For anyone running a paper based Quality Management System, and especially the controlled document management side of life, you know the massive amount of forms and trackers needed to control the life cycle of a document and quality event. A bi-yearly document set review would generate well over 300 separate files for me to fill, distribute, and manage! For document management, I got rid of all my forms for change control because the system takes care of that simply by how it's designed.
The system is also intuitive to use and the support team is very helpful, even sending complex questions to the dev team for input. I was able to get over the new-system learning curve by playing around in the sandbox and referencing the detailed help center. Review collected by and hosted on G2.com.
Unfortunately as an academic/hospital type institution we have hundreds of individuals involved in regulated clinical trials, with a high turnover rate. Because of the seat-based fee structure, it wasn't feasible to allow everyone into the system and instead just the core QA team uses it. This does necessitate a hybrid approach for event management and document release and training, but the efficiencies gained in the QA team well make up for it. Review collected by and hosted on G2.com.
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