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.
[ 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.
Frequently Asked Questions
Questions about Alembic Pharma's paperless validation journey with GoVal.
GoVal was purpose-built for high-volume validation environments. Parallel project execution means multiple CSV projects run simultaneously without contention. Centralised template libraries ensure every project starts from a pre-approved baseline rather than from scratch. At Alembic's scale, the cumulative time saving of 5 days per CSV across 343 projects translated to 1,955 validation days recovered per year — a material operational gain, not a marginal one.
You do not migrate it — you archive it. Legacy paper records remain as your compliance evidence for already-validated systems. GoVal is introduced as a new validated system under your existing change control framework, and all new validation activity runs digitally from that point forward. There is no requirement to digitise historical binders to achieve 100% paperless status for new projects. Alembic's transition followed exactly this approach.
GoVal enforces consistency through a centralised protocol library. Corporate QA publishes approved template versions that all sites draw from — no site can execute a protocol that has not passed central approval. When a template is updated, all active sites are notified and must acknowledge the change before executing new projects. This eliminates the version drift that causes inconsistencies in multi-site paper-based operations.
At a conservative all-in cost of £500–£1,000 per validation day (staff, review, printing, storage, and approval overhead), a 25-day CSV costs £12,500–£25,000. GoVal reduced Alembic's average per-CSV timeline by 5 days, saving approximately £2,500–£5,000 per project. Across 343 annual projects, that represents £860,000–£1.7M in annual operational savings — before accounting for reduced audit preparation costs and storage elimination.
If your inspection is more than 6 weeks away, GoVal can be deployed and running live validation projects before the inspection date. The more immediate value is that GoVal can be used to organise and cross-reference your existing paper records digitally, making retrieval dramatically faster during inspection even before full paperless transition is complete. GoVal's team has supported customers through time-pressured deployments ahead of announced regulatory visits.
Yes. GoVal supports phased deployments. The standard path is a single-site pilot — typically 90 days — that gives your QA leadership direct evidence of time savings and compliance quality before committing to a multi-site rollout. Expansion to additional sites is contractually straightforward, with no renegotiation of core terms. Customers who pilot at one site consistently expand within 12 months.