21 CFR Part 11

Electronic Signatures for FDA Submissions

Regardless of the type of industry you are, if you are regulated by the FDA you are bound by the rules around electronic data integrity. Whether preparing to release a finished batch of material, making decisions on data and information that was created and generated electronically or preparing to file a technical dossier with the FDA; your electronic recordkeeping and other electronic data forms require more than just being available for review and inspection. The FDA requires these sources of evidence to be generated, processed and maintained in a manner that provides complete traceability, prevents unauthorized alteration and requires a verified electronic signature that ensures identity and authenticity. 

Compliance with Title 21, Part 11 of the Code of Federal Regulations; Electronic Records; Electronic Signaturesis inclusive of a larger focus on Good Manufacturing Practices and applies to all records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations, and in addition, those electronic records submitted to the Agency under the Federal Food, Drug, and Cosmetic Act (FD&C) and the Public Health Service Act (PHS), even if such records are not specifically identified in Agency regulations.

FDA exercises enforcement discretion with regards to part 11 requirements for validation, audit trails, record retention, and record copying as part of a holistic Quality System that includes Software Development Life Cycle (SDLC) Governance validation, audit trails, records and retention policies which must preserve content and meaning.

As FDA began requiring electronic submissions of applications such as Drug Master Files, (DMF), New Drug Applications (NDAs), Device 510(k) applications and amendments to, electronic signatures are required for all packets submitted to FDA regardless of whether electronic records are kept internally.

EAS assists firms with ensuring understanding of compliance requirements under 21 CFR 11, including a thorough review of SOPs and validation plans that assess Design Specifications (ICS/FRS/DDS), System Specification Procedures, Installation Qualification, Operation Qualification, Performance Qualification (IQ OQ PQ) studies, as well as a detailed traceability matrix which ultimately enables production of a Validation Summary Report.

If you would like additional information or discuss how EAS can help your firm please contact us!