21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

  • 545.00 Dollar US$
  • Published date: July 3, 2019
    • Fremont, California, United States

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.
While many of these are intended to streamline operations, reducing time and resources, some unintentionally result in added layers of oversight that encumber a computer system validation program and require more time and resources, making the technology unattractive from a cost-benefit perspective.

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John Robinson
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