OnShore Technology Group (OnShore) is an independent validation and verification firm (IV&V) on a mission to become a leader in the global life sciences industry. As an IV&V, the firm helps companies validate or test computer systems, equipment, laboratories, processes, and many other projects. With its digital validation solutions and professional services, OnShore Technology Group aims to be the premier enterprise digital validation management and quality system. For its pioneering lean validation methodology, OnShore Technology Group has received a Global Excellence Award for this year’s Leading Innovators in Life Sciences IV&V Software.
Established in 2004, OnShore Technology Group is a Chicago-based consultancy founded by CEO Valarie King-Bailey. OnShore’s offerings are designed to streamline companies’ validation processes and help clients transition from paper-based processes to automated lean validation processes. The company has pioneered the concept, principles, and best practices of lean validation. Its lean methodologies are powered by ValidationMaster, the first lean enterprise validation management and quality system designed to automate IV&V processes and facilitate the lifecycle of all types of validation projects. The system increases the efficiency of validation processes and project delivery while saving clients time and money.
ValidationMaster provides clients with project and personal IV&V dashboards that offer real-time actionable intelligence and status updates on project metrics and activities. With comprehensive test script management, clients can automate the creation of test scripts to verify system changes, software quality, and visualise risk. Report automation allows clients to easily customise, share, and export their validation reports in a format of their choice. ValidationMaster is the most comprehensive digital validation accelerator used by life sciences companies across the world. The software application has been recognised by CIO Review Magazine as one of the top 20 most promising technologies for life sciences in 2018.
OnShore serves clients within the pharmaceutical, medical device, biotechnology, vaccine, nutraceutical, and other life sciences market sectors that deliver lifesaving therapies to patients. Its core values are customer service excellence, innovation, respect, and teamwork. At OnShore Technology Group, customers are at the heart of its operations. The firm is driven by its pursuit of excellence and aims to deliver quality products and services that exceed clients’ expectations. OnShore has achieved success through its ongoing commitment to customer satisfaction and employee wellbeing.
Staff at OnShore are the firm’s most important asset and their valuable contributions have shaped the future of the company. When recruiting for new validation engineers and staff positions, OnShore seeks individuals who possess creativity and think outside the box. New recruits must be curious, flexible, and able to work productively with clients. The company’s internal culture is friendly and open, but also one of compliance and strict about how they manage customer information. With the help of its superb team, OnShore delivers superior products and services that help boost clients’ bottom line while saving them time and money.
The company differentiates itself from competitors through continuous innovation and its drive for excellence. OnShore was the first company to integrate artificial intelligence and machine learning into its validation testing. This pioneering work has produced the first mobile application designed to automate process and equipment validation processes. It is OnShore’s mission to help clients master quality and regulatory compliance when delivering their validation projects. ValidationMaster enables companies to ensure sustained compliance through automation.
As an innovative technology company, OnShore aims to become a market leader within its industry through continuous development. One specific challenge facing customers is changing regulations by the FDA and other global regulatory bodies. OnShore periodically updates its software and services to meet the current industry demands. The team also utilises industry feedback and listens to customers’ opinions to stay updated on market conditions. The firm participates in industry events which deliver current thought leadership and ideas that can enhance its products and services. OnShore is driven by its pursuit of excellence and innovation which ensures that clients receive the highest quality of offerings.
Prior to the pandemic, many clients viewed the automation of the validation process as a luxury rather than a necessity. CEO Valarie King-Bailey says, “During the pandemic, I started to receive many calls from prospects who recalled seeing a demo of ValidationMaster and its automation features and wanted to revisit the automation process again. This was an unexpected henomenon that led to our listing as one of the INC 5000 fastest growing companies in America. We were stunned at the growth we experienced during the pandemic, as we doubled the size of the company. This is a classic example of where technology meets the challenge of the day.”
Many clients in the life sciences industry during the pandemic were trying to develop new therapies to address the COVID-19 epidemic. Companies needed to automate their validation processes to ensure regulatory compliance which OnShore was able to provide. Since the pandemic, ValidationMaster has grown substantially and OnShore is fast becoming the best solution to address life sciences companies’ validation and verification needs.
Prior to her tenure as CEO of OnShore Technology Group, Valarie King-Bailey worked for several leading global companies including QUMAS Limited (Ireland), EMC/Documentum, Abbott Laboratories, and U.S. Steel – South Works. At QUMAS, she was employed as Chief Marketing Officer and was responsible for all global strategic marketing initiatives as well as the development of their validation toolkit. Valarie also made significant contributions at Abbott Laboratories in Chicago where she served as Director of Document Management and Quality Systems and launched a division-wide validation initiative. For her exceptional performance, Valarie received Abbott’s Chairman’s Award, the highest global award bestowed on an employee, for two consecutive years.
In 2024 and beyond, OnShore aims to expand the use of AI and machine learning to further streamline and improve its validation processes. Its product roadmap has been designed to deliver ValidationMaster to audiences beyond the life sciences market. OnShore seeks to build a digital validation platform for the future. Amid changing regulations and technological advancements, the firm will continue to ensure regulatory compliance and quality as its clients undertake lifesaving work to maintain the health of their patients.
With its comprehensive suite of offerings, OnShore aims to become a leader in the global life sciences software industry. Its turnkey solutions and expert services are designed to accelerate validation processes and project delivery while saving clients’ time and money. Throughout its 20-year history, OnShore has remained steadfast in its commitment to service excellence and ongoing innovation to provide the highest quality of offerings to customers. We are excited to see how OnShore will continue to innovate using AI and machine learning to optimise its validation processes. OnShore Technology Group has received our award for this year’s Leading Innovators in Life Sciences IV&V Software.
For business enquiries, contact Valarie King Bailey from OnShore Technology Group on their website – www.onshoretech.com / www.validationmaster.com
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