21 CFR Part 11 checklist

• Each user has a unique ID; accounts are not shared
• Passwords expire and lock after failed attempts
• Electronic signatures include printed name, date/time and meaning
• Signature manifestations cannot be excised from the record
• Secure, computer-generated, time-stamped audit trail of create/modify/delete
• Audit trail is retained as long as the record and cannot be altered
• Operational system checks enforce permitted sequencing of steps
• Authority checks limit access to authorized individuals
• Device checks (where used) determine validity of the data source
• Open systems have additional encryption / digital-signature controls
• Records can be copied in a human-readable and electronic form for inspection
• Backup, disaster recovery and retention period are documented

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0 of 12 controls marked present. Gaps belong in the validation / Part 11 assessment, not in a marketing slide.