptable Initials Date Yes No Press the last blinking key to be Display output lit from test Hardware Diagnostics Disp LCD Display Diagnostic Keypad Keypad Diagnostic Disp Keypad Press the Exit soft key Display output Diagnostics Hard Hardware Diagnostics System Hard System Performance Tests TmpVer Temperature Verification Upgrad Firmware Upgrade Hard System TmpVer Upgrad Exit System Test Display output Yes No O Press the System soft key System Performance Rate Cool and Heat Rate Test Cycle Cycle Performance Test Rate Cycle Exit Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Applied Biosystems IQ OQ Data Sheets Part Number Revision Page 4374845 C 37 of 84 10 3 Operation Qualification continued Input Press the Rate soft key If a Consumable tray is not already installed in the instrument Place a Consumable tray into the unit and secure the lid Press the Cont soft key Expected Output Display output WARNING Install the appropriate empty Consumables into the Sample Block Refer to System Performance Section of Block User Manual Cancel Displ
47. igns the EXECUTED By Signature section above The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Protocol Revision C Biosystems Page 19 of 84 9 9 Calibration and Maintenance Verification Perform and document the verification activities listed below Activity 9 9 Verify that the 9800 Fast Thermal Cycler is covered by an Applied Biosystems warranty or service contract If applicable insert a copy of the most recently completed Applied Biosystems 9800 Fast Thermal Cycler Certificate of Analysis in the envelope at the back of this IQ OQ Protocol binder Note Some service contract types do not include scheduled maintenance Note Review the Applied Biosystems warranty of the 9800 Fast Thermal Cycler for warranty details including warranty period and coverage Planned Maintenance PM is not included in warranty coverage Warranty Contract expiration date If the 9800 Fast Thermal Cycler is not covered by an Applied Biosystems warranty or service contract verify that the customer has a documented maintenance schedule and record of maintenance performed for the 9800 Fast Thermal Cycler Insert supporting documentation in the envelope at the back of this IQ OQ Protocol binder 9 9 2 It is recommended that the Applied Biosystems 9800 Fast Thermal cycler have an annual calibration performed by an Applied Biosystems Repair center or Applied Biosystems authorized ser
48. inue a run after a power failure occurs However due to the inconsistent nature of unplanned power outages we recommend that the samples be re run The following verification is designed to ensure that if a power failure does occur the instrument is able to resume the run in progress properly after power is restored Activity Method V D T 1 While the Applied Biosystems 9800 FAST Thermal Cycler is in normal operation simulate the Loss of Power Test to the equipment system Perform Loss of Power by unlatching the Top Module latch part number N8051024 The Loss of Power Test requires a minimum of five 5 minutes After the power failure test restore power to the instrument system 2 Please circle yes or no to the following a Verifications Test Results Was the system operating normally prior to the simulated Power Losses yes no b When electrical power to the equipment system is removed the Applied Biosystems 9800 FAST Thermal Cycler is non operational yes no c Was the time period for the simulated power failure and restart greater than five 5 minutes yes no d When electrical power is restored to the system the Applied Biosystems 9800 FAST Thermal Cycler returns to its normal operating condition yes no The answer to ALL should be yes Exceptions Comments Acceptance Criteria There is documented evidence of training Conducted By Signature Date Customer Sig
49. l for the Applied Biosystems 9800 FAST Thermal Cycler and is responsible for revision control of the IQ OQ Protocol 5 2 The owners organization executing the IQ OQ Protocol is responsible for completing the Conducted By section associated with each task to indicate the verification was completed results were within any specifications identified and exceptions have been documented The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Protocol Revision C Page 7 of 84 Applied Biosystems 5 3 The instrument owner is responsible for reviewing the entries made and for accepting these entries by signing under Customer Signature This signifies customer agreement with the entries made In the case of exceptions recorded on the page the owner is responsible for resolving exceptions arising from instrument installation or operation that do not meet Applied Biosystems specifications 5 4 IQ OQ Protocol and Report Approval Signatures are to be completed according to the procedures of the instrument owner s organization Report approvals should be by individuals in the same function or organization that originally approved the IQ OQ Protocol 5 5 Should a new instrument in the process of installation not meet the operational specifications or other requirements in this IQ OQ Protocol Applied Biosystems will be responsible for effecting repair or replacement of the instrument to ensure operational s
