Consulting

BIOMEDION have been consultants for computer system validation and 21 CFR part 11 compliance since 2001.

We have many years experience in project implementation, in both small and medium-sized enterprises, and also in pharmaceutical multinationals

Computer system validation with GAMP5
You need to introduce a validated IT system? We know the challenges from a variety of different projects and can advise you on the effective GAMP5-compliant documentation of your project from validation plan to validation report.

21 CFR part 11 for Beginners
You are new to 21 CFR part 11? We can inform you within the scope of an all-day workshop and together we can sketch the way to achieving compliance. 
This workshop is also suitable for software developers who design software for the pharmaceutical industry.

Roadmap to Compliance
The statutory requirements for IT organisation are diverse and wide ranging. Meeting these requirements is not just a question of acquiring a particular software.

BIOMEDION advises its’ clients in project preparation and implementation with the goal of the comprehensive fulfilment of these requirements as regards the IT organisation, the software used and its configuration, and also the implementation and documentation of user training.