Global Pharma Leader Adopts ValGenesis iClean for Digital Cleaning Validation
ValGenesis, Inc., a global leader in digital validation lifecycle management solutions, has announced a significant milestone in its collaboration with a major pharmaceutical and biotechnology company. This industry giant has expanded its use of the ValGenesis digital validation platform by integrating iClean, an advanced risk-based cleaning validation solution designed to fully digitize the entire cleaning validation lifecycle.
A Commitment to Digital Transformation
The pharmaceutical company, with a presence in over 80 countries and a workforce exceeding 90,000 employees, is at the forefront of delivering innovative therapies and healthcare solutions. Its latest initiative aims to enhance operational efficiency, regulatory compliance, and process standardization across its vast manufacturing network.
Previously, the company had employed a fragmented approach to cleaning validation, managing Stage 2 (cleaning validation) within the ValGenesis platform while handling Stage 1 (cleaning process design) and Stage 3 (continuous monitoring) separately. This separation led to inefficiencies, data silos, and process disruptions, particularly during stage transitions, technology transfers, and the preparation of annual product quality reviews (APQR). Recognizing these challenges, the company has now consolidated all three stages into a single, unified system by deploying iClean.
Enhancing Compliance and Efficiency with iClean
With the implementation of iClean, the company has revolutionized its approach to cleaning validation, achieving:
- Seamless Digital Integration: By integrating all three cleaning validation stages, the company eliminates cross-system vulnerabilities, ensuring a streamlined and consistent process.
- Automated Risk-Based Assessments: iClean enables risk-based process development, automating worst-case assessments, maximum allowable carryover (MACO) calculations, residual limit determination, and protocol generation.
- Real-Time Monitoring & Data Accessibility: With continuous monitoring capabilities, the company gains real-time access to critical validation data, improving its ability to respond to regulatory audits and inspections.
- Reduction in Human Error: The platform’s automation minimizes manual interventions, reducing the likelihood of errors and enhancing overall compliance with current good manufacturing practices (cGMP).
Standardization Across Global Sites
The company has outlined plans to deploy iClean across all its global manufacturing sites. This strategic move ensures uniformity in cleaning validation practices, mitigating inconsistencies and compliance risks. A harmonized digital approach will also support faster decision-making, particularly when scaling operations or introducing new products into the market.
The impact of this digital transformation extends beyond operational efficiency. By leveraging iClean’s AI-driven analytics, the company can proactively identify potential risks, optimize cleaning cycles, and drive cost savings in cleaning validation processes. Furthermore, the real-time dashboards provide actionable insights, enabling teams to make data-driven decisions swiftly.
Industry Impact and Future Outlook
ValGenesis views this milestone as a transformative step for the pharmaceutical industry. Steve Reynolds, Chief Revenue Officer at ValGenesis, commented on the significance of this development: “It is remarkable to see this global pharma leader pioneering the digital transformation of its cleaning validation lifecycle with our digital validation platform. By eliminating data silos and unifying all three stages of cleaning validation into a single integrated system, it is setting a new standard for efficiency, compliance, and operational excellence.”
He further added, “This strategic move not only accelerates validation processes but also reinforces the company’s commitment to innovation and regulatory leadership. We look forward to witnessing the profound impact of this end-to-end digital transformation across its global operations.”
ValGenesis remains committed to driving innovation in life sciences with cutting-edge AI-driven solutions that enhance accuracy, regulatory confidence, and operational excellence. By setting new benchmarks for validation and compliance, the company continues to be a key enabler of digital transformation in the pharmaceutical sector.
