Context: 21 CFR Part 11 is the FDA regulation for electronic records and signatures (ER/ES). It defines when ER/ES in FDA-regulated processes are considered trustworthy, reliable and generally equivalent to paper records and handwritten signatures.
Why it matters: Part 11 enables digital GxP documentation with data integrity, accountability and traceability. The requirements shape validated eBR, MES and quality systems, but they do not replace the GMP requirements of the applicable predicate rules.
Core requirements (excerpt):
- System validation for the intended use.
- Controlled access rights and unique user identities.
- Time-stamped audit trails for relevant changes.
- Electronic signatures with identity, time, meaning and record binding.
Distinction: Part 11 does not make a system compliant on its own. Compliance results from implementation, validation, procedures, training and controlled operation.
Short version: 21 CFR Part 11 defines when ER/ES are defensible and acceptable in FDA-regulated environments.
Further reading: