Hello good people of the world! Today’s post is about things to consider in reviewing a validation protocol from a Validation approver perspective. I look at:
- Is the document number and title correct and consistent throughout the document?
- Is the header correct and consistent throughout the document (every page should have, at a minimum, the document number, title, page number, and total pages
- Are the page numbers correct?
- Are the footers correct and consistent throughout the document (e.g. “confidential” stamp, reviewed by on appropriate pages only)
- Are the fonts and font sizes used consistently though the document?
- Is the Table of Contents correct?
- Is there any approval page, if required?
- Are paragraphs aligned correctly?
- Are diagrams and figures appropriately labelled and referenced?
- Are attachments, appendices, etc. appropriately labelled and referenced?
- Is the purpose and scope of the document clear?
- Are appropriate documents referenced?
- Are responsibilities clearly described?
- Are reference/source documents correct?
- Are test procedures and methods described with enough detail?
- Are acceptance criteria clear and concise?
- Is there a deviation/exception/discrepancy procedure included or referenced?
- Do test forms contain sufficient detail to allow the test to be performed the same way by any qualified person?
- Is there a way to index test attachments so that they are fully traceable? Is the attachment procedure included or referenced?
- Is the final report/package procedure included or referenced?
What else do you look for?
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