E
erikam
I work for a small clinical lab (aprox 20 lab techs) who has previously been subjected to CLIA rather than FDA regulations. As such, we have not validated our LIMS (Lab info management system) which tracks and creates our patient reports. My company recently decided to start accepting samples for pharmaceutical companies for clinical trial purposes, so I am implementing GCP for the lab. Obviously, we need to get our old (but still in use) LIMS validated, as well as the new one which is currently being debugged, and not yet iimplemented. The new system does have electronic signatures and is suposidly complient. I was not here when the decision was made to purchase the software.
My background is in QA and Regulatory Affairs not IT, and I'm not sure how to go about getting this validation accomplished. Is this something we can hire a consultant to do for us, or is it something the IT manager who is implementing the LIMS should be doing?
Thanks is advance, this area of software validtion is new to me and to my company and I really appreciate any guidence any of you have.
My background is in QA and Regulatory Affairs not IT, and I'm not sure how to go about getting this validation accomplished. Is this something we can hire a consultant to do for us, or is it something the IT manager who is implementing the LIMS should be doing?
Thanks is advance, this area of software validtion is new to me and to my company and I really appreciate any guidence any of you have.