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Abstract

Are the records maintained in a computerized system subject to 21 CFR 11? Does 21 CFR 11 apply to a computerized system that is only used for “administrative/tracking” functions? Is an e-mail of an electronic record subject to 21 CFR 11?

We often lose sight of the fact that answers to these types of questions depend on underlying predicate regulations and internal policies. 21 CFR 11 does not stand alone; record and signature requirements flow from current Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and the Quality System Regulation (collectively referred to as GxP). A company's internal policies, as well as the behaviors of system end users, also influence, and potentially expand, the scope and applicability of 21 CFR 11. This article provides an overview of key record and signature provisions in GxP; the role of internal policies in defining identification and maintenance of regulated records and signature requirements; and the potential impact of computerized system end user behavior when utilizing general purpose applications such as e-mail.

Keywords

Predicate regulation Internal policies Scope E-mail System end user 21 CFR 11 Part 11

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References

US Food and Drug Administration Risk-Based Initiative. US Food and Drug Administration Web site. Available at www.fda.gov/cder/gmp/index.htm. Accessed April 4, 2003.

US Food and Drug Administration withdrawal of guidance documents on Part 11. US Food and Drug Administration Web site. Available at www.fda.gov/cder/gmp/cd0314.pdf. Accessed April 4, 2003.

US Food and Drug Administration Draft Guidance on the Scope and Application of Part 11. US Food and Drug Administration Web site. Available at www.fda.gov/cder/guidance/5055dft.PDF. Accessed April 4, 2003.

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Health Insurance Portability and Accountability Act Primer. Health and Human Services Center for Medicare and Medicaid Web site. Available at www.cms.hhs.gov/hipaa/hipaa2/default.asp. Accessed April 4, 2003.

21 CFR Part 11: The Role of Predicate Regulations and Associated Internal Policies

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