Validation Center
Computer System Validation News
AI & CGMP: FDA's 1st Warning Letter on Non-Compliant AI in Manufacturing
April 23, 2026The FDA’s April 2026 Warning Letter to Purolea Cosmetics Lab is a notable milestone for the pharmaceutical industry. Whi...
How Mature Is Your Data Integrity? New FDA and EU Regulatory Focus Areas
October 23, 2025Data integrity has been in regulators’ spotlight for decades, and the expectations for ensuring data integrity are evolv...
Why is Computer System Validation Required? What Happens if You Don’t Comply?
January 06, 2025Computer system and software validation is about the patients and the products we make for the patients. As consumers we...
Digital Transformation in CSV - How to implement Digital Validation?
November 22, 2024The FDA encourages a risk-based approach and critical thinking in Computer Systems Validation and promotes efficiency. U...
How to Audit Software Vendors: Execution
October 23, 2024Welcome to Part 2 of our series on how to audit software vendors. We will focus on the main event – doing the inspection...
Are you ready for the FDA guidance on Data Integrity and Compliance?
September 23, 2024The FDA just published a new, draft guidance document on good manufacturing practices (cGMP) for drugs. This document is...
3 Reasons for Auditing Software Vendors
July 06, 2020Regulatory Agencies, like the FDA and Eudralex require companies to audit software vendors of their critical software an...
8 Regulatory Expectations for Purchased Systems
August 17, 2018If you have purchased or are planning to purchase a computer system for use in regulated activities, here are some key p...
Sponsoring & Speaking at 2018 MWSQA Annual Conference
June 17, 2018We are thrilled to announce another speaking opportunity for Deb Bartel this summer. She will be speaking at the Midwest...
4 Types of Software Requiring Validation, 5 Regulatory Expectations
April 25, 2018Companies who are are new to computer system validation often ask us whether software validation is required for their s...