CSV Validation Planning

One of the first and most important steps in Computer System Validation (CSV) is Validation Planning. In this exercise, the validation team must determine the scope of the activity, including what must be validated and who does what.

Regulated companies are required to have a formal CSV policy or procedure describing on a high level the roles and responsibilities, the activities and deliverables and the format and criteria under which different types of computer systems can be considered fit for their intended uses. If this policy is not already in place, then Validation Planning will help to shape it.

Validation Master Plan

A Validation Master Plan should list all computer systems of a whole business unit, site or the entire company. Each system should be defined for risk classification, its reference within the validation plan, the next due validation date and the main stakeholders for that system.

CSV Roadmap

Based on the outcomes of the initial assessments (see Resources), the validation plan sets forth the approach to validate a computer system to provide the team with a roadmap for the whole process. This plan should include the purpose and scope, a system overview, and the detailed roles and responsibilities for each member of the CSV team.

The planning should provide a detailed description of the validation process and its expected deliverables. It should also define the criteria for system release and approval, any risk considerations and what are the supporting processes for change control, documentation and training.

Building on sound foundations

The Validation Plan should be relatively straightforward since it is essentially building on foundations already established in the Initial Assessment Phase. Provided the right effort has been put into the initial collaborations and consultations with stakeholders and subject matter experts during the assessment, it should by now be clear what the purpose and scope of the CSV exercise will be, and what will be involved.

So, the Validation Planning is essentially there to give this knowledge some shape and turn it into an Action Plan and timeline.

Successful Validation Planning opens the way for the detailed work to begin, starting with Risk Management, which will be described by the next article in his series.

Resources

Click on CSV Fundamentals: Validation Planning to read original blog article .
Click on CSV Initial Assessment to read previous article.

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