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Life-Sciences eQMS 20 items

21 CFR Part 11 Electronic Records & Signatures Compliance Checklist

Assesses whether a computerized system meets FDA requirements for trustworthy electronic records and legally binding electronic signatures. Use for closed/open system qualification and periodic review.

21 CFR Part 11FDA Part 11 Scope & Application Guidance

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System Validation and Scope

  • Is the system validated to ensure accuracy, reliability, and consistent intended performance? *
  • Is the system classified as closed or open, with controls appropriate to that classification? *
  • Can the system generate accurate and complete copies of records in human-readable and electronic form for inspection? *

Audit Trail

  • Does the system use secure, computer-generated, time-stamped audit trails for create, modify, and delete actions? *
  • Are audit trails retained for at least as long as the underlying records and available for review and copying? *
  • Is the audit trail protected so it cannot be disabled or edited by users? *
  • Are audit trails reviewed as part of the record review process? *

Access Control and Security

  • Is system access limited to authorized individuals via unique credentials? *
  • Are authority checks in place to ensure only authorized users can perform specific operations? *
  • Are device/terminal checks used where appropriate to verify data source validity?
  • Are password policies (length, complexity, expiry, lockout) enforced? *

Electronic Signatures

  • Does each electronic signature contain the printed name, date/time, and meaning of the signing? *
  • Are electronic signatures linked to their records so they cannot be excised, copied, or transferred? *
  • For non-biometric signatures, do they use at least two distinct identification components (e.g., user ID and password)? *
  • Has a certification been submitted to FDA that electronic signatures are the legally binding equivalent of handwritten signatures? *

Data Retention and Backup

  • Are electronic records retained and retrievable throughout the required retention period? *
  • Are routine backups performed and periodically verified by restore testing? *
  • Record the date of the last successful backup restore verification.

Training and SOPs

  • Are persons who develop, maintain, or use the system trained to perform their assigned tasks? *
  • Are there written policies holding individuals accountable for actions taken under their electronic signatures? *

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