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Infosys, a global leader in consulting, technology and next-generation services, today announced a new partnership with paperless validation company ValGenesis, that will bring even stronger compliance and quality management for its customers in the healthcare and life sciences sectors. Under the partnership, Infosys will integrate ValGenesis’ Validation Lifecycle Management System (VLMS) within its suite of services for the pharmaceutical and biotech industry, which will be delivered in a rapidly deployable, highly secure cloud environment.
ValGenesis is a leading paperless validation lifecycle management solution in the life sciences industry that allows customers to automate the validation process fully, eliminate inefficiencies found in paper-based manual processes, while also reducing costs and validation cycle times. The ValGenesis Validation Lifecycle Management System (VLMS) efficiently manages all types of validation activities such as equipment, computer systems, cleaning, analytical methods, and process validation. The system delivers technology solutions that are fully configurable and rapidly deployable onsite or by way of a secured cloud environment.
Validation systems are still almost entirely manual, paper-based process, resulting in significant inefficiencies, higher costs and more significant opportunity for errors to creep in. They can also result in delays to life-saving medicines and procedures to patients. ValGenesis’ VLMS includes a regulatory framework allowing validation requirements to be specified in advance. Risk Management, a key component of VLMS, is integrated and flexible, giving companies the ability to leverage standard risk tools to best suit their needs. Reusability is inherent and available at test and requirement levels, significantly improving efficiency via pre-approvals. Consistency is also driven by standardization which improves a company’s compliance posture.
Infosys’ Life Sciences Practice works with 50+ leading pharmaceutical and medical devices companies, providing premium regulatory, quality and compliance services. Leveraging its extensive capabilities and experience in the life sciences space, Infosys will deploy the ValGenesis Validation Lifecycle Management System (VLMS) to its customers as a single “paperless” system that manages every activity in the entire validation lifecycle. Through this partnership, Infosys will help biopharma and medical devices customers transform to next generation of automation driven quality and compliance services which will help organizations generate significant efficiencies and allow them to focus on their core business.
Sangita Singh, Executive Vice President and Head, Healthcare & Lifesciences, Infosys, said,“Healthcare is potentially the world’s most stringently-regulated industry. The huge volumes of highly-sensitive information that biotech and life sciences firms generate is subject to incredibly strict standards for example, recording the outcomes from clinical trials. The digitization of the industry to ensure better data and document accuracy is incredibly important for many ethical, legal and business reasons, with auditors and regulators demanding that data regarding equipment, computer systems, processes, and outcomes be properly recorded and validated. ValGenesis is pioneering paperless validation, and our new partnership will bring significant savings and much better compliance to our customers.”
Narayan Raj, VP Sales at ValGenesis, said,“Infosys’ long pedigree in life sciences makes them the perfect partner for ValGenesis as we seek to transform validation for the life sciences and biomedical sectors. Infosys has a comprehensive understanding of the pressures faced by these firms, such as the demand for reducing costs, optimising efficiency, and ensuring that they meet the most stringent regulatory requirements. We look forward to a long and fruitful partnership, with ValGenesis’ technology complementing Infosys’ product set to redefine the way that biopharma firms conduct their business, optimising patient safety, and helping to bring new treatments to the public as quickly and safely as possible.”
About ValGenesis
ValGenesis, Inc. (valgenesis.com) is the creator of an innovative software platform serving as the foundation for managing compliance-based validation activities in Life Sciences companies. ValGenesis, Inc. provides the first enterprise application to manage the corporate validation lifecycle process. As the only system for managing validation execution and approval 100% electronically, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association (PDA) New Innovative Technology Award. The solution is fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements.
About Infosys
Infosys (infosys.com) is a global leader in technology services and consulting. We enable clients in 45 countries to create and execute strategies for their digital transformation. From engineering to application development, knowledge management and business process management, we help our clients find the right problems to solve, and to solve these effectively. Our team of 198,000+ innovators, across the globe, is differentiated by the imagination, knowledge and experience, across industries and technologies that we bring to every project we undertake.
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