Support organizations in finding a balance between automated systems and regulations.
Compliance Solutions Designed by Compliance Professionals for Compliance Professionals
We offer an integrated portfolio of consultancy services and software products for ensuring GxP compliance of business processes and the used resources, including facilities, utilities, equipment and IT. Furthermore, we offer IT services and solutions to establish and maintain a GxP-compliant and reliable IT infrastructure and application landscape for continuous business operations. Our portfolio provides a full solution for ensuring permanent inspection readiness in an efficient way. Moreover, our software products enable paperless validation and compliance.
Your company has just been inspected by the US Food and Drug Administration (FDA) Office and the FDA inspectors handed over an FDA Form 483 at the end of the inspection. What does that mean for your c...
“I hear and I forget; I see and I remember;
I do and I understand”
- Confucius -
This course is based on the above quote of Confucius.
Why you should attend?
Following a practical case of developing a...
The European Parliament and the Council have reached an agreement in June 2016 for better surveillance and traceability of medical and in vitro diagnostic devices after the negotiation of comments and...