50. mber 4374845 IQ OQ Data Sheets Revision C Page 64 of 84 Applied Biosystems 10 3 Operation Qualification continued Input Expected Output Acceptable Initials Date Yes No Using the key and circular Display output 5 seconds Yes No O keypad highlight a test time in Thermal cycler test program the cycle input 99 00 then highlight another test time 1 Hldi 3 Tmp 25 Cycles 2 Holds 94 0 94 94 0 2 72 0 72 0 i L 0 30 7 00 i 0 30 1 Start Store Print More Cancel Infinity hold not allowed in cycle Using the key and circular Display output 5 seconds keypad highlight a test time in Thermal cycler test program the cycle input 99 99 then highlight another test time 1 Hla 3 Tmp 25 Cyc les 2 Holds 94 0 94 0 72 0 72 0 k 0 30 7 00 i 0 30 Start Store Print More Cance Seconds must be 0 59 Using the key and circular Display output keypad highlight a test time in Thermal cycler test program the cycle input 98 59 then highlight another test time 1 Hd 3 Tmp 25 cycles 2 Holds 94 0 94 0 72 0 72 0 0 30 7 00 0 30 1 T 1 1 i i Start Store Print More Cancel Fl F2 F3 F4 HS Using the key and circular Display output keypad highlight a test time in Thermal cycler test program with ce as last time entry the last thermal cycler entry input 99 00 then highligh
51. me and temperature profiles for each run as well as pre PCR holds PCR cycling and post PCR holds The sample block modules are interchangeable to allow changes in sample well formats and throughput capacity The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Protocol Revision C Page 9 of 84 Applied Biosystems 8 Recommendation for Performing the Instrument Performance Verification IPV Protocol Applied Biosystems recommends that the Applied Biosystems 9800 FAST Thermal Cycler Instrument Performance Verification IPV diagnostics be performed to verify performance of the instrument after any of the following events e Replacement of any part that is critical to the performance of the Applied Biosystems 9800 FAST Thermal Cycler e Performance of any service procedure that may affect instrument performance The following table lists the applicable parts and procedures Part Service Maintenance Procedure Applied Biosystems 9800 FAST Thermal Cycler Tests and Diagnostics e Applied Biosystems 9800 Fast Thermal Cycler With 96 Well Aluminum Sample Block Module Users Guide Part Number 4350087 Chapter 2 o The Calibration Verification Test Pages 2 2 to 2 8 o System Performance Diagnostics Pages 2 16 to 2 18 Note Pass Fail Criteria are outlined in the users manual at the end of each section The AB Design and this sentence must be BLUE in color Applied Bio
52. nature Date V Visually verified D Certification documentation reviewed and visually verified T Tested and deemed acceptable All verifications are reviewed and visually verified by the individual who signs the Conducted by section above The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 25 of 84 Applied Biosystems 10 3 Operation Qualification From the user s interface enter each of the screens specified in the table below Confirm by checking Yes or No that each of the screens listed in the table below is accessible from the user s interface and functions as specified Note A response of X in the Expected Output can stand for any alphanumeric symbol Input Expected Output Acceptable Initials Date Yes No Press the power switch to the Power light on front panel is lit red Yes No O ON position system start up cycling System starts up cycling A whirling fan sounds Display output APPLIED BIOSYSTEMS www appliedbiosystems com System starts up cycling Display output Applied Biosystems Applied Biosystems 9800 System Fast Thermal Cycler Version X XX System start up cycle Display output Complete Time Date Temp C Applied Biosystems 9800 System Version X XX Name XXXX User xxxx Run Create Edit Util User Press the Ufil soft key Display output Yes 1 No L Utilities Diag Instrument diagnostics
53. nce must be BLUE in color Part Number 4374845 IQ OQ Protocol Revision C Page 4 of 84 Applied Biosystems 1 Installation Qualification Operation Qualification 1Q OQ Protocol Pre Approval 1 1 Review and approve this IQ OQ Protocol according to the procedures and quality system requirements of the organization that owns the instrument At a minimum the instrument owner and the owner s quality department must sign in ink below 1 2 Approve the IQ OQ Protocol prior to performing the protocol by completing the approvals below Add more signatures as required Fill in any blank spaces below with N A indicating Not Applicable Other departments affected by the outcome of the IQ OQ process are recommended to review and approve this IQ OQ Protocol 1 3 The completion of the approvals below indicates that the Applied Biosystems 9800 FAST Thermal Cycler IQ OQ Protocol e Has been reviewed and approved by the instrument owner and the quality representative of the organization that owns the instrument e Is ready to be performed Pre Approval Print Name Signature Title Date Print Name Signature Title Date Print Name Signature Title Date Print Name Signature Title Date Print Name Signature Title Date Print Name Signature Title Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Protocol Revision C Page 5 of 84 Applied Biosystems
