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Biotech Startup Companies: How to Take on the Pharma Giants and Win

Dubbed the 'combination of money and molecules', Biotech is a famously hard sector in which to find and fund s...

5 min read

5 Challenges in Building a Pharmacovigilance System Master File

Managing the integrity and accessibility of a PSMF (Pharmacovigilance System Master File) is a key challenge f...

5 min read

Making the Switch: Transforming Your TMF into an eTMF

A Trial Master File (TMF) is a comprehensive collection of documents that ensures the conduct of your clinical...

4 min read

Effective GxP Compliance: Managing Change Control for Safety

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

4 min read

Demystifying FDA 21 CFR Part 820: A Comprehensive Guide

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

5 min read

Best Practices for Good Documentation in Regulated Industries

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

4 min read

8 Essential GMP Principles for Med Tech Developers

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

4 min read

Cognidox v10.1: New Features for FDA Compliance in Med Tech

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

2 min read

Understanding Electronic Signatures in Med-Tech eQMS

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

4 min read

Navigating the Challenges of Covid-19 Vaccine Distribution

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 Enhances GxP Compliance in Med-Tech

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

2 min read

GMP Compliance: The 5 Pillars of Pharmaceutical Sector Quality

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

2 min read

Understanding GMP vs cGMP in Life Science Manufacturing

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

3 min read

Understanding cGxP: Ensuring Quality in Life Science Industry

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

4 min read