On July 8, the Food and Drug Administration (FDA) announced an initiative “… to evaluate industry’s compliance and understanding of Part 11 in light of the enforcement discretion described in the August 2003 Guidance for Industry Part 11, Electronic Records; Electronic Signatures—Scope and Application. (See the FDA announcement for details.)

What does this mean for pharmaceutical and medical device manufacturers?

First and foremost, the announcement means there is no time like now to reexamine how your company’s methods for creating, archiving, retrieving, and controlling data can potentially affect your products’ quality.

For example, many pharmaceutical companies should examine whether their data systems for controlled-environment monitoring provide full data accessibility (e.g., reports on raw data, necessary statistics, and graphs, whether generated automatically or on demand) and ensure tamper-proof content.

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