I’m new to the area of Computer Systems Validation (qualified microbiologist!) and the company I work for are not well versed on the topic either. I have through research managed to self educate myself on the whole regulatory aspects and guideline documents out there on the validation of Computer systems 21 CFR part 11 and predictive rules, Annex 11 of the Eu GMP, PIC/s guidelines CEFIC guidelines GAMP 5 etc, and I am well aware that “risk assessment” is the Buzz word of the whole approach taken.
I am the validation lead on site to manage the successful Validation of an electronic webbased Quality Management system called trackwise. I am wondering if anybody could share there approach/experiences in the validation of sush a system?
Additionally my company has purchased the IQ OQ package from the vendor, however due to the budget constraints of such a small company they have little funds to enable a constant link back to the vendor specialists on issues. additionaly we do not have an IT department on site.
If anybody could share their experiences it would be really appreciated