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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...
Understand when to validate, when to verify, and how to maintain process control throughout the medical device lifecycle. This playbook...
Few operations in life sciences carry more regulatory weight than a blood bank. The units of biologic product collected, tested,...
Out-of-specification investigations are one of the most inspected processes in a pharmaceutical lab, and consistently one of the most cited....
Most quality teams don’t suddenly decide that their eQMS needs to be replaced. This is an important decision that is...
The FDA released Draft Guidance Quality Management System Information for Certain Premarket Submission Reviews in October 2025 to prepare medical...
Most quality teams know that manual inspection prep is inefficient, but what’s harder to define is exactly how inefficient it...
What the RWE Program Is The Advancing Real-World Evidence (RWE) Program is an optional, sponsor-initiated pathway run by the Center...
The teams behind the development and design of an eQMS platform are just as important as the features suite. Successful...
Company Background BioNTech is a global biotechnology leader known for advancing scientific innovation in immunotherapies, vaccines, and personalized medicine. They...
Unannounced inspections are becoming more frequent across regulatory agencies. In May 2025, the FDA formally announced the expansion of its...
Leaders in life sciences organizations know that PTO requests come in waves, especially in the summer and every winter holiday...
An eQMS doesn’t always have to start as a fully configurable platform. Most organizations begin with a focused system that...
FDA inspections can put documentation, quality systems, training records, CAPAs, and data integrity under close review. This is a practical...
