The Premier
Laboratory Informatics Experts

21 CFR part 11: 20 Years Later – SQA 2018

Author: John Zenk
Presentation Time: 30 min Podium Presentation
Category: Computer Validation
When: Session BB, April 11th, 2018 at 3:30pm-5:00pm
Where: Platinum 3&4

In August of 1997 the FDA released 21 CFR part 11 to the industry.  The regulation was met with confusion as to exactly what it meant, who was responsible for the compliance (vendors or end users), and how to make every computer system compliant.  The FDA then released guidance documents, the industry grasped on to legacy systems, and software developers started incorporating part 11 compliance functionality.  And then came the Scope and Guidance in 2003 and there was light at the end of the tunnel.  Fast forward to today; where we have come since the beginning?  How has technology changed?  Do we know what it all means,or are there still questions to ask?  And now with cloud systems, virtual employees, and everything going digital, do we know who is responsible for all those records? Are we any closer to compliance than we were in 1997?

Key Take-Aways:

  • Understand where part 11 has taken the industry
  • Learn how technology has adapted to the regulations
  • Discover different approaches for how companies have complied with the regulation
  • See how you can leverage experience and industry knowledge to be compliant

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