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Fundamentals of Computerized Systems Validation (CSV)

Validation Planning

Quality Assurance - CSV - Software Validation

This is the third one in a series of posts on general aspects of Computerized Systems Validation (CSV). In this post we will be looking at the validation planning.

Validation Policies

Regulated companies should have a computer systems validation 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 intended use.

Validation Master Plan

A Validation Master Plan should list all computer systems of a whole business unit, site or the entire company with, for each system, the risk classification, a reference to the validation plan, the next validation date and the main stakeholders.

Validation Plan

Based on the outcomes of the initial assessments, the validation plan sets forth the approach to validate a computer system. This plan should include the purpose and scope, a system overview, the roles and responsibilities, a detailed description of the process and the expected deliverables, the criteria for release, any risk considerations and what are the supporting processes for change control, documentation and training.


The Validation Plan should be relatively straight forward considering that the right effort has been put into the initial assessments in collaboration with stakeholders and subject matter experts and that there is a common understanding of the purpose and scope. Contact us for a free first consultation session.

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