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Open Access

Software Recalls – Issues and Challenges

by Wallace, Jeme;

Software Recalls, Risk Assessment
How to deal with software recalls for medical devices...

  • Filetype: pdf
  • Publish date: 2010-04
  • Keywords:Software, recalls, FDA, EU, Canadian Regulations
Open Access

American Society for Quality Meeting the Compliance Challenge

by Jay, James;

The key to meeting your compliance challenge is understanding the role and effective implementation of CAPA...

  • Filetype: pdf
  • Publish date: 2010-04
  • Keywords:compliance, CAPA, software

Disaster Recovery & Business Continuity--Related, but NOT the Same

by Teri Stokes

FDC GMP Conference, 2009

  • Filetype: pdf
  • Publish date: 2009-07
  • Keywords:Disaster Recovery, Part 11, Software

End User Testing for Performance Qualification of GXP/Part 11 Systems-Off The Shelf (OTS)

by Teri Stokes

FDC GMP Conference, 2009..

  • Filetype: pdf
  • Publish date: 2009-07
  • Keywords:Part 11, COTS, Software, PQ testing

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