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Software Recalls – Issues and Challenges
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

American Society for Quality Meeting the Compliance Challenge
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
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)
FDC GMP Conference, 2009..
- Filetype: pdf
- Publish date: 2009-07
- Keywords:Part 11, COTS, Software, PQ testing