Global Pharma Leader Digitizes Entire Cleaning Validation Lifecycle with ValGenesis iClean

SANTA CLARA, Calif.--(BUSINESS WIRE)--ValGenesis, Inc., the market leader in digital validation lifecycle management solutions, announced that a global pharmaceutical and biotechnology leader has successfully expanded its use of the ValGenesis digital validation platform by deploying iClean, a risk-based cleaning validation solution that digitizes the entire cleaning validation lifecycle.

With a global footprint spanning over 80 countries and a workforce of more than 90,000, this company provides innovative therapies and health solutions across pharmaceuticals, consumer healthcare, and biotechnology.

Already leveraging the ValGenesis platform for Stage 2 cleaning validation, the company has now unified all three stages of design, qualification, and continued process verification within a single integrated system. This strategic move enhances operational efficiency, eliminates cross-system vulnerabilities, and strengthens compliance with current good manufacturing practices (cGMP).

Previously, the company relied on a mix of digital systems. Stage 2 was managed within the ValGenesis platform, while Stages 1 (cleaning process design) and 3 (continuous monitoring) were handled separately, resulting in data silos and process inefficiencies, particularly during stage transitions, technology transfers, and the preparation of annual product quality reviews (APQR). By transitioning the entire cleaning validation program into iClean, the company has eliminated these gaps, establishing a digital, end-to-end solution. It plans to deploy iClean at all global manufacturing sites to streamline and standardize the cleaning validation process.

The integrated system now automates the entire cleaning validation lifecycle, from risk-based process development to automated worst-case assessments, MACO calculations, residual limit determination, and protocol generation. It enables digital execution of cleaning validation protocols, and dynamic impact assessments, along with real-time and continuous monitoring across all stages. This unified digital approach provides instant access to data for audits and inspections, significantly reduces the risk of human error, and ensures consistent compliance with internal policies and global regulatory standards.

“It is remarkable to see this global pharma leader pioneering the digital transformation of its cleaning validation lifecycle with our digital validation platform,” said Steve Reynolds, chief revenue officer at ValGenesis. “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.

“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.

“This milestone underscores ValGenesis’ unwavering commitment to transforming validation in life sciences through cutting-edge, AI-driven digital solutions that drive efficiency, enhance accuracy, and strengthen regulatory confidence, setting a new benchmark for innovation and compliance.”

ABOUT VALGENESIS

ValGenesis, Inc. is the creator of an innovative software platform that is a foundation for managing compliance-based validation activities in life sciences companies. ValGenesis, Inc. is the provider of the first enterprise application that manages the corporate validation lifecycle process. This solution is fully compliant with U.S. FDA 21 CFR Part 11 and EU Annex 11 requirements. As the first fully paperless solution for electronic management of validation execution and approval, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association (PDA) New Innovative Technology Award in 2005. For more information, visit www.valgenesis.com