Re: Implementing a fully electronical QMS-system. Input needed/wanted
No, I am not associated with Master Control. I work for a Medical Equipment company here in upstate NY called Lucid Inc. (We manufacture a confocal microscope used for the imaging of the skin at a cellular level in real time. The advantage to confocal is it can also penetrate the skin down to 200um-300um. Think of it as a digital biopsy. No cutting involved)
Anyway, we need a document system which would follow the FDA requirements for signature approvals. During an FDA audit in 2002, the auditor did not like the email authorization we had been using. We looked around and found Master Control (at the time, it was the least costly system we could find at around $30K). It is much more than a document vault, but that is all we are using it for right now. It controls who can view and check out documents, revision control, access to draft or archived revisions, retention, review, so on...
It also has additional modules for CAPA, training, Forms, Reports, etc.