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Last update:2012.04.04.
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Where are you now? Intelligence Services > Validation > Validation


We may say that validation is the foundation of CGMP. The regulatory life cycle for validation requirements can be compared to a quality improvement spiral; as we move upward in the spiral, the truthfulness of CGMP is approached (however, it may be never reached, if it is ever reached, then we do not need the FDA). Our Web-site will include information, regulation, case-studies, and knowledge on:

  • Process validation,
  • Water system validation,
  • Methods validation,
  • Cleaning validation,
  • Computer system validation,
  • Software validation,
  • Competency training validation,
  • 21 CFR Part 11 validation,
  • DQ-IQ-OQ-PQ.

It has been estimated that the industry spends over $50 billion a year on validation, that is on converging to true CGMP. If we look at the Warning Letter statistics, we may wonder where did all that money go?

We intend to dissect and analyze the anatomy of validation and try to understand the problems we all face.

21 CFR Part 11 Issues
Various aspects of electronic records and electronic signatures
Forum Database
Almost 100,000 searchable messages from 16 working newsgroups. Updated regularly.
Warning Letters Knowledge Base
An extremely versatile database that will assist familiarization with the regulatory requirements
Competency Trainings & Exams
Multimedia enriched learning materials, exercises and exams.
On-line Trainings & Exams
Web-based learning materials, exercises and exams

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