I have been given a great opportunity to create, implement and design as robust QMS for a non-profit clinical trials organisation. I have create a 12-18 month action plan which will evolve and adapt as time goes on. I am open to ideas and suggestions from other QA professionals. It's like a QA Dream to create their ultimate QMS. Please note I am in Australia so some of the rules and regs are vastly different (mind boggling tbh) to the the rest of the world, but I can still tailor and adapt to this setting.
Currently on high on the list is
SOPs redesigned - user friendly
Vendor Management Program
Training Management System
QC and Controlled documentation
Really starting from scratch.
It would be greatly appreciated if I could hear everyone's suggestions on their ideal QMS.
Look forward to hearing from you all,