Latest News & Updates

Insightful content from our thought leaders

Join our subscribers

Receive instant blog updates, straight to your inbox

Managing the change control process for GxP compliance

Change control in life science development is critical to ensuring the safety of patients. Having a formal pro...

4 min read

QSR Compliance: What’s inside FDA 21 CFR Part 820?

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

5 min read

What are good documentation practices & how can they best be implemented?

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

4 min read

8 GMP principles for med tech developers to live by

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

4 min read

Cognidox v10.1 delivers new features for FDA compliance

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

2 min read

Electronic VS Digital Signatures? What do you need for a med-tech eQMS?

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

5 min read

Precious Cargo: Covid-19 Vaccines and Good Distribution Practice (GDP)

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

3 min read

9 ways QMS software helps you maintain & demonstrate GxP compliance

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

2 min read

The 5 Pillars of GMP in the Pharmaceutical Sector

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

2 min read

GMP v cGMP. What's the difference?

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

3 min read

What Is cGxP?

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

4 min read