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J ust what is "21 CFR Part 11"? Do I need to consider it when designing lab automation software? Sure, I store data electronically, but my "official" copy is a signed hardcopy stored in my documentation control system, so Part 11 doesn't apply to me, right? These and similar questions are being asked with increasing frequency during the development process for both off-the-shelf and custom lab automation software. This article presents a brief overview of the FDA regulation concerning the use of electronic records and electronic signatures and a guide for software analysts and developers. REGULATION OVERVIEW Records are kept for a number of reasons. 21 CFR Part 11 (Part 11) 1 applies only to those records "that persons create, modify, maintain, archive, retrieve, or transmit under any records or signature requirement set forth in the Federal Food, Drug, and Cosmetic Act (the Act), the Public Health Service Act (PHS Act), or any FDA regulation. Any requirements set forth in the Act, the PHS Act, or any FDA regulation, with the exception of part 11, are referred to ... as predicate rules." 3 Traditionally these records have been paper-based and stored in files or binders. When those records required signatures, the document was distributed to all parties on the signature list, and the signatures were stored along with the original.

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