MedPharm: GxP Compliance System

The Challenge

Pharmaceutical manufacturing required a validated, audit-ready maintenance system meeting FDA 21 CFR Part 11 — electronic records, signatures, and full traceability.

Our Approach

• Defined validation scope and authored qualification protocols (IQ/OQ/PQ)
• Configured the maintenance system for electronic signatures and audit trails
• Established controlled change management for GxP-relevant configuration
• Trained quality and maintenance teams on compliant work execution

Results

• Validated maintenance system meeting 21 CFR Part 11
• 100% PM compliance on GxP-critical equipment
• 99.9% uptime on validated production assets