Issue 4 2021

Issue 4 2021 61 Validation Visionaries Secure Success Founded in 2004, the team at OnShore Technology Group has spent years dedicated to the development and delivery of innovative IV&V products and professional services for life sciences, government, and other highly regulated industries. Their award-winning product, ValidationMaster™ speaks to their commitment and ingenuity in this field. ValidationMaster™ fills a significant void in the market, as companies seek comprehensive solutions that can automate the validation testing process. ValidationMaster™ is designed to provide a 360-degree solution that is capable of supporting the full lifecycle of validation processes. It is a key part of the company’s overall strategy and mission. To this end, OnShore has pursued a continuous innovation strategy, ensuring that clients are able to take advantage of greater automation and efficiency. A key step in their progress towards innovation and compliance is OnShore’s unique cybersecurity qualification (CyQ) that assesses the readiness to protect, detect, respond, defend and recover from cyber- attacks on validated systems. The team is currently exploring artificial intelligence strategies for enhanced software assurance. With regard to OnShore’s service offerings, the team is focused on developing and deploying their innovative lean validation strategies which provide a more agile approach for software assurance. Lean validation is one of the many things that the OnShore team has pioneered and is a key part of the ValidationMaster software assurance methodology. This strategic methodology sets the firm apart from the rest of the industry. OnShore offers the first and only Lean Validation Enterprise Validation Management and Quality System designed to automate the development, review and execution of the end-to-end validation and verification testing process. Lean Validation focuses on the elimination of wasteful, inefficient processes and promotes a more streamlined and optimized validation process saving both time and money. Validation processes varies from company to company. Thus, OnShore begins each engagement with a validation workshop. The aim of the workshop is to develop an understanding of client requirements and to establish unity and teamwork. Establishing a teamwork-oriented relationship is essential for mutual success. By working collaboratively with the client in the early stages ensures a successful engagement. Once the foundation is established, weekly team meetings are arranged to discuss progress and to resolve any potential issues. As a project develops, the challenge is to keep track of the various stages and to ensure that the team is in constant communication with regard to any changes from the original project plan. OnShore offers each client a Validation Project Portal as part of the service offering. In the age of COVID and remote consulting, the Portal provides all document deliverables, status reports, issues list and other project deliverables to help each team harmonize their activities. This transparency ensures that the team remains on time, and on budget. OnShore seeks to deliver greater value to its clients as the premier IV&V solutions provider. Technologies such as artificial intelligence (AI), When implementing and deploying new technologies within life sciences, independent validation and verification (IV&V) is a vital step forward. The automation of this process could save the industry a great deal of money, while ensuring efficiency and sustaining compliance. When OnShore Technology Group, Inc. developed ValidationMaster™, it was to fill the gap in the market. For their efforts, they became Recognized Leaders in Enterprise Validation Lifecycle Management 2020 in the Small Business Awards. We dug a little deeper to find out more. Robotics Process Automation (RPA) and others offer significant promise to the life sciences community by automating routine processes that were previously manually driven. The need for greater software quality and sustained compliance will continue to inspire the OnShore team to further develop ValidationMaster™ into a global leader for IV&V and quality teams. The future seems bright for OnShore, and for their impressive flagship product ValidationMaster™. The work they do is not only dynamic, but forward thinking in every respect. They have not just filled a market gap, but sealed their position as a formidable global competitive force. Company: OnShore Technology Group, Inc. Name: Valarie King-Bailey Web Address: Email: [email protected] Oct20610