Skip to main content

Sai Life Sciences' Global Leap:

Achieving Harmonized Validation Across 10+ Sites with GoVal

As a leading global CRO-CMO, Sai Life Sciences partnered with GoVal to digitize and standardize their Computer System Validation processes across all sites in India and the UK, driving efficiency and global compliance.

Talk to Our Consultant
Sai Life Sciences Global Harmonization

[ 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.

[ THE SOLUTION ]

A Unified, Workflow-Driven Validation Platform

Sai Life Sciences chose GoVal's paperless software to create a single source of truth for all CSV activities. The goal was to implement a robust, workflow-based system that could be standardized across all 10+ sites, providing flexibility while enforcing a consistent quality standard. GoVal's platform provided an end-to-end solution, transforming their manual processes into a fully automated, digital ecosystem.

Custom CSV Templates

GoVal empowered Sai Life's teams to design and enforce standardized templates, ensuring every validation project followed a consistent structure.

Automated Workflows

Physical document movement was replaced with an automated workflow engine, using e-signatures to accelerate review and approval cycles.

Automated Reporting

The manual effort of compiling RTM and VSR documents was eliminated, with GoVal generating live, comprehensive reports with a single click.

[ THE OUTCOME ]

A Harmonized, Efficient, and Audit-Ready Global Operation

  • Global Harmonization: Sai Life now operates with a single, consistent validation methodology across all its facilities in India and the UK.
  • Increased Efficiency: Automation of workflows, document generation, and reporting has significantly reduced manual effort and accelerated validation cycle times.
  • Ensuring Data Integrity with ALCOA+ Principles: GoVal fundamentally strengthened Sai Life's compliance posture by embedding data integrity directly into their workflows. The platform enforces ALCOA+ principles through its core features, including comprehensive audit trails that capture every action, secure electronic records, and fully compliant e-signatures. This creates a single, un-editable source of truth, making the entire validation process secure, traceable, and perpetually audit-ready.
  • Complete Visibility: Centralized dashboards provide global leadership with unprecedented, real-time insight into validation performance and status across the entire organization.