The Silicon Review
The current competitive business environment has led to an embrace of ever-complex technologies requiring greater security, quality and compliance. Global regulatory mandates coupled with time and budget constraints, companies are looking to ensure sustained quality and compliance as they embrace enterprise cloud and mobile technologies to drive business. This is where OnShore Technology Group comes in to ensure software quality and compliance while reducing cost and without compromising the quality of the deliverables.
OnShore Technology Group was established in 2004 due to offshore outsourcing trends to become a leading global Independent Validation and Verification (IV&V) firm. Back then, IV&V was conducted using laborious, manual and mostly inefficient processes. Although software innovation was accelerating at a rapid pace, testing tools compliant with current regulatory requirements that could be leveraged for cloud or on-premise systems were not available. OnShore having years of experience in conducting IV&V projects for global life sciences companies recognized this drawback. There were no dominant industry players in the IV&V market sector, and OnShore was the first company to deliver the first FDA Validation Toolkit for Microsoft Dynamics AX and Microsoft NAV, Microsoft GP and BatchMaster Enterprise Batch Records Management software.
Managing validation efforts and ensuring compliance
The first product that OnShore launched was the ValidationMaster™ enterprise validation management system. It is designed to manage the full lifecycle of validation projects including computer systems validation, process validation, equipment validation, facility validation, etc. The system leverages the Microsoft solution stack and includes a fully integrated quality management portal based on Microsoft SharePoint portal. The system includes features for requirements management, validation test script management, release management, automated validation test execution, validation reporting, validation incident management, quality management, risk management, training, and even a validation dashboard that provides real-time status of any validation project. The system also includes the first validation Kanban board to support lean validation efforts. The product is delivered either on premise or hosted via annual subscription.
For their first project, OnShore validated a system for a global nutraceutical company. As it was their first project, they developed the documentation for the validation toolkit throughout the implementation. With over 25 years of validation experience they were able to hit the ground running on their first project. “We have adopted what we call a lean validation strategy which is designed to minimize waste and optimize the validation process through the use of automated tools such as ValidationMaster which are designed to save our clients both time and money.”
Developing validation strategies with ValidationPro and ValidationCoach
In 2008, during the economic crisis, the company reviewed its service offerings to determine which services were most beneficial to its clients and provided the greatest value. It branded its product services and focused on the top two services that its clients indicated were most valuable, ValidationPro and ValidationCoach. The ValidationPro helps in managing the full lifecycle of the validation project and prepares all validation document deliverables for the customer. Through its ValidationCoach service offering, it coaches existing validation project engineers who may require assistance in validating complex enterprise software applications that they may not be familiar with. The customer is allowed to define the boundaries of the service engagement as well as the service level. Thus, the customers can budget according to their unique requirements. “Whether full-service or coaching is required, we offer a flexible path to help you achieve your goals.”
Optimized project management in budget and on time
OnShore consultants have deep regulatory, enterprise technology, and life sciences domain experience. Its Validation Specialists have a minimum of ten years experience in the validation of large enterprise technologies such as Enterprise Resource Planning (ERP), Enterprise Quality Management, Enterprise Document/Content Management systems as well as others. Across the globe, life sciences companies rely on OnShore Technology Group to help deliver validated systems on time and within budget.
OnShore is constantly seeking new innovative ways to validate systems in the most cost-effective manner. Its innovative solution, ValidationMaster, is an example of that. Through ValidationMaster, clients are able to streamline the validation process but more importantly, they are effectively managing their validation projects saving time and money. ValidationMaster can also be leveraged to track the activities and costs across multiple validation projects to help ensure visibility to all the validation projects in an easy to use system. “ValidationMaster is a game-changer and is changing the way validation is done in the 21st century.”
Let’s meet the leader behind OnShore Technology Group, CEO Valarie King-Bailey:
Valarie King-Bailey is the CEO of OnShore Technology Group, an independent Chicago-based consultancy specializing in Independent Validation and Verification (IV&V) services and solutions. She has worked for leading global companies such as QUMAS Limited, EMC/Documentum, Abbott Laboratories, and U.S. Steel – South Works. Valarie is a seasoned executive and a noted compliance expert. She has received numerous honors including IVT speaker of the year for 2015, E&Y Entrepreneur of the Year nominee and others.
Ms. Valarie holds an M.B.A. in Information Systems from Keller Graduate School of Management and a B.S. in Civil and Environmental Engineering from the University of Wisconsin. She is a member of the American Society of Civil Engineers, Society of Women Engineers, and National Girls Collaborative Project for STEM education, Regulatory Affairs Professional Society, and a U.W. College of Civil Engineering Advisory Board Member.
“As a technology company we live and die based on our ability to develop innovative solutions to today’s market challenges. We are constantly thinking of better ways to assist our clients and help them to optimize business processes saving them time and money.”