ValGenesis iRisk Selected to Support Safer, Compliant Vaccine Production and Distribution in Brazil
Althea D'Sylva, ValGenesis Communications, +1 510-445-0505 Ex.1026 althea.dsylva@valgenesis.com
ValGenesis Inc., the market leader in enterprise validation lifecycle management systems (VLMS), announced today that a prominent Brazilian government entity, a cornerstone of vaccine and biotechnological medicine production for the Brazilian Health System, has chosen ValGenesis iRisk to digitize its quality risk management (QRM) processes.
The renowned institution will implement ValGenesis iRisk to optimize risk management practices across its operations— from research and development to finished product manufacturing. The adoption will include all relevant departments, including Regulatory Affairs, ensuring compliance with key regulatory guidelines such as ANVISA's Computerized Systems Validation Guide (No. 33/2020), GAMP 5 Second Edition, and FDA 21 CFR Part 11.
By streamlining risk management across critical domains such as environmental monitoring, cleaning validation, data integrity, process validation, deviation categorization, equipment qualification, and supplier management, ValGenesis iRisk will enhance product quality and safety, improve operational efficiency, and ensure regulatory compliance. This proactive approach to risk identification and mitigation will empower the institution to make informed decisions and prevent potential issues from escalating, ultimately safeguarding their business.
"As Brazil continues to expand its vaccine production capabilities, ValGenesis iRisk offers the tools necessary for innovation and compliance," says Steve Reynolds, ValGenesis chief revenue officer. "Global pharmaceutical leaders rely on ValGenesis iRisk to optimize their drug development processes and QbD frameworks to achieve greater efficiency. We're excited to support this customer in advancing its critical drug pipelines."
ValGenesis iRisk leads the way as a next-generation risk management platform, unifying all risk-related imperatives into a single, integrated ecosystem. Its rapid and widespread adoption within the life sciences sector demonstrates its significant value. Organizations credit this success to its collaborative ecosystem, adherence to modern regulatory guidelines, seamless integration with diverse data sources, and an intuitive user interface that facilitates data-driven, risk-centric decision-making across all production domains.
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
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