VAL019 Gudiance on Validation Activities for Systems at Low-, Moderate-, and High-Risk Levels (RiskVal^SM)

When a Validation Master Plan is created, information is gathered about the computer systems in use. Based on the information collected about a system, a determination is made as to whether or not that system needs to be validated, and validation priorities are set for all of the systems. This document provides a form and instructions for collecting information regarding a computerized system: its intended uses, the consequences of its failure, and the quality records created. Based on that information, reviewers complete the form by determining a risk level for both regulatory issues and business issues, if Part 11 applies, if validation is needed, and the priority for validation.

Here the term “Validation Master Plan” refers to a plan for the validation of all computerized systems at a facility.

The template for creating a validation plan for a specific system is called a Validation Plan. A template for such a plan, the “Validation Plan Template for Single System Validations” is also available at this website.