Conduct GxP Audit

Plan and execute a GxP audit of computerized systems, data integrity practices, or regulated processes.

When to Use

• Scheduled internal audit of a validated computerized system
• Supplier/vendor qualification audit for GxP-relevant software
• Pre-inspection readiness assessment before a regulatory audit
• For-cause audit triggered by a deviation, complaint, or data integrity concern
• Periodic review of a validated system's compliance posture

Inputs

• Required: Audit scope (system, process, or site to audit)
• Required: Applicable regulations (21 CFR Part 11, EU Annex 11, GMP, GLP, GCP)
• Required: Previous audit reports and open CAPA items
• Optional: System validation documentation (URS, VP, IQ/OQ/PQ, traceability matrix)
• Optional: SOPs, training records, change control logs