Validation Center

AI & CGMP: FDA's 1st Warning Letter on Non-Compliant AI in Manufacturing

Validation Center — Thu, 23 Apr 2026 04:00:00 GMT

The FDA’s April 2026 Warning Letter to Purolea Cosmetics Lab is a notable milestone for the pharmaceutical industry. While there have been prior Warning Letters involving products that incorporate AI, this case may represent one of the first enforcement actions specifically citing the use of AI itself in pharmaceutical manufacturing operations as non-compliant.

How Mature Is Your Data Integrity? New FDA and EU Regulatory Focus Areas

Validation Center — Thu, 23 Oct 2025 04:00:00 GMT

Data integrity has been in regulators’ spotlight for decades, and the expectations for ensuring data integrity are evolving and increasing. This is partly because of the various Data Integrity guidance documents that have been issued, but primarily due to the increasing number of inspection findings involving data integrity, reliability, and trustworthiness. Having a proper data lifecycle and data management program in place requires a mature governance data framework.

Why is Computer System Validation Required? What Happens if You Don’t Comply?

Rodrigo Perez — Mon, 06 Jan 2025 05:00:00 GMT

Computer system and software validation is about the patients and the products we make for the patients. As consumers we want to trust that our medicine, medical devices, instruments our doctors use, and so forth, work the way we expect them to work.

Digital Transformation in CSV - How to implement Digital Validation?

Esra Guven — Fri, 22 Nov 2024 05:00:00 GMT

The FDA encourages a risk-based approach and critical thinking in Computer Systems Validation and promotes efficiency. Using digital validation tools and adopting paperless validation helps not only meet FDA regulations but also promotes efficiency, consistency, and audit readiness.

How to Audit Software Vendors: Execution - Validation Center

Deb Bartel — Wed, 23 Oct 2024 04:00:00 GMT

Welcome to Part 2 of our series on how to audit software vendors. We will focus on the main event – doing the inspection! Before you go any further, make sure you have read How to Audit Software Vendors: Part 1 – Audit Preparation. It goes into detail about what you should be doing to get ready for the audit itself.

Are you ready for the FDA guidance on Data Integrity and Compliance?

Deb Bartel — Mon, 23 Sep 2024 04:00:00 GMT

The FDA just published a new, draft guidance document on good manufacturing practices (cGMP) for drugs. This document is intended to address the frequent data integrity issues found during FDA inspection of pharmaceutical and API manufacturing sites.

3 Reasons for Auditing Software Vendors - Validation Center

Deb Bartel — Mon, 06 Jul 2020 04:00:00 GMT

Regulatory Agencies, like the FDA and Eudralex require companies to audit software vendors of their critical software and systems. Regulated companies include several industries – Pharmaceuticals, Biologics, Medical Devices, Clinical Studies, and Blood Products – and include organizations that sell in both the US and International markets.

8 Regulatory Expectations for Purchased Systems - Validation Center

Deb Bartel — Fri, 17 Aug 2018 05:00:00 GMT

If you have purchased or are planning to purchase a computer system for use in regulated activities, here are some key points to keep in mind. As the regulated company, your responsibilities differ from those of your vendor. There are examples from multiple regulatory documents regarding cloud and SaaS computer systems.

Sponsoring & Speaking at 2018 MWSQA Annual Conference

Validation Center — Sun, 17 Jun 2018 05:00:00 GMT

We are thrilled to announce another speaking opportunity for Deb Bartel this summer. She will be speaking at the Midwest Regional Chapter Society of Quality Assurance Annual Conference during July 24-25th.

4 Types of Software Requiring Validation, 5 Regulatory Expectations

Rodrigo Perez — Wed, 25 Apr 2018 05:00:00 GMT

Companies who are are new to computer system validation often ask us whether software validation is required for their specific software or systems. And they often assume that they must validate their entire system. While that assumption makes perfect sense, it is not always correct. More on that in a bit. But first, we must understand what types of systems require validation.