Glossary of Terms
21 CFR Part 11
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulation of Electronic Records that establishes the FDA regulations on electronic records and electronic signatures. Part 11 defines the criteria under which electronic records are considered trustworthy, reliable, and equivalent to paper records. Part 11 applies to drug makers, MD manufacturers, biotech companies, biologics developers, CROs, and other FDA-regulated industries, with some specific exceptions.  It requires that they implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing the electronic data that FDA predicate rules require them to maintain.

Part 11 does not mandate the use of electronic systems, but it specifies the requirements for companies that choose to use electronic systems in their compliance efforts. It allows the use of electronic records as much as possible and safeguards the integrity of data and systems and data validity (or nonrepudiation) of electronic signatures. At the same time, data integrity is a critical part in ensuring the safety of medical products.

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