54. on XXXX testl X XX XX XX Delete View User Sort Cancel Alternate Screen Free Mem XX methods XXX segments XXXX test1 X XX XX XX Delete View User Sort Cancel Press the Delete soft key Display output Security Check To perform this action you must enter you PIN number Your PIN Delete Cancel Enter PIN 123 with key tab Display output Yes No U and press the Accept soft key Delete Method Press Yes to Delete method Methods User Size Stored XXX testl X XX XX XX Press Yes to delete the method Mes Cancel Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 70 of 84 Applied Biosystems 10 3 Operation Qualification continued Input Expected Output Acceptable Initials Date Yes No Press the Cancel soft key Display output Yes No O Methods User Size Stored XXXX test X XX XX XX Delete View User Sort Cancel Alternate Screen Free Mem XX methods XXX segments XXXX test X XX XX XX Delete View User Sort Cancel Press Delete soft key Display output Security Check To perform this action you must enter you PIN number Your PIN Accept Enter PIN 123 with key tab Display output Yes No U and press the Accept
55. ort Cancel Acceptable Yes No Yes No O Yes LI No HO Initials Date Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 59 of 84 Applied Biosystems 10 3 Operation Qualification continued Input Expected Output Acceptable Initials Date Yes No Press the Sort soft key Display output Yes No O Sort Methods By Method name Date last used Date stored Method size Cancel With the Circular key highlight Display output sorted alphabetically by Method name Yes No U Method name and press Accept Methods User Size Last Used soft key XXXX XXX XX XX XX XX XXXX XXX XX XX XX XX Edit View User Sort Cancel Alternate Screen Free Mem XX methods XXX segments XXXX XXX XX XX XX XX XXXX XXX XX XX XX XX Edit View User Sort Cancel Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 60 of 84 Applied Biosystems 10 3 Operation Qualification
56. ow Requirement Method VD T 9 8 1 Verify that the laboratory meets the Altitude Requirements as specified in the Temperature Humidity and Environment section of the Applied Biosystems 9800 Fast Thermal Cycler With 96 Well Aluminum Sample Block Module Users Guide Insert supporting documentation in the envelope at the back of the IQ OQ binder Page number 9 8 2 Verify that the laboratory meets the Pollution Requirements as specified in the Temperature Humidity and Environment section of the Applied Biosystems 9800 Fast Thermal Cycler With 96 Well Aluminum Sample Block Module Users Guide Insert supporting documentation in the envelope at the back of the IQ OQ binder Page number 9 8 3 Verify that the laboratory meets the Temperature and Humidity Requirements as specified in the Temperature Humidity and Environment section of the Applied Biosystems 9800 Fast Thermal Cycler With 96 Well Aluminum Sample Block Module Users Guide Insert supporting documentation in the envelope at the back of the IQ OQ binder Page number Exceptions Comments Acceptance Criteria Documentation reflects requirements in Chapter 1 of the Site Preparation Guide Conducted By Signature Date Customer Signature Date V z Visually verified D Documentation reviewed and visually verified T Tested and deemed acceptable All verifications are reviewed and visually verified by the individual who s
57. pecifications are met subject to the terms of the Applied Biosystems warranty Ifthe execution of the IQ OQ Protocol activities are interrupted by an instrument or power failure due to main power loss or disruption the owner will of the instruments will be responsible for purchasing a new IQ OQ Protocol to certify the instrument Any damage to the instrument caused by such a power disruption will be repaired at the owner s expense No refunds will be granted 5 6 Ifa previously installed instrument does not meet the operational specifications or other requirements in this protocol the instrument owner is responsible for repairing the instrument or having it repaired at the owner s expense except to the extent that the instrument and the required repairs are covered by an Applied Biosystems warranty or service contract If the execution of the IQ OQ Protocol activities are interrupted by failure to meet such specification or other requirement the owner of the instruments will be responsible for purchasing a new IQ OQ Protocol to certify the instrument and the owner will be responsible for purchasing a new IQ OQ Protocol to certify the instrument No refunds will be granted 6 Reporting Data 6 1 The completed IQ OQ will consist of this approved IQ OQ Protocol completed in clear handwriting in blue or black ink with appended documents as listed in data sheet sections 6 2 When each test page or check page is completed it shall be signed
