Validation life cycle prospective

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

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 process for implementation and prospective validation of computer systems outlined in Figure 3 depicts the system application activities within each life-cycle phase and identifies key issues and considerations for each step. The process includes for evaluation of both the computer system product and the system supplier s working methods. The same life-cycle approach may be applied to validate the associated control and monitoring instrumentation [9]. 

The results were a joint FDA/PMA Conference in 1984 diseussing computer validation and, 2 years later, the publieation of an industry perspective. The publieation presented a life-cycle approach for validating both new and existing computer systems. Guidanee on existing systems was required beeause the FDA expected both existing and new computer systems to be brought into hne with its expeetations for validation, and its requirements were not limited to just prospective validation of new eomputer systems. 

The final staffing life-cycle phase is entitled maintenance and covers the prospective validation of new computer system systems and periodic revalidation of current computer systems. This phase is typically managed in-house, using work packages contracted to suppliers. At this stage, a set of... 

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 prospective validation is divided into the following steps (Figure 2.1) ... 

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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