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.
[ 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.
Frequently Asked Questions
Questions about harmonised multi-site validation with GoVal.
Yes. GoVal supports multiple regulatory frameworks within a single instance. You configure each site's workspace to reflect the applicable regulatory requirements — FDA 21 CFR Part 11 for US-facing operations, EU Annex 11 for UK and European sites, and CDSCO requirements for Indian manufacturing. Protocol templates, approval hierarchies, and reporting formats are configured per site, while corporate QA retains a unified view across all jurisdictions.
GoVal supports project-level data isolation with client-specific workspaces, role-based access controls, and configurable data visibility rules. A client's validation records are accessible only to users explicitly granted access to that client workspace. Your internal QA team can see across all client projects; individual client contacts see only their own data. This is audit-defensible and regularly reviewed by GoVal's security team.
Standardisation in GoVal is enforced at the template level, not the cultural level. Corporate QA publishes locked protocol templates that every site must use as their starting point. Deviations from the approved template require a documented justification and central QA approval before a modified protocol can be executed. Sites retain flexibility in execution scheduling and local resource allocation; they cannot deviate from quality standards unilaterally.
Sai Life Sciences achieved global harmonisation across 10+ sites in a single deployment cycle. The typical approach is a 4–6 week core configuration phase (template library, approval workflows, site workspaces), followed by a site-by-site onboarding wave — typically 2–3 sites per month — with GoVal's implementation team running each site kickoff. Full global deployment for an organisation of Sai Life's scale is typically complete within 6 months.
GoVal's change control module supports multi-site impact assessments. When a change is raised against a validated system, GoVal identifies every site where that system is deployed and automatically generates a parallel impact assessment for each. Site QAs review their own assessments; corporate QA approves the consolidated change package. No site can proceed with implementation until the full multi-site change control is closed.
GoVal's enterprise pricing is structured around the number of active validated systems and sites, with volume tiers that make multi-site deployment more cost-efficient than single-site scaling. There is no per-user charge. The minimum engagement is typically a 12-month subscription covering an agreed number of sites and validated systems, with expansion options built into the contract. Pilot engagements at one or two sites before full enterprise commitment are available for organisations that need board-level evidence before signing.