21 CFR Part 11

21 CFR Part 11 is the FDA regulation that defines the criteria for electronic records and signatures to be considered equivalent to paper records and signatures. For any pharma site exporting to the United States, its compliance is non-negotiable. We implement it on automation and MES systems with four pillars: electronic signatures linked to identity (password + unique identifier, or biometrics), tamper-evident audit trail recording who did what and when on critical data, strict user account control (provisioning, deactivation, periodic review of rights), and protection against unauthorized modification or deletion of records. 21 CFR Part 11 validation must be architected from the FDS, never added at the end of a project, at the risk of heavy refactoring and FDA audit exposure.