Implementing 21 CFR Part 11 in Cosmetics

$$item.publishDate) | Contact Author | By: Richard Balano and Lenore Coyle, NOVA Technology Corp.
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Title: Implementing 21 CFR Part 11 in Cosmetics
regulatory affairsx electronic recordsx electronic signaturesx FDA-compliant data filesx testingx
  • Article

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.

Excerpt Only This is a shortened version or summary of the article that appeared in the Nov. 1, 2004 issue of Cosmetics & Toiletries magazine. The full content is not currently available online.