We have a long history of helping pharma, biotech and medical device companies meet both regulatory and business needs. We accomplish this through the implementation of SAP EAM and adoption of our Asset Management Framework (AMF) best practices.
Our focus on the Life Sciences industry is further illustrated by the investment and development of our QMC. This is a calibration solution that reduces inherent complexities and offers additional flexible functionalities to create a seamless process for the maintenance organization.
Meet rigorous compliance requirements
Master data management
Calibration and configuration management
Supporting good clinical, laboratory and manufacturing guidelines (GxP)
Addressing regulations such as 21 CFR Part 11 for the management of electronic records (e.g. audit trails, electronic signatures).
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Returning from SAP Field Kick-Off Meeting (FKOM) in Barcelona, Achim shares some insights from the event.Read more