Implementing 21 CFR Part 11 in Cosmetics

December 18, 2005 | Contact Author | By: Richard Balano and Lenore Coyle, NOVA Technology Corp.
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Keywords: regulatory affairs | electronic records | electronic signatures | FDA-compliant data files | testing

Abstract: 21 CFR Part 11 specifies the comprehensive set of administrative, procedural and technical controls that must be implemented when data files, records and signatures are created, maintained or archived in an electronic format as part of a program to comply with FDA rules. In the cosmetics industry, specific applications are in development and testing of OTC drugs and color additives.

As increasing amounts of correspondence, data and analysis are created and stored on computers, paperless records have become part of the normal procedure in cosmetic and personal care R&D. How can regulatory authorities be sure that these paperless records are authentic? Each company should take the steps described here to protect the authenticity of its paperless records.

In 1991, members of the pharmaceutical industry met with the United Stated Food and Drug Administration (FDA) to determine how they could accommodate a paperless record system under Good Manufacturing Practices, or GMP. In 1992, the FDA published a proposed rule concerning the use of electronic identification/signatures and requested comments on that proposed rule. In 1997, FDA published 21 CFR Part 11 to define the criteria under which FDA considers electronic records to be equivalent to paper records and electronic signatures equivalent to traditional handwritten signatures. Industry now refers to the rules established for electronic records and electronic signatures simply as “Part 11,” referring to the eleventh part.

Companies everywhere began scrambling to determine if the new rules applied to their activities and if so, how to implement them. The manufacturers of medical instrumentation, as well as suppliers to those companies were now asking and fielding questions like, “Is your software Part 11 compliant?” Instrument and software suppliers to FDAregulated industries suddenly had to redesign their products in order to fulfill their customers’ needs.