58. pt soft key Display output Time Date Temp C Applied Biosystems 9800 FAST Thermal Cycler Version X XX User testl Run Create Edit Util User Press the Create soft key Display output Default Method 1 Hld 3 Tmp 25 Cycles 94 0 94 0 32 0 55 0 0 30 Start Store Print F2 Store Press the Store soft key Display output Store Method on Instrument User test Method XX Ramp Mode HS96 or STD Free Mem XXX methods XXX segments Accept User Method Cancel Acceptable Initials Date Yes No Yes No O Yes L No U Exceptions Comments The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 51 of 84 Applied Biosystems Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 52 of 84 Applied Biosystems 10 3 Operation Qualification continued Input Expected Output Acceptable Initials Date Yes No Press the Accept soft key Display output Yes No O Time Date Temp C Applied Biosystems 9800 System Version XXX Name XXXX User test Create Edit Util Using the previous Display output methodology create thermal Time Date Temp C cycler test2 PIN 123 amp unlocked and test
59. r Part Number 4374845 IQ OQ Data Sheets Revision C Page 27 of 84 Applied Biosystems 10 3 Operation Qualification continued Input Expected Output Acceptable Initials Date Yes No Press the D M Y soft key Display output Instrument Configuration Time XX XX PM Date XX XX XX D M Y Run Time Printer Off Run Time Beep Off Accept Y M D M D Y More Cancel Press the Y M D soft key Display output Instrument Configuration Time XX XX PM Date XX XX XX Y M D Run Time Printer Off Run Time Beep Off Accept M D Y D M Y More Cancel Press the M D Y soft key Display output Yes No O Instrument Configuration Time XX XX PM Date XX XX XX M D Y Run Time Printer Off Run Time Beep Off Accept D M Y Y M D More Cancel Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Applied Biosystems Part Number IQ OQ Data Sheets Revision Page 4374845 C 28 of 84 10 3 Operation Qualification continued Input Press the circular key to highlight the following Off run time printer Press the On soft key and then the Off soft key Press the circular key to highlight the following Off run time beep Expected Output Acceptable Yes No Display outpu
60. r Service documents are on site or available except as noted above Conducted By Signature Date Customer Signature Date V Visually verified D Documentation reviewed and visually verified T Tested and deemed acceptable All verifications are reviewed and visually verified by the individual who signs the Conducted By Signature line above The AB Design and this sentence must be BLUE in color Part Number 4374845 Applied AR Biosystems IQ OQ Protocol Revision C Page 14 of 84 9 4 System Description and Identification Verification Perform and document the verification activities listed below Activity Method 9 4 1 Verify that the general description of the Applied Biosystems 9800 Fast Thermal Cycler as specified in Section 7 of this IQ OQ Protocol matches the installed system 9 4 2 Complete the following a Applied Biosystems 9800 Fast Thermal Cycler Base Module Equipment Model Serial Number Lab Location Applied Biosystems 9800 Fast Thermal Cycler Sample Block Module Equipment Model Serial Number Lab Location b Optional Printer Manufacturer Equipment Number Serial Number Lab Location Exceptions Comments Acceptance Criteria All the above information has been verified and is acceptable except as noted above Conducted By Signature Date Customer Signature
61. scription and This procedure verifies the identity of the system and subsystems of the Applied Identification Verification Biosystems 9800 FAST Thermal Cycler Perform and document verifications required by the System Description and Identification Verification data sheet 9 5 Utility Description This procedure verifies the existence of the utilities required to operate the Verification Applied Biosystems 9800 FAST Thermal Cycler Perform and document the verifications required by the Utility Description Verification data sheet 9 6 Customer Supplied This procedure verifies the existence of the list of Applied Biosystems Materials Verification recommended customer supplied materials Perform and document the verifications required by the Customer Supplied Materials Verification data sheet 9 7 Emissions and Immunity This procedure verifies that the Emissions and Immunity status documentation are Compliance Verification present and acceptable Perform and document the verifications required by the Emissions and Immunity Compliance Verification data sheet 9 8 Laboratory Environmental This procedure verifies the identification of environmental conditions for the Operating Conditions Applied Biosystems 9800 FAST Thermal Cycler Perform and document the Verification verifications required by the Laboratory Environmental Operating Conditions Verification data sheet 99 Calibration and This procedure verifies that the Applied Biosystems 9800 FAST Thermal
