To help ensure compliance with the US Code of Federal Regulations (21 CFR Part 11), your client wants to enable audit trail for manufacturing work definitions and standard operations. Which is NOT included in the audit trail for standard operations such as creation, update, and deletion?
Correct Answer: C
When enabling audit trail functionality to ensure compliance with the US Code of Federal Regulations (21 CFR Part 11), certain actions related to work definitions and standard operations are audited for changes such as creation, update, and deletion. However, not all aspects are tracked in the audit trail. Item structure component attributes referenced from Product Information Management (PIM) are not included in the audit trail. PIM attributes are managed separately from manufacturing-specific data, and changes to these components are not captured in the standard operations audit trail. Audited components typically include: Work definition header and version attributes Descriptive flexfields (DFFs) at any level Attachments at any level Operation resources, including alternate resources
