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Alembic's Digital Leap:

100% Paperless Validation Success with GoVal

With a legacy of over 100 years, Alembic Pharmaceuticals, a leader in therapeutic segments like cardiovascular and CNS, embarked on a digital transformation journey to modernize its validation processes and uphold its commitment to quality.

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Alembic Pharmaceuticals Paperless Validation Success

[ FROM MANUAL TO DIGITAL ]

The Challenge of Paper-Based Validation at Scale

Before partnering with GoVal, Alembic's manual validation processes were resource-intensive. In a single year, the company conducted 343 CSVs, a monumental effort that consumed 9,336.5 days and generated 380,000 pages of paper. With an average completion time of 25 days per CSV, the process was slow and susceptible to data integrity issues and GDP errors.

They needed a solution to:

  • Eliminate manual errors and resolve GDP/DI issues.
  • Drastically reduce validation timelines and operational costs.
  • Automate the creation of critical reports like the RTM and VSR.
  • Harmonize validation practices across all their locations.

[ RAPID TRANSFORMATION ]

GoVal's Accelerated Digital Validation Solution

GoVal provided a comprehensive Validation Lifecycle Management System (VLMS) that transformed Alembic's validation processes, delivering a 100% digital, paperless environment with remarkable speed and efficiency.

Zero Paper, Printing & Scanning

GoVal completely eliminated the need for physical documents, saving 3.8 lac pages annually and removing storage and retrieval costs.

Massive Time Savings

With an average saving of 5 days per CSV, Alembic reclaimed 1,955 validation days per year through automated workflows and faster test execution.

Instant Audit Readiness

A centralized digital repository and automated traceability matrix ensure all documents are audit-ready 24/7 across all geographical locations.

[ VALIDATION REIMAGINED ]

GoVal's Proven Business Advantages

  • Improved Compliance: ALCOA+ principles are maintained through automated workflows and an electronic review and approval process, eliminating GDP and DI issues.
  • Automated Workflows: Deliverables-based review and approval workflows with automatic alerts and notifications eliminate physical document movement.
  • Cost Savings: Reduced storage, retrieval, and archival costs, combined with resource and lifecycle optimization, delivered significant financial benefits.
  • Harmonized Practices: GoVal enabled consistent validation practices across all of Alembic's locations, with the ability to extend documents to other sites.
  • Automated Reporting: The Traceability Matrix (RTM) and Validation Summary Report (VSR) are automatically prepared, saving 3-4 days per CSV.
  • Real-Time Visibility: A real-time status dashboard provides complete visibility of progress, enhancing project management and continued compliance.