Validation life cycle retrospective

The extent of validation necessary will depend on a number of factors, including the use to which the system is to be put, whether the validation is to be prospective or retrospective, and whether novel elements are incorporated. Validation should be considered as part of the complete life cycle of a computer system. This cycle... 

For new applications or projects a prospective validation based on a recognized life cycle is the most effective and efficient approach. The life-cycle methodology can also be adapted for existing systems that do not have adequate documented records to support a retrospective validation. 

The cost and complexity of validation is often underestimated and can cause delays in bringing the product to market. Validation requirements for a project should be identified as early as possible in the project life cycle to ensure that adequate time and cost is allowed to complete them successfully. It is particularly important to establish the documentation required from suppliers and contractors working on the project, and the extent to which they will be required to play a part in the validation process. For example, if material certification is required for equipment components, these must be ordered from the supplier s own stockholders with the raw materials, and cannot be obtained retrospectively. 

Now that the kind of validation that we are going to perform on our system is defined — prospective or retrospective — it is necessary to clarify the scope of the system. Agreeing that the scope is extremely important for two reasons. First, we can adopt the appropriate variant of the V-Model life cycle, depending on the use of different categories of software. Second, it makes it possible to establish what is part of our system and what is not part of our system — substantially, what we are going to validate and what we do not validate. 

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

Validation of computerized systems differs from the validation processes previously described because of the complexity and key-function in the process controls of such systems. Therefore, computer validation has a special life cycle (system development life cycle [SDLC]) that contains the hardware and the software. The sub-sections of the SDLC are similar to the subsections of the life cycles for prospective/retrospective validation processes. 

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