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What is 21 CFR Part 11?

The FDA (Food and Drug Administration) provides regulations for the health industry. The central set of regulations for Laboratories is defined in the Good Laboratory Process (GLP) rules. Any Laboratory that executes clinical studies and trials submit their results to the FDA for further inspection. Therefore, the FDA controls whether an institution is GLP compliant or not. To facilitate the submission of results, the FDA approached the electronic submission of records. To ensure reliable submission, exchange, generation and maintenance of data, the FDA established requirements and regulations under the title 21 of the CFR (Code of Federal Regulations) within its Part 11. This set of regulations establishes baseline standards for electronic records managed by computer systems. Part 11 applies to systems that create, modify and maintain electronic data. Regarding the usage of computer systems, it is important to emphasize that compliance within an organization can only be established when the complete organizational process meets the requirements. Therefore, compliance can only exist for both components together, the software itself AND the organizational environment.

21 CFR Part 11 requirements:

Key requirements include

System Validation. This includes Software Validation (21 CFR Part 11.10a)
Electronic Signatures: Computer data compilation of any symbol, adopted or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature (21 CFR Part 11.1c)
Audit trails: Traceability of changes on the original data, including notes on why the data has been changed, when and by whom (21 CFR Part 11.10e)
Ability to discern and detect manipulated or corrupted data records (21 CFR Part 11.10a)
Device checks (21 CFR Part 11.10h)

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