The US Food and Drug Administration has published final guidance, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers, clarifying how 21 CFR Part 11 applies to modern clinical trials.
Key points
- A risk-based approach to validating electronic systems is encouraged.
- The guidance covers IT service providers, including cloud computing services and digital health technologies.
- Sponsors should have agreements with service providers that address data security, access and audit trails.
- Electronic signature and audit trail expectations are clarified.
UK organisations supplying software, hosting or data services for clinical trials submitted to the FDA should review their validation evidence and customer agreements.
Source: Electronic Systems, Records and Signatures in Clinical Investigations guidance (FDA)
Need help understanding what this change means for your organisation? Get in touch for a pragmatic, no-obligation conversation.
