Issue 6 2024

Issue 6 2024, Acquisition International | 17 Mastering Lean Validation Testing Through AI/ML rom “lean validation” through artificial intelligence and machine learning, OnShore Technology Group has pioneered IV&V innovation for life sciences companies. Empowered by its dynamic founder and an experienced professional team – each aligned with the goal of reinventing the ways in which the industry views and executes validation and verification processes – the company has long championed the art of reshaping IV&V to save its clients time and money without compromising compliance. OnShore has earned its place as an innovator and leader in the Digital IV&V Management market. For global life sciences companies, validation is a mandatory process. In today’s regulatory landscape, review of quality processes and systems provides checks and balances that protect patient safety. As today’s enterprise applications become more complex, the ability to quickly and accurately test them is a critical business imperative. OnShore’s flagship ValidationMaster™ Enterprise Digital IV&V platform was designed specifically to manage the enterprise validation lifecycle and the FIRST to adopt AI/ML to accelerate validation testing. Designed to manage ANY type of validation process, the system automates the full validation process, eliminating the burden of manual, paper-based processes and allowing life sciences companies to realize time and cost savings that literally compound over time. ValidationMaster™ delivers a reusable test script library among other features that help life sciences companies maintain the validated state of their systems and processes. Digital validation using AI/ML has revolutionized validation testing by allowing companies to fully automate testing and thus, rapidly adopt and manage advanced technologies over time while ensuring sustained compliance and quality. The ValidationMaster™ platform can be used to validate ANY type of validation and through automation, eliminates the need for human interpretation of outcomes, providing truly unbiased results on system or process operation and performance. In a fraction of the time with a fraction of the human resources required for manual validation, ValidationMaster™ automates test script execution, saving screenshots, keystrokes, and test outcomes as well as auto-generating issue and incident tickets for anomalous results within the platform, providing a single source of validation truth. Each requirement is tracked to one or more test scripts (and each test script to one or more requirements) to demonstrate full and unequivocal compliance. Machine Learning in ValidationMaster™ “learns” the application as it is used by end users. Coupled with AI, the system accelerates test execution and documentation, by creating “self-healing” test scripts designed to update themselves as applications change over time. The bottom line for global life sciences companies is clear: Less Time + Less Manpower = Lower Costs. The real value comes with ValidationMaster’s ability to significantly reduce the potential for human error. In addition to saving time and money associated with identifying and correcting those errors during testing, the system improve the management of the enterprise validation program integrity and accuracy. By automating the validation process, ValidationMaster™ delivers irrefutable evidence of compliance that stands up to both internal and regulatory audits. ValidationMaster is the future of enterprise digital validation and OnShore Technology Group is a company to watch. Recognized as the Best Digital IV&V Solutions Firm in 2024, OnShore continues its pursuit of innovation, quality and compliance for life sciences companies as they seek to deliver new products to market through quality and compliance that change the lives of us all. Contact: Valarie King-Bailey Company: OnShore Technology Group, Inc Web Address: https://onshoretech.com/ Global life sciences companies face constant challenges as they navigate complex regulatory landscapes intended to assure quality of the medications, vaccines, supplements, devices, and patient-care consumables produced. Artificial Intelligence and Machine Learning (AI/ML) is rapidly changing validation. OnShore delivers a comprehensive suite of products and services to streamline and optimize validation – the company has earned the coveted Acquisition International’s title of Best International IV&V Solutions Firm 2024. F

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