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FDA draft guidance on Data Integrity – 18 Questions & Answers

Apr 17, 2016 |

On April 14th 2016 U.S. Food and Drug Administration published a draft guidance for comments on Data Integrity: Data Integrity and Compliance With Current Good Manufacturing Practice Guidance for Industry. The draft guidance is a question & answer document, raising 18 questions regarding data integrity and provides FDA’s current thinking about the role of data integrity in current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

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 |

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 |

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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