Medidata’s Statement on FDA ERES 2024 Guidance

Medidata Statement on the release of the US Food and Drug Administration’s Final guidance,  Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers Guidance for Industry. October 2024, Procedural, Revision 1

On October 2, 2024, the U.S. Food and Drug Administration (FDA) released the final version of its Guidance on the use of Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations of Medical Products (“2024 Guidance”). The 2024 Guidance provides non-binding recommendations regarding the requirements under 21 CFR part 11, under which  FDA considers electronic systems, electronic records, and electronic signatures to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. The 2024 Guidance finalizes the draft guidance for industry issued in March 2023, titled Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11–Questions and Answers (“2023 Guidance”). The 2024 Guidance also supersedes the May 2007 guidance for industry titled Computerized Systems Used in Clinical Investigations.

Medidata has been following developments with this guidance and commented to the FDA on the 2023 Guidance. As with the 2023 Guidance and prior issued guidelines, the FDA “continues to apply a narrow and practical interpretation of the part 11 regulations…” and mentions risk-based approaches to computerized system validation.

We welcome the opportunity to review the final guidance and are actively engaged with internal stakeholders to ensure our compliance. We will issue a position paper detailing our compliance posture in the coming weeks to our clients and external stakeholders which will be posted on the Medidata Trust and Transparency page.