Your client's company is in a regulated industries and must keep detailed records of their...

When implementing Oracle E-Signatures and E-Records for compliance with 21 CFR Part 11 in regulated industries like the pharmaceutical or food industries, certain processes govern how electronic records and signatures are managed for manufacturing work orders. The statement thatis not trueis:

Statement B is incorrectbecause when using deferred electronic records and signatures, the work order isnot held in a "Released" status until approvals are obtained. Instead, the work order is placed in a "Pending Approval" state until signatures are collected and approval is granted. Only after approval does the work order move to a "Released" status.

Correct statements:

Statement A: E-records are generated at the time of work order release, and notifications are sent to approvers for review.

Statement C: Rejected e-records can be resubmitted for approval if necessary.

Statement D: These capabilities are supported for both discrete and process manufacturing work orders.