Flexar Analytical / FX-10 UHPLC Pump
IQ/OQ Rev. D June 2009
Appendix B– Change Control
Note: Create copies of this page, leaving original blank. Read instructions below.
Change Control procedures maintain the validation processes after modifications are made to the original
configuration (by OEM, Template-Company, or PerkinElmer LAS).
The Change Control Form is located in Appendix B– Change Control and instructions are located in the
Introduction. Insert the completed Change Control Form and its data into this validation document as an
Attachment.
Change Control Revision Attachment #: __
Component / Software Changed
________________________________________________________________________________________
________________________________________________________________________________________
Reasoning and Justification for Change
________________________________________________________________________________________
________________________________________________________________________________________
Verification of New Component / Software
________________________________________________________________________________________
________________________________________________________________________________________
Acceptance Criteria Used
________________________________________________________________________________________
________________________________________________________________________________________
Results of Verification
(Attach original data)
________________________________________________________________________________________
________________________________________________________________________________________
Validation Results
Validation
Pass/Fail
Signature
Date
Performed By:
Approved By:
