1. Validation and 21 CFR Part 11 Compliance

2. 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.

3. In the case of computer systems, validation is a major requirement for these regulatory bodies/practices:
The US FDA
European Medicines Agency (EMA)
Good Manufacturing Practices (GMP)
Good Laboratory Practices (GLP)
Good Clinical Practices (GCP)
All the Predicate Rules

4. Interesting, right?
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