Hi,
Apparently, SAS is (see here) but I couldn't find a clear statement about JMP. Is it the software itself that can be GMP compliant, or is it a workflow, or specific capabilities? Anyone know?
Hadley
Before starting at JMP about a year and half ago, I was an industry consultant for pharm. manufacturing for SAS HLS. The statement that SAS is GMP compliant is broad statement that can be misinterpreted and needs explanation. There is one solution within the SAS Life Science Analytics Framework that is GMP compliant. It has been used for clinical data and reporting for many years and provides Part 11 compliant features such as management of users, version control, and audit history. There has been a more recent effort to extend its use into commercial manufacturing. See this paper we wrote up. However, this solution is limited in the type and amount of SAS products that can be used. Most notably, you can only use programming for generating static reports. I could go on and on, but I will sum up by saying that SAS Visual Analytics on Viya is just as GMP compliant as JMP.
You can certainly build out GMP-compliant workflows in JMP. It is important to understand (and convince the Quality department) that you validate the workflow (ie, the script) using a version of JMP that has gone through IQ, OQ. As Chris mentioned in the post that Phil shared, I used Predictum to help take the workflow we built and build out the computer system validation of the scripts - IQ, OQ, and PQ protocols and reports.
Hi @HadleyMyers ,
Variations on this question come up on a regular basis. I had a customer this week asking the same.
See this thread for the best response from @Jeff_Perkinson .
Cheers,
Phil
