I am a physician in a medical laboratory doing both commercial and clinical trials (FDA regulated) diagnostic studies on a global basis. We are redesigning our entire validation, documentation and training systems and I am in the process of using MOODLE to manage the training process. I have a very computer savvy employee who used to be the administrator for the ANGEL LMS from Indiana Universiy (that is now a commercial product).
Now here is the delimma, everything even remotely associated with Clinical trials and even routine medicine is getting extremely regulated and we virtually are inspected 12+ times a year (1-4 day audits). With Part11 regulations ALL software (developed or off the shelf) has to have a full system validation. The FDA has moved this to a risk-based processes, so intense validation is in basically critical data where users have access to alter data. We develop our own LIS (Laboratory Information System) because you cannot get OTS software with functionality to work in clinical trials. Thus we have a small team of (pharmaceutical business experienced) validation personnel. So we will do something in this area. However it would be extremely helpful if others had done some of this work to share some use case examples and any outcomes or known areas of system weakness. The FDA is also very strongly into electronic audit trails, is that possible in MOODLE?
Since I am new to this software, I am just starting to explore it, but would welcome any experience in this area. We will sure share our experience with others becuase this type of software has a much broader application that just in educational institutions. (I was also the medical director of a fully ACCME accredited non-profit post-graduate medical education company that had over 5,000 medical technologist and physician subscribers. That company was sold to the largest CME provider for laboratory professionals in the world, ASCP).
Mick Glant, MD Indianapolis, IN