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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...
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...
How to Audit Software Vendors: Part 1 - Audit Preparation
October 10, 2017Welcome to our three part series on how to audit software vendors. In part one, we’ll review the basic processes and pre...
Warning Letter Roundup - January 2017
January 12, 2017The FDA sends Warning Letters and 483s to companies who significantly violate FDA regulations. We gather those related t...
23 Data Integrity FAQs Answered By The EMA
September 22, 2016Last month, the EMA’s Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Inspectors Working Group publ...