PerkinElmer FX-10 UHPLC Manual page 5

Template-Company
Template-SN
Once an entry has been made (other than "None") any remaining space in the Comments (either single or
multiple blank lines) requires a single diagonal line filling the area, along with initials and date next to the line.
EXCEPTION: DO NOT cross out blank lines on the "Error Code Abbreviation, Definition and Making Corrections"
page. These pages or sections are either copied for future documentation needs or provide space to maintain
records into the future.
Acceptance Criteria
All tests must include values for acceptance criteria and the results of that test must be included.
Precision and Accuracy Measurements
The following areas of precision and accuracy will be noted on a per-test basis.
All instrument precision values (when available) will be noted within the OQ document. All data entered into the
OQ document will reflect these values.
For example: If a precision value of four significant digits is supplied for a test by the manufacturer, then all four
digits will be entered with the last digit being rounded down if the fifth digit is below 5, rounded up if above 5, and
rounded up if fifth digit is 5.
Failure Mode Responses
If a test result is determined to be outside of the precision parameters set forth by manufacturer of instrument, it
will be discussed with the customer first and if agreed both by customer and PerkinElmer then it will be repeated
a second time to confirm the result. If the second result fails, the instrument owner will be contacted to discuss a
reasonable course of action. If however, the second test passes, a note will be made as to the reason for the
primary failure and the second test data will be used.
Test -> Fail -> Repeat -> PASS -> Report 2
Deviation
Deviations are events that are a departure from the specific protocol procedures as they were approved.
Deviations to the plan are permitted if those deviations are clearly detailed, approved by all parties and entered in
Appendix - Deviations
Change Control
Change control procedures are in place to maintain the validation process after modifications are made to the
original configuration. Any changes to the hardware, firmware or software of a validated system must be clearly
specified and the validation confirmed and recorded.
1. A blank Change Control form is located in Appendix C. Consider making photocopies when blank.
2. If used, insert a completed Change Control Form and its associated data as an Attachment.
Flexar Analytical / FX-10 UHPLC Pumps IQ/OQ Rev. D June 2009
nd
result
IQ / OQ
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