We are a small company looking for a solution that meets Part 11 security requirements. Has anyone accomplished this? I know a lot of pharmaceutical companies have done this. I am strong user and intermediate administrator but I have not been involved with setting it up (and documenting) in a way to meet these requirements. To start, do we need to purchase the Premium version or will the Standard version suffice? What add-ons are you using? How are you documenting that JIRA is compliant with the regulations.
