SANTA CLARA, Calif., Oct. 10, 2023 /PRNewswire/ -- ValGenesis, Inc., the market leader in enterprise validation lifecycle management systems (VLMS), and VALSPEC a global provider of system validation and lifecycle services, have partnered to extend a suite of sophisticated ValGenesis products for life sciences clients in the U.S.Valspec is the leading provider of computer system validation and system lifecycle (SLC) services including the testing, commissioning, and qualification of manufacturing automation and IT systems. Valspec is a member of the Proconex family of companies, with a proven history in plant automation and engineering excellence.ValGenesis' end-to-end digital validation platform, which includes its flagship VLMS offering, helps any life sciences company enable stronger compliance, enforce standardization, and advance digital transformation across manufacturing operations.As a premium validation, risk, and process insight expert, Valspec will be ValGenesis' service and implementation partner for a suite of ValGenesis products, including VLMS Express, iRisk, and Process Insight. Purpose-built for the life sciences industry, these cutting-edge, cloud-based digital solutions converge process and risk-related imperatives into a unified ecosystem in the spirit of Pharma 4.0."Our comprehensive array of solutions equips companies to dissect multifaceted process and risk variables to generate profound insights across intricate manufacturing landscapes," says Bo Olsen, ValGenesis' SVP of Partners. "Together with Valspec, we will deploy these solutions to help companies remain compliant at all times and accelerate growth.""This collaboration signifies a pivotal leap forward in Valspec's mission to enhance efficiency, compliance, and reliability in the critical role we play in life sciences manufacturing," says Russ Abraham, Valspec's Director of Client Solutions. "Together, we are set to transform validation practices and empower the future of manufacturing excellence in life sciences."ABOUT VALSPECValspec, a global provider of system validation and lifecycle services, provides commissioning and qualification of digital GxP systems for clients in the life sciences industry

Valspec, a global provider of system validation and lifecycle services, was named a key partner in Genentech's Clinical Supply Center (CSC) project, which was recently recognized with the Facility of the Year (FOYA) 2023 Pharma 4.0 Category Winner Award by ISPE.

PHILADELPHIA, June 14, 2023 /PRNewswire/ -- Valspec, a global provider of system validation and lifecycle services, was named a key partner in Genentech's Clinical Supply Center (CSC) project, which was recently recognized with the Facility of the Year (FOYA) 2023 Pharma 4.0™ Category Winner Award by ISPE®.The CSC is a proof-of-concept facility in South San Francisco that "uses advanced manufacturing technologies and employs an agile, modular design to enable on-demand delivery of Genentech's medicinal pipeline to clinical trials patients," according to Genentech. As a Supply Partner and Key Participant, Valspec owned the Commissioning and Qualification scope for the plant's computerized systems—a critical role that would allow the plant to be released for clinical-scale manufacturing.Valspec leadership and SMEs were involved early in the project lifecycle, starting with the Automation Quality Project Plan (aQPP). Valspec developed the testing matrix based on user requirements and collaborated with the System Owners, Automation, Equipment C&Q, and QA project teams to gain approval. This alignment served as the roadmap for the project as the teams progressed through Detailed Design, Design Review/Design Qualification, and C&Q Testing activities.This project set a precedent for Pharma 4.0™ with its innovative design and advanced integration of digitalization and automation. The plant's automation stack is fully integrated from the plant floor through enterprise-level systems and combined with single-use equipment to create an extremely flexible environment that allows for rapid tech transfer. Beyond its novel plant technologies, CSC was Genentech's first large capital project executed with a paperless validation platform.With end-to-end innovation planned for the facility, Genentech's leadership managed a strong team of supporting players under a one-team approach, challenged to push the boundaries of execution