Going through out TS audit, revamping our lab scope, all the good stuff. Has anyone ever been asked about their software per the TS standard? I was asked in the mid 90's under a different audit format, but nothing since. I found PCDMIS is NIST certified, but not Datapage? Hexagon promotes Datapage compliant to FDA Part 11. I submitted a ticket, Hexagon is reviewing the issue. I was just wondering if anyone has been through the software portion of the audit? I was also told that the certification must be at least annual, even if the software proved out in the past by Hexagon. I can understand the proving out in case of possible issues over time. How have you proved the software is proper, if you have?
Odda
