IT Intelligence Bulletin – Infosys has 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.
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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.”
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