Electronic Systems, Records, and Signatures in Clinical Investigations: Questions and Answers

In October 2024, FDA issued a final guidance document entitled “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers.” It outlines requirements under 21 C.F.R. Part 11 as applicable to FDA-regulated medical device and other clinical trials, offering recommendations to help ensure utilized electronic methods are trustworthy, reliable, and comparable to paper records and handwritten signatures. The final guidance builds on recommendations from the 2003 FDA draft guidance document.

Taking advantage of 21 C.F.R. Part 11 brings specific challenges that demand robust electronic systems capable of ensuring data integrity, security, and traceability. Selecting the right tools for capturing and managing electronic clinical trial data are critical. Relying on tools that fall short of these standards can jeopardize not only your FDA compliance status but also the reliability and trustworthiness of the data itself.

Standard Microsoft Excel does not comply with 21 C.F.R. Part 11.  It lacks necessary features like audit trails, electronic signatures, robust security, and protection against data manipulation.  Consequently, it cannot adequately manage electronic records to meet the Part 11 requirements.

Validated electronic data capture (EDC) systems, compliant with 21 C.F.R. Part 11, are specifically designed to address the stringent requirements of FDA-regulated clinical investigations. Organizations can choose from a wide range of EDC systems, each catering to different operational needs and budgets. Options range from cloud-based platforms with subscription pricing models to on-premises solutions with one-time licensing fees. Many providers also offer scalable systems that can grow with the scope of a clinical investigation, allowing flexibility for smaller trials and large-scale studies alike. Selecting the right EDC system involves evaluating functionality, regulatory compliance, and cost-effectiveness to ensure optimal alignment with the specific goals of the clinical investigation.

Here is a link to the FDA final guidance document.