Validation life cycle concurrent

The steps in the validation life cycle are not necessarily executed in the order indicated. Rather, the steps are usually executed as an iterative process in which various functions may be carried out concurrently. If necessary, steps may be repeated. For instance, the Validation Master Plan may be developed after, or concurrently with, the User Requirements Specification (URS) rather than before, as indicated. Equally, a Supplier Audit often involves a series of steps that may not be complete until well into the validation project. 

The validation life cycle adopted shonld be cnstomized for each individnal project. Often there are opportunities for vations phases to be carried ont concurrently. However, the phases must be clearly defined in advance, with acceptance criteria and appropriate verification to ensure that each phase is completed in a state of control. This must be specified and docnmented in the Validation Plan. The following chapters examine in detail the activities associated with the life cycle ontlined... 

Concurrent validation is conducted under a protocol during the course of normal production. The first three production-scale batches must be monitored as comprehensively as possible. The evaluation of the results is used in establishing the acceptance criteria and specifications of subsequent in-process control and final product testing. Some form of concurrent validation, using statistical process control techniques (quality control charting), may be used throughout the product manufacturing life cycle. 

These tests, along with all other validation activities, may be summarized in an overall computer system Validation Plan (VP) which is prepared early in the system development life cycle (often concurrent with the system-detailed user requirements definition). 

The life cycle for concurrent validation is divided into the following steps (Figure 2.3) ... 

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