The challenge
A biopharmaceutical company needed its SAP S/4HANA ERP system to meet GxP requirements and 21 CFR Part 11. Data integrity and regulatory compliance depended on it.
The system had to be validated and then monitored to stay compliant. Implementation and operational risks had to be found and reduced.
The company also needed audit-ready validation documents, control over CAPA, quality metrics and project tracking, and coordination of a validation team spread across time zones.
Our approach
- Led computer system validation (CSV) and oversaw the system's validated state.
- Ran GxP assessments, wrote validation plans and set functional risk strategies.
- Prepared and reviewed validation documents and protocols.
- Ran CAPA processes, tracked quality metrics and monitored project progress.
- Managed the globally distributed validation team.
Results
- Better regulatory compliance for the ERP system.
- More efficient validation and compliance processes.
- Stronger quality assurance and proactive risk management.
- Effective collaboration across the global team.