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India Pharma's Digital Leap:

GoVal's Paperless Validation Success

The customer is one among the leading pharma companies India and ranked amongst the leaders in therapeutic segment of cardiovascular (CV), central systema nervosum (CNS), gastro-intestinal (GI) and women healthcare (WHC).

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India Pharma Paperless Validation Success

[ FROM MANUAL TO DIGITAL ]

Addressing Key Validation Challenges

Our client, a leading pharmaceutical company, faced significant challenges with their manual validation processes. They sought a robust software solution to drive a digital transformation, moving away from error-prone manual Computer System Validation (CSV) to a streamlined paperless validation approach. Specifically, they aimed to:

  • Eliminate manual errors during testing, ensuring data integrity and accuracy.
  • Streamline review and approval processes, reducing bottlenecks and accelerating validation timelines.
  • Reduce validation and approval process timelines, improving time-to-market.
  • Improve operational efficiency across their validation lifecycle.
  • Automate test protocol execution, deviation recording, traceability matrix generation and Validation Summary Report creation.

By implementing a comprehensive digital validation solution, they aimed to achieve enhanced GxP compliance and significantly improve their overall validation workflow.

[ RAPID TRANSFORMATION ]

GoVal's Accelerated Validation Solution

GoVal provides a comprehensive Validation Lifecycle Management System (VLMS) designed to transform your validation processes. Our solution empowers life science companies to move beyond traditional, paper-based workflows and embrace a fully digital approach.

Week 1-12

Configuration & Validation Sprint

GoVal's platform was rapidly configured and validated, laying the foundation for a seamless digital transition.

Month 1

Rapid Setup & UAT

We established CSV and Change Management processes on the platform and completed UAT, ensuring user readiness.

Month 3

Live Implementation & Impact

In just 3 months, the GoVal solution was fully operational, with complete training and all validation artifacts delivered.

[ VALIDATION REIMAGINED ]

GoVal's Proven Business Advantages

  • 100% Paperless Transformation: GoVal eliminated all paper records, ushering in a fully digital VLMS environment.
  • Enhanced Risk & Compliance: FMEA-based risk assessments, GxP assessments aligned with SOPs, GAMP categorization.
  • Deep Dive Test Analysis: In-depth analysis of test cases and results, with streamlined discrepancy management.
  • Accelerated Testing: Parallel execution of test scripts, screen recording, and easy upload of instrument results and screenshots.
  • Project & Task Mastery: Validation project plan generation, with integrated task allocation and follow-up.
  • Centralized Document Control: Secure DMS for storing all generated PDF validation documents.
  • Instant Team Synergy: Collaborate instantly. Multiple users work together in real time, streamlining validation and boosting team efficiency.
  • Automated Reporting & Review: Automated Validation Summary Reports (VSR), system release certificates, and enabled periodic review processes.
  • Real-Time Metrics: Improved metrics on all process aspects, including a real-time validation status dashboard.
  • Audit Readiness: Significantly improved audit preparedness.