Must-Have Components of a Validation Plan
A successful validation effort relies on a strong Validation Plan (VP). This crucial document defines the goals and deliverables for success, including how to create the objective evidence you need to ensure product quality, patient safety, and regulatory compliance.
Here are the essential components of a comprehensive VP:
Document controls: Including those outlined in Good Documentation Practices, such as title, version/dates, author, and reviewer/approvers.
Introduction and purpose: A paragraph about the computerized system being implemented and the validation intent.
System overview: An overview of the computerized system being implemented, including software vendor, integrations, etc.
Validation scope, strategy, and testing approach: Where the validation starts and ends, if it includes migrations or integrations, description of the testing approach, and risk-based management.
Roles and responsibilities: Who is responsible for authoring/reviewing/approving each document?
References to standards, guidelines, and other applicable documents: 21 CFR Part 11/Annex 11, any predicate rules/regulations, internal SOPs, etc.
Glossary and abbreviations: A comprehensive list of all abbreviations in the document.
Training: UAT tester training, system training, and user documentation.
How to handle testing errors: E.g., document the deviation, consider the requirement that was being tested and its criticality, and resolve and retest.
List of SOP/SOI/WIs to be created/updated: Including system support, access controls, user management, system use, change controls, etc.
System acceptance criteria: What needs to be completed before the move to production, including where the validation document will be stored, who owns the document, required status of SOP/SOI/WIs, and who signs off on the system.
A comprehensive validation plan is essential for ensuring that systems, processes, and equipment in regulated industries meet regulatory standards and function as intended. This not only ensures compliance but also enhances product quality and patient safety, ultimately contributing to the success and credibility of the company in the marketplace.