Many of these processes are highly regulated by governmental guidelines such as the FDA’s 21 CFR Part 11 and the EU’s Annex 11. As such, the processes and tools used need to be validated and businesses are subject to regular audits from the various regional authorities.
GCI PowerTools Suite in Life Sciences Use Case
OpenText Content Suite is used by many organizations within the Life Sciences (Pharmaceutical, Biotech, Diagnostic, Medical Devices) industry for managing the documents and processes related to clinical trials, new drug development / discovery and manufacturing.