Technology Innovator Awards 2017

36 Corporate Vision / Technology Innovator Awards 2017 , OnShore Technology Group is dedicated to providing validation solutions and services to the life sciences industry. CEOValarie King-Bailey tells us more about the firmand how the solutions it offers meet the varied needs of its clients. Best IV&V Automation Solutions Provider 2017 & Software Validation Testing Experts of the Year 2017 Originally founded in 2004 as an Independent Validation and Verification (IV&V) company OnShore Technology Group has since flourished, and remains dedicated to providing products and services that support its “Lean” validation methodologies which are designed to eliminate waste throughout the validation lifecycle and optimize processes while improving efficiency and lowering costs. Valarie discusses the firm’s service offering in more detail. “As a pioneer in the validation services industry, at OnShore Technology Group we have developed and delivered the first Enterprise Validation Management and Quality (EVMQ) system marketed as ValidationMaster™. This innovative EVMQ application is designed to fully automate the validation process and includes key features such as requirements management, incident management, automated validation testing, flexible reporting, real-time dashboard reporting, integrated SharePoint- based ValidationMaster portal, 21 CFR Part 11 electronic records/signatures capabilities and the first validation Kanban board to support Agile validation processes. “Specifically with regards to our validation services, we offer a comprehensive portfolio of services designed to provide expert guidance and compliance for our clients. Our two core service offerings include ValidationCoach and ValidationPro. ValidationCoach is validation coaching and staff augmentation service designed to deliver experienced validation professionals on demand. Through our ValidationCoach service offering, we work with our clients’ internal validation personnel to assist them as needed with the development of validation document deliverables and testing in accordance with global regulatory guidelines and ISPE GAMP 5® methodologies. Through our flexible ValidationCoach service, each client sets their project priorities, goals, and budget for the level of validation coaching they require. “Our most popular service is ValidationPro, which is a full-service, turnkey validation service that delivers a ready-to- work validation team for each engagement. Our ValidationPro team consists of a ready-to-work Validation Project Manager, Senior Validation Engineer, and Senior Validation Technical Engineer. Our team has deep technical and compliance domain experience across multiple life sciences industry sectors as well as practical working knowledge of the latest enterprise technologies. We bring the latest best practices and validation principles to each project saving client both time and money. We also offer “Validation Accelerators” for the leading ERP technologies including Microsoft Dynamics 365®, Microsoft NAV®, Microsoft GP®, Oracle e-Business®, SAP®, Epicor®, and many others. Our Validation Accelerators are coupled with ValidationMaster™ to jumpstart any validation project saving up to 60% of the effort required for typical validation project.” What truly sets the firm apart, according to Valarie, is its innovative approach, which is unlike anything offered by its competitors. “Our uniqueness lies in the creative ways in which we leverage advanced technology in the development and delivery of validation products and services. An example of this is our pioneering “Lean” validation methodology. We are the only lean IV&V company in the market. Our methodology is based on the principles of lean manufacturing designed to eliminate waste and non- value added work throughout the manufacturing process. We took lean manufacturing principles and applied them to manual, paper-based validation processes where there is much waste. “The cornerstone of our strategy is automation. We leverage advanced technologies such as mobility and the cloud to automate manual paper- based validation processes to more automated paperless validation processes that are designed with compliance objectives built in. Our clients choose us because we practice 21st-century validation using automated paperless validation processes. We get the job done faster and better than any of our competitors.” In order to remain ahead of its competitors and ensure that clients continue to receive the very highest quality service and solutions on the market, OnShore Technology Group works hard to stay at the forefront of emerging market developments, as Valarie is eager to emphasize.