Our quality team has started down the path of GxP (21 CFR Part 11) compliant access control/compliance. They have a single catalog Item for new, change existing or terminate a user which initiates new or changes to each of the 12 GxP controlled applications.
They require the original record to maintain cradle-to-grave linkage from the original NEW request to maintain a record of all subsequent changes and a termination if appropriate.
We are trying to 'write back' the subsequent changes/term to the origina REQ. Then they decided they wanted to be able to print this for an FDA auditor all in 1 go with customized output.
Context: We have ITSM pro, ITOM.
Question:
once we have the original request built we are trying to write back subsequent change/term RITM to the original REQ. (Is there a better way?)
They also want a customized PDF output that includes all the variable sets from each application showing user original access, edit, edit, edit (etc.), terminate if exists.
