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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In February 2015, the US FDA released a draft guidance on the repackaging of certain products by pharmacies and outsourcing facilities.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...

New FDA Initiatives Launched

  • Saturday, December 13, 2014

The FDA has announced two new initiatives, one aimed at addressing medical device quality beyond compliance and the other allowing firms to voluntarily self-identify and correct possible regulatory violations instead of un...

Searching for Engineers - Quality over Quantity

  • Monday, December 1, 2014

The Irish life science industry is currently one of the sectors leading Ireland towards economic recovery. Regular news reports feature announcements from the Irish government on new jobs, expansion of facilities and new m...

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Recent Posts

Continual Improvement Process

  • Thursday, March 28, 2019

Reducing Validation Costs – What’s the Most Effective Way?

  • Tuesday, June 5, 2018

Got the interview? Now time to get the job!

  • Wednesday, March 7, 2018

Establishing a Successful Data Integrity Management Culture

  • Tuesday, August 29, 2017

Is Over Regulation Stifling Innovation?

  • Wednesday, April 19, 2017

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