as of 2019 - 10 - 24

7.D Validation documentation

7.D Validation documentation
Here you will find answers to the following questions:

What documents have to be created for a validation?

What is the purpose of a traceability matrix?

Where and for how long do validation documents have to be archived?

What is the purpose of a validation master plan?

What are the main elements of a validation master plan?

What does a validation matrix contain?

What is meant by bracketing and matrixing?

Under what circumstances can product families (product groups) be validated collectively?

What specifications and requirements does a validation protocol contain?

What does a test plan contain?

How are meaningful acceptance criteria established?

What procedure is followed when changes to the validation protocol are required during the actual validation?

How is a validation batch defined during continuous manufacturing?

What does a validation report contain?

What process has to be followed when deviations from the requirements in the validation protocol are detected during the evaluation?

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