Implement Audit Trail

Add audit trail capabilities to R projects for regulatory compliance.

When to Use

• R analysis requires electronic records compliance (21 CFR Part 11)
• Need to track who did what, when, and why in an analysis
• Implementing data provenance tracking
• Creating tamper-evident analysis logs

Inputs

• Required: R project with data processing or analysis scripts
• Required: Regulatory requirements (which audit trail elements are mandatory)
• Optional: Existing logging infrastructure
• Optional: Electronic signature requirements

Procedure