Concept of a Validation Life Cycle

2 CONCEPT OF A VALIDATION LIFE CYCLE 2.2.1 Prospective Validation Life Cycle 

Establishing documented evidence prior to process implementation that a system does what it proposed to do based on preplanned protocols. 

Each prospective validation step will be described in Qualification/Validation documents. In these documents, except for the Validation Master Plan and the Validation Report, the test methods for validation and acceptance criteria for the results are specified. Also described are whether the equipment has to be prepared for the test method and whether the original status of the equipment has to be restored after testing. 

The life cycle for retrospective validation is divided into the following steps  

Actual survey of facilities, processes, and process controls 

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When I wrote this in 1993,1 had hoped to define validation in terms of how it was to be accomplished. I also introduced the concept of a validation life cycle (see later section) as the appropriate means by which to manage its... 

Concept of a validation life cycle Elements of validation... 

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