[ THE CHALLENGE ]
Managing Validation at a Global Scale
Before GoVal, Sai Life Sciences faced the complexities of managing manual validation processes across multiple international sites. Their paper-based system created several significant challenges for a dynamic, multi-site CMO:
- Inconsistent Processes: Ensuring validation procedures were harmonized across all sites in India and the UK was a constant operational challenge.
- Manual Inefficiencies: The entire validation lifecycle was labor-intensive, slow, and prone to human error, from drafting protocols to routing documents for physical signatures.
- Lack of Real-Time Visibility: Tracking project status and identifying bottlenecks required manual data compilation, hindering global quality oversight.
- Compliance and Audit Risks: Managing physical documentation for audits was cumbersome and posed a significant risk to data integrity and audit readiness.
