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Would your business benefit from using electronic signatures within your digital quality management system (eQ...
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Would your business benefit from using electronic signatures within your digital quality management system (eQ...
Dubbed the 'combination of money and molecules', Biotech is a famously hard sector in which to find and fund s...
Managing the integrity and accessibility of a PSMF (Pharmacovigilance System Master File) is a key challenge f...
A Trial Master File (TMF) is a comprehensive collection of documents that ensures the conduct of your clinical...
Change control in life science development is critical to ensuring the safety of patients. Having a formal pro...
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...
Cambridge, UK, 18th Jan 2021: Cognidox, a leading provider of document management solutions for the medical de...
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...
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