62. soft key Delete Method Methods User Size Stored XXX testl X XX XX XX Press Yes to delete the method Mes Cancel Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 7 of 84 Applied Biosystems 10 3 Operation Qualification continued Input Expected Output Acceptable Initials Date Yes No Press the Yes soft key Display output Yes No O No Methods User Cancel Press the Cancel soft key Display output Utilities Delete Delete a method Copy Copy methods from to PC card Hist Display history of last run Delete Copy Hist More Press the Exit soft key Display output Yes L No Time Date Temp C Applied Biosystems 9800 System Version X XX User test Run Create Edit Util User Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 72 of 84 Applied Biosystems 10 3 Operation Qualification continued Input Expected Output Acceptable Initials
63. stems 9800 Fast Thermal Cycler With 96 Well Aluminum Sample Block Module Users Guide Page number Insert supporting documentation in the envelope at the back of this IQ OQ Protocol binder Exceptions Comments Acceptance Criteria All the above information has been verified and documented and is acceptable except as noted above Conducted By Signature Date Customer Signature Date V Visually verified D Documentation reviewed and visually verified T Tested and deemed acceptable All verifications are reviewed and visually verified by the individual who signs the Conducted By Signature line above The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Protocol Revision C Page 16 of 84 Applied Biosystems 9 6 Safety Materials Verification Confirm and document the verification requirements listed below Requirement Method 9 6 1 Verify that the user supplied safety equipment as specified in the Applied Biosystems 9800 Fast Thermal Cycler With 96 Well Aluminum Sample Block Module Users Guide Chemical safety guidelines section are available Page number Exceptions Comments Acceptance Criteria The above requirements have been met in accordance with the site safety regulations Conducted By Signature Date D T Customer Signature Date V Visually verified D Documentation
64. systems Part Number 4374845 C 10 of 84 IQ OQ Protocol Revision Page 9 Installation Qualification IQ Procedure 9 Procedure for IQ 9 1 1 The procedure can be performed by visual confirmation supporting 9 1 2 9 1 3 documentation or by testing as described in the appropriate sections The method of confirmation is to be indicated in the Method column of each Verification Data Sheet attached to this document Any discrepancies between the specified equipment parameters and those found on site are to be identified under exceptions and explained in the Comments Observations section on the appropriate Verification Data Sheet Installation Qualification includes the following procedures in the sections indicated below Section and Procedure Description 9 2 Order Verification This procedure verifies that the Applied Biosystems 9800 FAST Thermal Cycler was received as ordered in name and part number Perform and document the verifications required in the Order Verification data sheet If available attach a copy of the Purchase Order Purchase Requisition or other ordering documentation to this IQ OQ documentation package 9 3 Documentation Verification This procedure verifies the existence of documentation available for use prior to the execution of the IQ OQ Perform the document verifications required by the Documentation Verification data sheet 9 4 System De
65. t Instrument Configuration Time XX XX PM Date XX XX XX M D Y Run Time Printer Off Run Time Beep Off Accept On Off More Cancel Display output Run Time Printer highlight on the LCD screen toggles On then Off Display output Instrument Configuration Time XX XX PM Date XX XX XX M D Y Run Time Printer Off Run Time Beep Off Initials Date Accept On Off More Cancel Press the On soft key and then Display output Yes LI No the Off soft key Run Time Beep highlight on the LCD screen toggles On then Off Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Customer Signature Date Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 29 of 84 Applied Biosystems 10 3 Operation Qualification continued Input Expected Output Acceptable Initials Date Yes No Press the circular key to Display output XX XX highlighted on time Yes No O highlight the following XX Instrument Configuration XX Time Time XX XX PM Date XX XX XX M D Y Run Time Printer Off Run Time Beep Off Accept AM 24Hr More Cancel Press the 24 Hr soft keys Display output Instrument Configuration Time XX XX 24 Hour Date XX XX XX M D Y Run Time Printer Off Run Time Beep Off Accept PM AM More C
66. t a 1 Hld 3 Tmp 25 Cycles 2 Holds previous test time 94 0 94 0 Sr 0 30 7 00 i 0 30 Start Store Print More Cancel Fl F2 F3 F4 F5 Press the Cancel soft key Display output Yes No Time Date Temp C Applied Biosystems 9800 System Version X XX User xx Run Create Edit Util User The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 65 of 84 Applied Biosystems Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number IQ OQ Data Sheets Revision Applied Biosystems Page 4374845 C 66 of 84 Input Expected Output Acceptable Yes No Press the Create soft key Display output Example Only Yes No O 1 Hld 3 94 0 Start re Print Cancel Fl HS Press the Start soft key Display output Yes No O Select Method Options Reaction volume 31 uL Ramp speed HS96 or Std Run ID 1 Enter a value from 5 to 30 uL Start Cancel Please wait while the Heated Display output cover heats up Please wait Cover is heating Current temperature XXX C The run will begin when the heated cover reaches 103 C Cancel The Blinking line on the graphic Display output Example Only Yes
