Part 11 Spreadsheet Assessment
Assess a GMP spreadsheet for predicate-rule record use, validation, access, audit trail, and retention controls.
A shared-drive spreadsheet calculates assay values used for batch release, but formulas and access are weakly controlled. Part 11 assessment: predicate-rule use -> record authority -> validation -> access/change controls -> retention The shortcut is saying, "We print the final page, so Part 11 does not matter." If the spreadsheet performs the regulated calculation and the printout is not a complete and accurate copy of the electronic source and formula history, the risk remains. Use Define regulated reliance: the spreadsheet calculates assay results that QA uses for batch release. Scope starts with how the record is used. Release reliance makes…
Sign up free — one personalized lesson every day, matched to your role and goals.
Already have an account? Sign in