IT Project Management: A Validation Challenge

Changing Project Management Methodology From Traditional to Agile PM

Computer systems validation is a procedure performed in every pharmaceutical or medical device company that uses IT systems at the stage of production, logistics or distribution of its products.

Join our MDR webinar!

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In cooperation with our Swiss Partner – Luzern Baar Consulting, we’re delighted to invite you to attend our exclusive webinar session: New reality after MDR implementation – what can you expect?

Important Announcement

With a great sense of sadness and loss, we received the news that 23.05.2021 our CEO – Mr Paweł Dębski passed away.

Who, when and how should prepare for the amendment of Annex 1?

Team of Scientists in Sterile Protective Clothing Work on a Modern Industrial 3D Printing Machinery. Pharmaceutical, Biotechnological and Semiconductor Creating / Manufacturing Process.

The pharmaceutical industry is characterised by numerous requirements governing its functioning. In my professional history, I have yet to meet an employee of this industry, who couldn’t wait to see an amendment to the Good Manufacturing Practice (GMP) requirements.