Santa Clara, June 26, 2024, ValGenesis Inc.
ValGenesis successfully concluded ValConnect, its annual customer and partner conference, in Lisbon on Wednesday, June 19th, after hosting an impressive series of product announcements and customer success stories to customers, partners, and industry experts.
Influential leaders from across life sciences presented at ValConnect 2024, leading the audience in an inspiring and immersive experience. This included FDA’s Policy Analyst of Compliance and Quality Staff, Daniel Walter; plus Dr. Imtiaz H. Mohiuddin, Senior Director, Global Quality Solutions (GQS) from Otsuka; Dr. Iris Ziegler, Director QbD & Pharmaceutical Sciences from Corden Pharma; Sigrun Seeger, Global Process Manager ValGenesis, GPO GxP Computerized System Life Cycle, and Verena Buhl, GPO Validation and Qualification, GPO ValGenesis, from Bayer; Bianca Valentim, Global Product Process Lifecycle Validation Senior Specialist from GSK; Susanne Weiler, Senior Risk Manager, Pharmaceutical Development Biologicals from Boehringer Ingelheim; Alexandre Zegels, Team Manager & Senior Consultant, and William Astier, Digital Transformation Consultant, CMC Science, from CSL Behring; Mani Palaniappan, MSAT Validation Expert from Roche, Singapore, and other distinguished speakers.
FDA’s Daniel Walter presented two Case for Quality projects – Make CAPA Cool and Computer Software Assurance – as examples of focusing on risk-based business practices. Walter said, “The key point in both projects is the growing focus on risk, which is a pivotal component in decision making for all parties in life sciences product manufacturing.”
Dr. Mohiuddin presented Otsuka's CSA digital transformation journey with ValGenesis. “We took a proactive approach to embracing change through active engagement and promotion of the new CSA paradigm. Adopting critical thinking through CSA helped us reduce the number of steps by 40% in the current CSV process,” he says. Otsuka also experienced a 25% reduction in validation cycle time through integrated processes after unifying their processes within ValGenesis VLMS.
Mani Palaniappan also led the audience through Roche's digital transformation journey with ValGenesis VLMS driving their global paperless validation and qualification system. “ValGenesis VLMS is helping us create a robust foundation for efficient, compliant, and globally interconnected validation and qualification systems. An added benefit is an estimated 50% reduction in cycle time, which is very significant in terms of a qualification program,” he presented.
Seeger and Buhl unpacked Bayer’s 15-year journey with ValGenesis, moving from paper-based validation and qualification to a fully digital enterprise today.
“Bayer commenced with ValGenesis as a local system and turned it into a global system,” said Seeger. “With more than 26 sites all over the globe, standardization takes on a whole new meaning,” she says. Buhl provided additional data to illustrate their scale of VLMS deployment: 3,500 global system change requests, 22,000 maintained entities, 42,000 executed test cases, and 4,000 users.
In addition, four companies spoke about their experience with iRisk.
Zegels and Astier explored iRisk as an eQbD knowledge management system at CSL Behring that helped them digitalize, centralize, and automate their QbD documentation suite in plasma product development CMC at CSL.
Weiler discussed the implementation of iRisk for effective knowledge and risk management at Boehringer Ingelheim (BI). iRisk was implemented in Development Biologicals for the end-to-end process, from CQA assessment over different types of risk assessments to control strategy summary. “iRisk provides a structured approach for knowledge management through easy access and links to all relevant process and product data,” she demonstrated.
Valentim took the audience through a timeline of GSK Vaccines' journey with iRisk, the milestones along the way, benefits achieved, and the next steps. “iRisk as a QbD platform for knowledge management is helping us connect product understanding, process understanding, and analytical strategy to build our product control strategy,” she says.
Finally, Dr. Ziegler shared insight on Corden Pharma’s journey of deploying ValGenesis iRisk as a centralized QRM application, and the benefits for the development and lifecycle management of Corden Pharma's products. “iRisk is everything we hoped a QRM software application would be. Quality risk management is not just about risk assessment but about systematic quality risk management throughout lifecycle management, and iRisk makes this possible,” she said.
ValGenesis’ Vice President of Product Management, Kevin Shaw, kicked off this year’s conference lifting the curtain on VLMS 5.0. Shaw discussed the new capabilities and future of VLMS, iRisk, Process Manager, Process Insight, e-Logbook, plus key advancements to help customers cross the Validation 4.0 chasm. “We are closer to converging our products on a single, ‘Smart Validation’ platform for manufacturing intelligence,” Shaw says.
ValGenesis is a pioneer in the development of automated validation software solutions and leads the way with a unique paperless validation process that tracks the validation status of GxP systems corporate-wide, in real time. ValGenesis currently supports well over 100,000 GMP systems around the world and a majority of the world’s top 50 life sciences companies are ValGenesis customers.
About ValGenesis
ValGenesis, Inc. is the creator of an innovative software platform that serves as 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 www.valgenesis.com
Further information:
Althea D’Sylva, ValGenesis Communications, +1 510-445-0505 Ex. 1026, althea.dsylva@valgenesis.com