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In addition to Good Manufacturing Practices, supply chain oversight, labeling, registrations, listings, adverse event tracking and all the other regulatory requirements required by FDA, use of electronic records and submissions adds an additional compliance requirement – 21 CFR 11 except for records required by FSMA.

Whenever documentation such as SOPs, change control logs, manifests, etc are held in any kind of digital or electronic format, FDA requires the same type of record keeping as with paper records, including signatures, notations and time and date stamps. However, in order to ensure the trustworthiness, reliability and equivalency of those electronic documents, and additional verification through compliance with 21 CFR 11 must be demonstrated.

How do companies demonstrate compliance to FDA? Through eight (8) specific documents that verify electronic records and signatures have been appropriately designed and are utilized:

  1. Validation Master Plan (VMP)
  2. Functional Requirements Specification (FRS)
  3. System Design Specification (SDS)
  4. Installation Qualification (IQ)
  5. Operational Qualification (OQ)
  6. Performance Qualification (PQ)
  7. Requirements Traceablility Matrix (RTM)
  8. Validation Summary Report (VSR)

Do your electronic records meet FDA’s requirements under 21 CFR 11?

EAS offers compliance checks and electronic records protocol design to ensure when FDA knocks on your door, you’ll be ready. Contact us to discuss your electronic records systems, to schedule a review or to redesign or refresh your current structure. Whether as part of a GMP review, supplier verification audit or as part of your next FDA submission, compliance with 21 CFR 11 ensures the highest standards of electronic integrity.

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