Santa Clara, April 25, 2023: ValGenesis, a leading provider of enterprise validation lifecycle management systems, is proud to announce the release of its latest software product Process Manager, the world's first solution that digitizes the end-to-end risk-based cleaning validation lifecycle. The newest addition to the company's ValGenesis platform for life sciences, Process Manager offers customers data-centric digital transformation that simplifies and streamlines the cleaning validation process.
Cleaning validation is one of the most frequently cited programs by regulatory agencies. These citations result from failure to validate the cleaning process of equipment and facilities, an inadequate sampling plan, inadequate acceptance criteria, lack of justification for worst-case assessment, and more. Regulatory agencies expect companies to have a robust cleaning validation program.
ValGenesis Process Manager is designed to eliminate these commonly cited observations by digitizing, automating, and controlling the end-to-end cleaning validation lifecycle, all aligned to the FDA's lifecycle approach for cleaning validation.
The next-generation application enables life sciences companies to holistically apply risk-based digital transformation to their cleaning validation program, replacing paper-centric processes and disconnected silos of information. Its unique features include dynamic impact assessment of any change to the approved cleaning validation program for product, process, and equipment; precise identification of sampling locations through 2D or 3D equipment images; and automatic assessment of worst-case product and worst-case equipment, following the defined assessment process using configurable business rules. Process Manager enables robust risk assessment at each contact part level to minimize cross-contamination and ensures product safety.
“Digitization of validation is a key enabler of Pharma 4.0. ValGenesis is at the cutting edge of digital validation technology and is trusted by over 30 of the top 50 global life sciences companies for our validation lifecycle management system. But simply digitizing cleaning validation deliverables is insufficient. Our purpose-built cleaning validation solution emphasizes critical thinking upfront, helping life sciences companies build a risk-based approach and culture of quality in line with the most stringent regulatory requirements. In fact, two of the top 10 global life sciences companies have started implementing our groundbreaking cleaning validation solution,” says Dr. Siva Samy, CEO at ValGenesis.
ValGenesis Process Manager significantly reduces the time, cost, and effort required to complete the validation process, including data collection, analysis, and reporting. Companies improve their data integrity and audit readiness by using version control, audit trails, and eliminating manual entry. And the system's scientific validation and documentation of the cleaning process ensures residues are removed below established acceptance criteria throughout the lifecycle, boosting product quality and patient safety.
“ValGenesis Process Manager is revolutionizing how the life sciences industry approaches cleaning validation. With its end-to-end digital system, companies can optimize and harmonize their programs globally while ensuring product safety and regulatory compliance. This is truly a game-changer for the industry,” says ValGenesis CTO, Mike Hicks.
ValGenesis, Inc. is the creator of an innovative software platform that serves as a foundation for managing compliance-based validation activities in life sciences companies. ValGenesis is the provider of the first enterprise application for the efficient management of corporate validation lifecycle processes. This solution is fully compliant with U.S. FDA 21 CFR Part 11 and 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.
Further information:
Althea D’Sylva, ValGenesis Communications, +1 510-445-0505 Ex. 1026, althea.dsylva@valgenesis.com