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Electronic vs Digital Signatures: Are You Compliant?

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

6 min read

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

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

4 min read

FDA 21 CFR Part 820 Explained: QSR Requirements & Guide

If you’re developing or manufacturing medical devices in the U.S., complying with FDA 21 CFR Part 820—also kno...

6 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

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

GMP vs cGMP: Understanding Compliance 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