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2.1
Operating Procedure References
2.1.1
Standard Operating Procedures pertaining to the Flexar Analytical / FX-10
UHPLC Pump
It is responsibility of the customer to follow a SOP for use of the equipment to ensure consistent operations.
The customer SOP may be written after the Qualification and can be added as an attachment after
PerkinElmer completes this IQ/OQ.
2.2
Operational Qualification Instruction
The following instructions apply to the Operational Qualification Test Description
2.2.1
Record Model (or Part Number) and Serial Number of any accessories or components not covered in
the OQ
2.2.2
Record the Serial Number and Calibration Date for each item of Test Equipment used.
2.2.3
Record the Batch/Lot Number and Expiration Date of each Standard, Reagent and Solvent used,
including those supplied by the customer.
2.2.4
Label all solutions prepared at customer site in accordance with the customer requirements (date,
content, expires by, etc)
2.2.5
Provide the Standard certificates as Attachments.
The following instructions apply to the Parameter Testing
2.2.6
Conduct Parameter Testing and record test data, Pass/Fail and Comments.
2.2.7
Verify the completed OQ in Section 2.5
2.2.8
Sign, date and number attachments of all recordings or printouts made during the test procedure (ex.
settings,
spectrograms).
2.2.9
Fill in All Appendices, as required.
2.2.10
Complete and sign off the Final Approval
2.2.11
Complete and affix an IQ/OQ Certification Sticker to the instrument.
Comments:
PerkinElmer LAS Representative:
Reviewed By:
Flexar Analytical / FX-10 UHPLC Pump IQ/OQ Rev. D June 2009
Date:
Date:
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