Computer System Validation (CSV) for 503B Quality System

Client Type

503B outsourcing facility implementing an electronic QMS platform for batch records, deviation handling, and CAPA tracking

The Challenge

The facility was migrating from a paper-based QMS to an electronic system. They needed to validate the new platform according to 21 CFR Part 11, GAMP 5 principles, and FDA guidance for data integrity—without disrupting production.

Our Solution

Restore Health Consulting led a structured CSV effort:

  • Developed a risk-based validation plan and trace matrix

  • Drafted and executed Installation, Operational, and Performance Qualification (IQ/OQ/PQ)

  • Verified audit trails, access controls, e-signature functions, and backup protocols

  • Delivered validation summary report and SOP updates for system use

The Outcome

✔ The system was validated and released for GMP use
✔ All functions met Part 11 compliance requirements
✔ Internal users were trained, and procedures were harmonized with paper-based legacy records

“Restore made CSV feel manageable—even during a complex system rollout. We had what we needed to show inspectors from day one.”