The Paperless Chase: Regulatory Bane or Productivity Boon?
- Topics:
- Pharmeceuticals
- Source:
- Pharma Manufacturing
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Overview: After years of prodding from the pharmaceutical industry, the U.S. Food and Drug Administration (FDA) published its final rule on 21 CFR Part 11, covering electronic documents and signatures, on March 20, 1997. FDA came up with 21 CFR Part 11 in response to industry's request for regulatory guidance on how to use electronic documents and signatures. With mergers, generics and patent expirations pressuring pharmaceutical manufacturers to become more efficient, Part 11 compliance needs to become part of that success formula. This paper points out that complying with Part 11 allow managers to concentrate on operational efficiency that much sooner, and in a compliant manner.
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