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The FDA’s Quality System Regulation (QSR) for medical device manufacturers is commonly known as FDA 21 CFR Par...

Good documentation practices (also known as GdocP or GDP) are guidelines for document management and control d...

Good Manufacturing Practices (GMP) are intended to ensure that pharmaceutical products, medical devices and ot...

Change control in life science development is critical to ensuring the ultimate safety of end users. And havin...

Cambridge, UK, 18th Jan 2021: Cognidox, a leading provider of document management solutions for the medical de...

Would your business benefit from using electronic signatures within your digital quality management system (eQ...

The race for the development of a Covid-19 vaccine has been an incredible story of fast tracked innovation. Th...

Throughout the med-tech regulatory literature quality systems are cited as the way GxP (current best practice)...

For pharmaceutical and other life science disciplines, the ‘5Ps of GMP’ are a useful way of thinking about the...

GMP is part of the best practice guidelines (GxP) which the FDA and other official bodies refer to in their re...

cGxP (also known simply as GxP) is an acronym used by the FDA and other regulators within the life science ind...