Validation Document Review/Approval

Validation Review

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:

  1. Layout/Format
    1. Is the document number and title correct and consistent throughout the document?
    2. 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
    3. Are the page numbers correct?
    4. Are the footers correct and consistent throughout the document (e.g. “confidential” stamp, reviewed by on appropriate pages only)
    5. Are the fonts and font sizes used consistently though the document?
    6. Is the Table of Contents correct?
    7. Is there any approval page, if required?
    8. Are paragraphs aligned correctly?
    9. Are diagrams and figures appropriately labelled and referenced?
    10. Are attachments, appendices, etc. appropriately labelled and referenced?
  2. Content
    1. Is the purpose and scope of the document clear?
    2. Are appropriate documents referenced?
    3. Are responsibilities clearly described?
    4. Are reference/source documents correct?
    5. Are test procedures and methods described with enough detail?
    6. Are acceptance criteria clear and concise?
    7. Is there a deviation/exception/discrepancy procedure included or referenced?
    8. Do test forms contain sufficient detail to allow the test to be performed the same way by any qualified person?
    9. Is there a way to index test attachments so that they are fully traceable? Is the attachment procedure included or referenced?
    10. Is the final report/package procedure included or referenced?

What else do you look for?

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