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The Importance of Effective Root Cause Analysis

  • Wednesday, March 23, 2016

For many years, we’ve been conducting remediation projects for organizations of different sizes from around the world. From our experience, one of the most common causes of regulatory issues is one that can be addressed in...

The Life Science Industry in 2016 – what lies ahead?

  • Tuesday, January 5, 2016

As we look back on 2015, we can see that the life science industry was dramatically altered worldwide. Aging population, lifestyle changes, advances in technology and the emergence of new markets in developing countries al...

Serialization, Entropy and the Law of Conservation of Mass - Part 1

  • Thursday, October 29, 2015

Driving home from a Serialization conference, I started to think about Entropy and the randomness of serialized numbers. In the EU Directive 2011/62, the unique identifying numbers must be random, non-sequential and unique...

Engineering consultants - 5 benefits when choosing contract engineers

  • Monday, May 18, 2015

During the course of our week, GxP Systems get a number of requests for short term contract engineers; they could be working on projects that can last from 4 weeks to 12 months. It’s not just Validation engineers in demand...

Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities

  • Thursday, April 2, 2015

In February 2015, the US FDA released a draft guidance on the repackaging of certain products by pharmacies and outsourcing facilities. The closing date for comment was set for 17.05.2015, but when the actual guidance is e...

Program Management: some useful tips

  • Monday, March 9, 2015

I’ve been working in the life science industry for the last 10 years, in engineering roles at different levels. For the last number of years, I’ve been managing the validation program at a site where GxP Systems has a long...

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