SANTA CLARA, Calif.--(

加利福尼亚州圣克拉拉--(

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)--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..

)--企业验证生命周期管理系统（VLMS）的市场领导者ValGenesis Inc.今天宣布，巴西一家著名的政府实体（巴西卫生系统疫苗和生物技术药物生产的基石）已选择ValGenesis iRisk将其质量风险管理（QRM）流程数字化。。

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.

这家著名的机构将实施ValGenesis iRisk，以优化从研发到成品制造的整个运营过程中的风险管理实践。采用该方法将包括所有相关部门，包括监管事务部门，以确保遵守关键的监管准则，如ANVISA的计算机化系统验证指南（No。

33/2020), GAMP 5 Second Edition, and FDA 21 CFR Part 11..

33/2020），GAMP 5第二版和FDA 21 CFR第11部分。。

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.

通过简化关键领域的风险管理，如环境监测、清洁验证、数据完整性、过程验证、偏差分类、设备鉴定和供应商管理，ValGenesis-iRisk将提高产品质量和安全性，提高运营效率，并确保法规合规性。

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..

这种积极主动的风险识别和缓解方法将使该机构能够做出明智的决策，防止潜在问题升级，最终保护其业务。。

'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.

ValGenesis首席营收官史蒂夫·雷诺兹（SteveReynolds）说，随着巴西继续扩大疫苗生产能力，ValGenesis-iRisk提供了创新和合规所需的工具全球制药领导者依靠ValGenesis-iRisk优化其药物开发流程和QbD框架以实现更高的效率。

We're excited to support this customer in advancing its critical drug pipelines.'.

我们很高兴能够支持该客户推进其关键药物管道。”。

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..

ValGenesis iRisk作为下一代风险管理平台引领潮流，将所有与风险相关的需求统一到一个单一的综合生态系统中。它在生命科学领域迅速而广泛的采用证明了它的重要价值。组织将这一成功归功于其协作生态系统、遵守现代监管准则、与各种数据源的无缝集成以及直观的用户界面，该界面有助于跨所有生产领域进行数据驱动、以风险为中心的决策。。

ABOUT VALGENESIS

关于瓦尔金斯

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.

ValGenesis Inc.是一个创新软件平台的创建者，该平台是管理生命科学公司基于法规遵从性的验证活动的基础。ValGenesis Inc.是第一个管理公司验证生命周期过程的企业应用程序的提供商。。

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.

FDA 21 CFR第11部分和欧盟附件11要求。作为第一个用于验证执行和批准电子管理的完全无纸化解决方案，ValGenesis被行业同行评审委员会选中，于2005年获得肠胃外药物协会（PDA）新创新技术奖。

For more information, visit .

有关更多信息，请访问。

www.valgenesis.com

www.valgenesis.com