Global Process Manager also deploys ready-to-go Processes and packaged sets of changes to DELMIA Apriso production servers. It is therefore essential for it to require users to sign their work using e-signatures when deploying data while working in a CFR-Part-11-regulated environment.
21-CFR-Part-11 can be configured using the keys located in the "DeploymentServices" section of the Central Configuration file (for details, see Central Configuration Documentation).
The system requires a sign-off when a package (with any type of content) is being deployed on a server which requires such a sign-off. Packages (Package Actions) deployed in a CFR-Part-11-regulated environment have an additional Signature tab in their Properties that allows the viewing of signature details. Below is a screenshot of the approval screen displayed when a package is deployed in a 21-CFR-Part-11-regulated environment:
To learn more about 21-CFR-Part-11, consult the 21-CFR-Part-11 Compliance Implementation Guide. To learn more about Processes and Operations, refer to the Process Builder Help.