Did it take your company a lot of time to break into that market? Is there a lot business that is outsourced? Or is it more staff augmentation? Also, is it all software testing, or is it also process and load testing?
Interesting... So, when you finish your analysis, you would then probably either hire tester with Part 11 experience, or staff augment your team with Part 11 people... Or would you simply outsource a Part 11 validation project to a testing firm that has experience? I am just trying to see the trend of how pharma companies usually staff these projects... Just curious, do you have a preferred list of Part 11 compliant vendors?
I have just started work at a company that is required to be complaint with 21 CFR Part 11. I do not believe Part 11 is very specific on the requirements and as such, we are producing "tons" of documentation. I have worked many DoD, FAA and other Government Procurement Projects and we are producing much more paper than any Project I have ever been on. We test off the shelf (vendor developed)software. Every time a different set of varibles or configuration data is used, we go through a full validation effort including screen shots of every step of the process. Now getting ready to deactivate some older data bases. This has been turned into a Project including testing. I guess I have a lot to learn in this business. 30 + years in the software/system development business and I have never seen anything like this.