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John Robinson's Blog – June 2016 Archive (1)
Effective Steps for Validation and 21 CFR Part 11 Compliance (CSV)
If one were to define validation; it can be considered the deed of testing an item or system for the level or extent to which it complies with a standard that it has to show compliance with.
In the case of computer systems, validation is a major requirement for these regulatory bodies/practices:
o The US FDA
o European Medicines Agency (EMA)
o Good Manufacturing Practices (GMP)
o Good Laboratory Practices (GLP)
o Good Clinical Practices (GCP)
o All the… Continue
In the case of computer systems, validation is a major requirement for these regulatory bodies/practices:
o The US FDA
o European Medicines Agency (EMA)
o Good Manufacturing Practices (GMP)
o Good Laboratory Practices (GLP)
o Good Clinical Practices (GCP)
o All the… Continue
Added by John Robinson on June 6, 2016 at 2:33am — No Comments
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