Article | October 27, 2023

Halloran's Feedback On FDA's Electronic Systems, Records, And Signatures Guidance

By Sheila Gwizdak, Dana Macdonald, PMP, Karen Travers, Mike Lynch And Lina Duarte


The Clinical Operations Retreat for Executives (CORE West) recently brought together leaders in the life sciences sector to explore the modernization of clinical trials. One discussion regarding the U.S. Food and Drug Administration's (FDA) latest draft guidance was noted to capture the audience's attention through an interactive workshop.

The discussed draft guidance furnishes recommendations regarding the stipulations found in Title 21 CFR Part 11 (CFR part 11), which delineates how the FDA evaluates electronic systems, electronic records, and electronic signatures to ensure they are trustworthy, reliable, and generally equivalent to conventional paper records and handwritten signatures. According to reports, this framework has not seen substantial updates for quite some time. While several updates have been published since 1997, the latest draft guidance addresses the continuing relevance of part 11, as it affects how technological advancements continue to impact the industry.

Specifically, the updated guidance explores various facets, including information technology (IT), service providers, clinical investigator sites, digital health technologies (DHTs), and real-world data (RWD). The impact of this guidance extends to a wide array of stakeholders involved in clinical trials, encompassing product developers, sponsors, sites, patients, and technology vendors.

Access the article below for a summary of industry feedback received during this interactive workshop at CORE West. Halloran notes that this feedback will be shared with the FDA to ensure that the final guidance benefits from industry insights and offers greater clarity.

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