Our signature solution has undergone validation according to the Hamilton QM system. This is aligned with Good Automated Manufacturing Practice 5 (GAMP 5) and ensures that the signature solution is operated in compliance with the pharmaceutical industry requirements of CFR 21 Part 820 Chapters 70 & 75, the ISO 13485 standard as well as the EU MDR and IVDR regulations.
Validation includes comprehensive testing of all aspects of the signature solution, including features, performance and security. Our signature solution has been tested by experienced and qualified validation experts and with the help of external subject matter experts to ensure that it meets all the requirements.