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System Qualification Validation according to GAMP & Data Integrity

In many industries qualification and validation is defined as the documented evidence that a procedure, process and activity will consistently lead to the expected results. It often contains the qualification and validation of systems (as equipment, instrument, computer, utility, etc.). It is a requirement for Good Manufacturing Practices (GMP) and other GxP regulated industries.
Important other requlation in relation to the validation of (computerized) systems is defined in the title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) and Anex 11 of the European Medicines Agency (EMA).

Qualification or Validation according to FDA's is "Establishing Documented Evidence that provides a high degree of assurance that will consistently producing a process specifies a product meeting its pre-determined specifications and quality attributes." (FDA 1987). A properly designed system will ensure a high level of assurance that each step, process and change is well assessed before the implementation takes place. Testing a sample of a finished product alone is not regarded as sufficient evidence that any product within a party meets the required specifications. Validation is also related to automated systems. The ISPE GAMP®5 Guide a risk-based approach to compliant GxP Systems, published in February 2008 and currently 2nd edition (2022), provides pragmatic and practical approach for the industry to ensure that systems are suitable for the intended use in an efficient and effective manner.

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