We are upgrading our quality system to one “portal” or “centre”, where all our quality related data and procedures will be contained e.g. customer complaints & improvements, docuemnts(including forms,validation documents, SOPs), equipment information, supplier information, all audit details & schedules, training, links to other systems etc. Our new quailty system will also allow for electronic sign off. At the moment we are using an electronic and paper based system (it is not part 11 compliant, so everything on the system is for info purposes only, and the biggest waste of money spent on a system!!) so you can image the amount of paper work that goes with, our paper records are our quality records, and we have all the usual issues that go with paper records. It is going to be a massive enterprise system, customised to out own needs of course!
Mmmmm that sounds like a bit of a pain…we are actually using Kneat (
) to house all of our Quality System which also allows us to execute all our validation online plus a million other things. The best thing about this platform is that it has been designed specifically for the life sciences so it has all of the requirements for Part 11 and Annex 11 built in…unlike Quality Center which does not…as you are seeing now.
The Kneat guys actually have all of the necessary validation documentation for the system so we used that and had it qualified in a week. We also have access to their QMS and SDLC so we could leverage what we wanted.
Also there is no customisation involved its all configurable…big difference!
Not sure how I can help you really you have a big project ahead.