21 CFR Part 11 Electronic Record and Electronic Signatures is a section of the Code of Federal Regulations (CFR) which outlines the FDA (Food and Drug Administration) standard for computerized systems pertaining to Electronic Records and Electronic Signatures. 21 CFR Part 11 regulation applies to pharmaceutical, biotech, biologic developers and others FDA regulated sectors. The goal is to ensure integrity of traceability data throughout the entire product life cycle, from research, development, records, production, distribution and eventual recall.
IASTECH professionals have an extensive knowledge to comply with the FDA regulation.