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FDA Warning Letters provide a useful view into the compliance problems the agency considers serious enough to require formal corrective...
For nearly two decades, ICH Q9 has been the backbone of pharmaceutical quality risk management (QRM). Adopted in 2005, it...
Almost nothing that goes into a finished product is made entirely in-house; raw materials, components, contract manufacturing, testing laboratories, calibration...
A practical buyer’s guide for evaluating electronic quality management systems. Ten questions to ask every vendor, and how ACE by...
Blood banks operate in a tightly regulated life sciences environment. In the United States, the FDA enforces 21 CFR Part...
Choosing an electronic quality management system is rarely just a software decision. For pharmaceutical, biotech, and medical device teams, it...
Singapore has become a closely watched regulator in digital health. In March 2026, the country’s Ministry of Health (MOH) and...
What is an Electronic Signature? An electronic signature, or e-signature, is any electronic process attached to or logically associated with...
On January 14, 2026, the U.S. Food and Drug Administration and the European Medicines Agency jointly released the Guiding Principles...
One question we hear from teams evaluating an electronic quality management system (eQMS) is deceptively simple: can a record’s lifecycle...
The time it takes to make and release a batch of product factors in raw material dispensing, processing time, packaging,...
In an earlier post, we looked at how ICH E6(R3) is pushing Good Clinical Practice from being prescriptive and site-based...
The most common summary of the Digital Omnibus on AI is that the EU delayed the AI Act, but that...
A CDMO sponsor sends a change request for a procedure, and meanwhile the CDMO site updates the affected procedure and...
Mergers and acquisitions, while demanding financial and commercial events, also provide a unique challenge for quality organizations. When two companies...
Supplier and vendor oversight is one of the heavier lifts in a modern quality operation. Every new vendor requires a...
Most software vendors are now including AI in their packages; some promise autonomous digital co-workers while others market agentic assistants...
What is Data Hygiene Data hygiene is the ongoing practice of keeping data accurate, complete, consistent, and current across its...
