FDA Part 11 New Draft (March 2023) Guidance

By Sara Saunders, Policy Manager at Florence Healthcare

In March, the FDA posted a new draft guidance on Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations to provide additional recommendations regarding the requirements under 21 CFR Part 11. When in effect, this guidance will revise the 2017 draft guidance on Use of Electronic Records and Electronic Signatures, expand upon the 2003 Part 11 guidance, and supersede the 2007 Guidance on Computerized Systems Used in Clinical Investigations. Below is a high level summary of how the FDA’s updated guidance addresses the use of technology in clinical trials:

Electronic Records

  • Applicability of Part 11 to real-world data sources, electronic communications and clinical investigations with foreign sites
  • Alignment with ICH GCP E6 (R2) on usage of certified copies when a copy is intended to have the same information (including metadata) as the original

Electronic Systems Owned or Controlled by Sponsors or Other Regulated Entities

  • Recommendations for electronic systems (such as eTMF and eConsent) that are owned or controlled by regulated entities and used to produce required records in clinical investigations
  • Considerations and documentation for applying a risk-based approach to validation of electronic systems
  • FDA’s focus during inspections of the sponsor and/or clinical investigator site, including audit documentation of IT service providers for electronic systems
  • Recommendations for security safeguards (e.g. firewalls, encryption) and access controls (e.g. multi-factor authentication, biometrics) to meet Part 11 requirements
  • Audit trail requirements to record changes and recommendations around the decision of when to review audit trails

Information Technology Service Providers and Services

  • Considerations when choosing an IT service provider to ensure the authenticity, integrity, and confidentiality of data
  • Recommendations surrounding the written agreements that sponsors and other regulated entities should have with IT service providers

Digital Health Technologies

  • Applicability of the Digital Health Technologies for Remote Data Acquisition in Clinical Investigations to Part 11 requirements 
  • Identification of a data originator when recording record changes

Electronic Signatures

  • Examples of methods to confirm the user’s identity when creating electronic signatures in line with Part 11
  • Requirements for an electronic signature based on biometrics to be considered acceptable under Part 11

Florence has submitted comments on the current draft guidance, and intends to fully conform with the recommendations in this guidance by its effectiveness. If you have any questions, you can submit online or written comments to the FDA on this guidance at any time.

Looking for more information on Clinical Trial Regulations? Check out these Florence resources: