SANTA CLARA, Calif., April 4, 2023 /PRNewswire/ — ValGenesis, Inc., the market leader in enterprise Validation Lifecycle Management Systems (VLMS), and ProQuality Network, experts in quality assurance (QA) and compliance, have partnered to provide life sciences companies with professional advisory and implementation services to enhance quality and compliance in manufacturing.
ProQuality Network with Headquarters located in Puerto Rico comprises a team of experienced quality assurance experts from the biosciences/life sciences industry. They assist resource-constrained companies in addressing all their quality related manufacturing challenges.
ValGenesis is the market leader in enterprise Validation Lifecycle Management Systems (VLMS), helping the world’s leading life sciences companies enforce compliance and standardization with 100% digital, risk-based validation software.
ValGenesis and ProQuality Network are helping companies evaluate digital transformation solutions in line with Pharma 4.0 requirements with special focus on quality and compliance. The companies leverage their deep expertise to adapt next-generation digital validation tools and strategies across the manufacturing process, helping clients provide error-free, compliant, and timely product delivery.
“ValGenesis and ProQuality Network are collaborating to provide solutions that drive predictable and repeatable quality assurance results every time,” says Bo Olsen, ValGenesis’ SVP of Partners. “We provide clients with the best digital solutions that ensure operational transparency and efficiency, helping them adhere to the most stringent regulatory requirements while significantly cutting down on validation cycle time.”
“We are pleased to partner with ValGenesis, as we have finally identified a reliable platform for managing the lifecycle of the validation quality system. The platform offers features such as functional specifications, URS, TM, and protocol templates, as well as full integration with audit trails, electronic signatures, workflow approval charts, discrepancy documentation, metrics, and many other functionalities that support validation knowledge management and enable data integrity,” says Elizabeth Plaza, President of ProQuality Network.
“With the acquisition of iRisk, the platform now also provides robust risk management software, including risk assessment tools and features that support compliance with regulatory body requirements, such as the new Annex-1 GMP for Aseptic Products manufacturing published by the European Commission and which must be implemented by August 2024 by all companies that supply aseptic medications to the European market. This regulation requires risk management across all operations, quality systems, control strategies, and decision-making processes,” Elizabeth says.
ABOUT PROQUALITY NETWORK
ProQuality Network is comprised of highly experienced professionals from the quality operations of the biosciences/life sciences manufacturing industry. The company provides qualified consultants and advisors to support clients’ quality related challenges through quality systems, quality risk management, compliance proactive improvement, compliance remediation, project management, and management consulting services. As industry and regulatory compliance experts, ProQuality Network offers technical expertise and manpower services around the world to resource-constrained companies that prefer to focus on their core business priorities. For more information, visit https://www.proqualitynet.com/
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
SOURCE ValGenesis Inc.