67. table Initials Date Yes No Press the User soft key Display output Yes No O Select User Name lt lt ab gt gt XXXX testl test2 test3 Accept New Edit Delete Cancel Use the Circular Key to select Display output test name and press Accept Time Date Temp C soft key Applied Biosystems 9800 System Version X XX User testl Run Create Edit Util User Press the User soft key Display output Select User Name lt lt ab gt gt XXXX testl test2 test3 Accept New Edit Delete Cancel Use the Circular Key to select Display output Yes No O testl name and press Delete Select User Name soft key lt lt ab gt gt XXXX test test2 test3 Delete your methods first Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845 Applied Revision C 69 of 84 Biosystems IQ OQ Data Sheets Page 10 3 Operation Qualification continued Input Wait 5 seconds for previous output screen to change Press Cancel Util More Delete Expected Output Acceptable Yes No Display output Yes No O Select User Name lt lt ab gt gt XXXX test test2 test3 Accept New Edit Delete Cancel Display output Methods User Size Stored Initials Date soft keys in successi
68. uctions in the Applied Biosystems 9800 Fast Thermal Cycler Base Module User Guide Exceptions Comments Acceptance Criteria All the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date V Visually verified D Documentation reviewed and visually verified T Tested and deemed acceptable All verifications are reviewed and visually verified by the individual who signs the EXECUTED By Signature section above The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Protocol Revision C Page 21 of 84 Applied Biosystems 9 11 Software Identification Verification Perform and document the verification activities listed below Activity Method 9 11 1 Verify that the version o firmware installed on the Applied Biosystems 9800 FAST Thermal Cycler Instrument Firmware Minimum Version required 1 0 Version installed Exceptions Comments Acceptance Criteria The following signatures indicate that the software verifications above have been documented and any exceptions noted Conducted By Signature Date Customer Signature Date V Visually verified D Documentation reviewed and visually verified T Tested and deemed acceptable All verifications are reviewed and visually verified by the individual who signs the EXECUTED By Signature se
69. use Time Out 10 00 00 01 99 59 Idle State Set point 25 0 C 4 0 99 9 Baud Rate 9600 Accept More Cancel Exceptions Comments Acceptance Criteria The results of the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Data Sheets Revision C Page 31 of 84 Applied Biosystems 10 3 Operation Qualification continued Input Expected Output Acceptable Initials Date Yes No Press the circular key to Display output highlight the following Instrument Configuration XXXX Baud Rate Pause Time Out 10 00 00 01 99 59 Idle State Set point 25 0 C 4 0 99 9 Baud Rate 9600 Accept Up Down More Cancel Press the Up soft key once and Display output for the Baud Rate reads 19200 when the the Down soft key once Press Up soft key is pressed and 9600 when the Down soft key the Accept soft key is pressed Press the Config More amp More Display output soft keys in succession Instrument Configuration Screen Contrast 7 1 to 20 Screen Saver Smart Accept Up Down More Cancel Press the Up soft keys once then Display output for Screen Contrast increases to 8 then Yes No O the Down soft key once decreases to 7 as the soft keys are pressed Exceptions Comments Acceptance Criteria The results o
70. vice provider using a multi channel calibration system tool The instrument that is having the IQ OQ performed must have a calibration performed prior to the execution of the IQ OQ Protocol Insert the most recent Certificate of Analysis in the envelope at the back of the IQ OQ binder Note Applied Biosystems does not endorse the suitability of any proposed maintenance plan or schedule that is not provided by Applied Biosystems for this instrument Any customer electing not to have an instrument covered by an Applied Biosystems Service Contract or Maintenance agreement must clearly document all maintenance activities performed on the instrument for future reference Exceptions Comments Acceptance Criteria All the above activities have been verified and are acceptable Conducted By Signature Date Customer Signature Date V Visually verified D Documentation reviewed and visually verified T Tested and deemed acceptable All verifications are reviewed and visually verified by the individual who signs the Executed By Signature section above The AB Design and this sentence must be BLUE in color Part Number 4374845 IQ OQ Protocol Revision C Page 20 of 84 Applied Biosystems 9 10 Installation Verification Perform and document the verification activities listed below Activity Method 9 10 1 Verify that the system components are unpacked according to the instr

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