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FDA draft guidance on Data Integrity – 18 Questions & Answers

Apr 17, 2016 | 2 Comments

On April 14th 2016 U.S. Food and Drug Administration published a draft guidance for comments on Data Integrity: Data Integrity and Compliance With Current Good Manufacturing Practice Guidance for Industry. The draft guidance is a question & answer document, raising 18 questions regarding data integrity and provides FDA’s current thinking about the role of data integrity in current good manufacturing practice (CGMP) for drugs,…

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EU-GMP New Annex 16: The 6 most important points

Apr 14, 2016 | 0 Comments

The European Commission has prepared the revision of Annex 16 to the EU Guidelines for Good Manufacturing Practice for Medicinal Products „Certification by a Qualified Person and Batch Release“.
Coming into operation as of 15th April 2016, every GMP expert should be informed what matters in the new Annex 16.…

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5 good reasons to upgrade or replace your Pharma MES!

Mar 29, 2016 | 0 Comments

MES emergency call – How the topic came up

A couple of years ago I received an emergency call from one of our clients: “Hey Thomas, I just got a message from IT who told me that they will no longer support our current IT infrastructure for MES!…

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5 years HGP: A reason to celebrate!

Jan 9, 2015 | 0 Comments

We invite you to celebrate our anniversary with us.
Why the company almost didn’t survive the first year and how you will get to the virtual anniversary party, please read here.…

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