OnShore Technology Group: ValidationMaster – Mastering Innovation and Regulatory Compliance

Valarie King Bailey, CEO
Achieving sustained compliance within life sciences is not optional in today’s competitive business environment. In a world in which technology and innovation moves at the speed of thought, it’s not enough to follow the basic rudiments of compliance – you need to go beyond compliance to achieve good governance, efficiency and mastery. OnShore Technology Group validation engineers are masters in Independent Software Validation and Verification (IV&V). Headquartered in Chicago and under the leadership of CEO Valarie King-Bailey, OnShore offers an innovative Enterprise Validation Management (EVM) system known as ValidationMaster as well as a comprehensive portfolio of IV&V professional services to help life-sciences organizations master regulatory compliance and achieve their validation objectives.

Life sciences companies traditionally have spent significant time, money and resources validating enterprise computer systems as per regulatory guidelines. For decades, computer systems validation has been addressed using the same manual processes that have resulted in a piecemeal approach with very little automation and variable quantifiable value to the organization. To reach higher levels of IV&V mastery and maturity, OnShore believes life sciences companies must have the ability to effectively manage requirements, automatically capture and execute validation test scripts, deliver accurate, on-demand validation reports, track and manage incidents, establish a sound validation change control processes, on-demand validation intelligence, validation project management and tracking, and integrated document management to effectively manage all of the documentation derived from validation processes.

ValidationMaster was developed from their extensive experience with life sciences companies across the globe. The system is offered hosted or on-premise and features a “Bring Your Own Devices” (BYOD) strategy that allows you to execute test scripts or view the status of your validation project from any Apple, Windows or Android mobile device or tablet.
The system is designed to support lean validation principles that help eliminate waste and drive IV&V project efficiencies. “ValidationMaster is designed to work the way validation engineers work”, says Valarie. “Necessity is the mother of invention and innovation. I have validated many systems over the past 30 years and looked long and hard for a system that was true to the validation principles of ISPE GAMP as well as one that made my job easier and more efficient. ValidationMaster is the culmination of our many years of experience and is the first “green validation” system of its kind”, she continued.


From beginning to end, ValidationMaster™ promotes a green (paperless) and lean validation process that automates the entire validation lifecycle process and eliminates waste and inefficiencies


OnShore sees a paradigm shift in the way life sciences companies are approaching IV&V. Many global companies are outsourcing their testing functions and rapidly adopting cloud-based enterprise technologies that must be validated. To address these market requirements, OnShore Technology Group has established an IV&V testing center to deliver the highest achievable levels of software quality and cost-effectiveness for mission critical cloud or onpremise enterprise software validation and regression testing. Valarie’s favorite hobby is drumming. As every drummer knows, it is important to keep the beat of the music. With ValidationMaster, she hasn’t skipped a beat.

Company
OnShore Technology Group

Headquarters
Chicago, Illinois

Management
Valarie King Bailey, CEO

Description
Develops and delivers ValidationMaster™ Enterprise Validation Management system and a comprehensive portfolio Independent verification and Validation (IV&V) professional services to help life-sciences companies master regulatory compliance and achieve their validation objectives.