ValGenesis Revolutionizes Risk Management with New iRisk Tool Sets

Santa Clara, September 12, 2023: ValGenesis, Inc., the market leader in enterprise validation lifecycle management systems (VLMS), proudly unveils the much-anticipated ValGenesis iRisk 3.8. This cutting-edge release marks a pivotal moment in risk management, introducing an industry-defining solution for digitizing and elevating risk management strategies.

ValGenesis iRisk emerges as the vanguard of next-generation risk management platforms, converging all risk-related imperatives into a unified ecosystem. This revolutionary creation empowers life sciences enterprises to detect and evaluate risks and meticulously categorize, prioritize, and deploy mitigation strategies with precision, all within a dynamic and singular platform. A significant number of pharmaceutical giants have entrusted iRisk to catalyze their risk management efforts, spanning diverse arenas such as process risk management for QbD, clinical trial risk management, vendor risk management, and quality risk management requirements.

ValGenesis introduces transformative features within iRisk 3.8 by bolstering the suite through immersive customer collaboration. The addition of gap assessment and critical entity assessment tools amplifies operational agility, empowering users to manage process variables and material characteristics fluidly. This advancement promises a seamless data orchestration and reporting framework, poised to redefine the contours of risk management practices.

Noteworthy features within iRisk 3.8 include:

  • Effortless replication of existing ranking and workflow templates
  • Dynamic data sorting, filtering, and validation capabilities
  • Enriched reporting prowess with integrated text and image attachments
  • Elevated ranking mechanisms, now endowed with customizable input options spanning criticality, analysis, impact versus uncertainty, and intricate cause-and-effect dynamics.

This comprehensive array of assessment tools equips enterprises to dissect multifaceted risk variables, allocate responsibilities, and establish quantifiable benchmarks, generating profound insights across intricate manufacturing landscapes. ValGenesis iRisk seamlessly spans all GxP stages, cementing its status as an indispensable asset.

The exponential surge in ValGenesis iRisk adoption underscores its inherent value to the life sciences sector. Boasting a collaborative ecosystem, adherence to modern guidelines, interoperability with disparate data sources, and an intuitive user interface driving risk-centric decisions, iRisk's triumph resonates loudly across production domains.

Dr. Siva Samy, CEO at ValGenesis, said, "Amidst an ever-evolving business paradigm, the need for operational efficiency and agile risk management within drug development has never been more pressing. iRisk is the quintessential solution, mitigating risks effectively, amplifying decision-making precision, and securing operational continuity even during disruption. It's the very embodiment of operational transparency."

Kevin Shaw, Vice President of Product Management at ValGenesis, emphasizes, "ValGenesis iRisk is meticulously designed to seamlessly integrate risk management while fostering comprehensive user collaboration, transcending geographical barriers. Our solution not only meets but exceeds the rigorous standards outlined by FDA, EU GMP Annex 15, EMA, and ICH regulations, a testament to our unwavering commitment to effective risk governance."

ValGenesis continues redefining risk management benchmarks, empowering life sciences entities to flourish amidst challenges and uncertainties through unparalleled innovation and precision.

About ValGenesis

ValGenesis, Inc. is the creator of an innovative software platform that is a foundation for managing compliance-based validation activities in life science 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 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

Further information

Althea D'Sylva, ValGenesis Communications, +1 510-445-0505 Ex.1026