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INFO: What is 21 CFR Part 11?
… INFO: What is 21 CFR Part 11? What is 21 CFR Part 11? Title 21 Code of … trial. Applies to computerized systems that create source documents (electronic records) that satisfy the requirements … a laboratory information system). Applies to when source documentation is created in hardcopy and later entered into a …
INFO: 21 CFR Part 11: SDLC and Systems Validation
… INFO: 21 CFR Part 11: SDLC and Systems Validation What is 21 CFR … or coding Testing Deployment Maintenance Most SDLC documentation consist of: Validation Plan System Requirements … validation effort - an auditor should not say you have documented something incorrectly, just that you either did …