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Posted 8th April 2022

The Future of Independent Validation and Verification

For the better part of two decades, OnShore Technology Group has been leading the independent validation and verification industry.

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The Future of Independent Validation and Verification
Onshore Technology

For the better part of two decades, OnShore Technology Group has been leading the independent validation and verification industry. From the outset the company has been met with unprecedented success and, as a result, it has been awarded several titles and over the years it has been repeatedly recognised for its devotion to client-centricity and quality. Increasing its collection, OnShore Technology Group has been awarded Acquisition International’s Best Life Sciences IV&V Software and Services Firm, 2022.

OnShore Technology Group is an independent validation and verification (IV&V) firm that provides software products to life sciences companies. In turn, these services aid companies in meeting the regulatory demands and rigorous requirements to support the full validation lifecycle process. Envisioning a future in of which companies have transitioned to automated lean validation processes, OnShore Technology Group strives to be at the forefront of the change, guiding companies towards streamline processes.

Specialising in the development of products and services that power lean validation processes, the company pioneered the concept, principles and best practices of lean validation. Indeed, OnShore Technology Group provides innovative methods that optimise the process, and, additionally, take the client’s needs into account. The software that supports the company’s methodologies is ValidationMaster – a lean Enterprise Validation Management and Quality system designed to automate manual IV&V processes and drive operational efficiencies that save clients both time and money. In essence, every element of the company is infused with quality, ultimately ensuring that the client receives the best possible service.

Established in 2004, OnShore Technology Group made itself at home in Chicago, Illinois, and over the years has planted offices in California and Massachusetts. Moreover, OnShore Technology Group has a location in Surrey, England. Built upon a wealth of knowledge, the company is the base of an expert team led by founder and CEO., Valarie King-Bailey. King-Bailey has accumulated over 34 years of international experience in the life sciences technology industry, and prior to her stint as CEO, King-Bailey worked for leading global companies such as QUMAS Limited, EMC/Documentum, Abbott Laboratories, and U.S. Steel – South Works.

An alumna of the University of Wisconsin and the Keller Graduate School of Management, King-Bailey also serves as an active member of the American Society of Civil Engineers, Society of Women Engineers, National Girls Collaborative Project for STEM education, Regulatory Affairs Professional Society (RAPS), and is a U.W. College of Civil Engineering Advisory Board Member.

The most important asset to OnShore Technology Group is, of course, its team of devoted professionals. Simply put, the team play a critical role within the company, maintaining all the front-line contact with clients. Henceforth, OnShore Technology Group endeavours to only hire experienced, qualified validation engineers that align with its core values.

Bolstering this aim is the company’s intensive hiring profile, which ensures that all of its validation engineers have deep industry domain experience and the technical competency in the validation and verification process. In addition, OnShore Technology Group works to cultivate a positive working environment. The firm has developed an open and flexible workspace and is dedicated to the success of each and every person that works for the company.

Serving a vast range of clients, it is vital that the team is equipped to undertake a variety of unique needs and desires. OnShore Technology Group operates within the global life sciences industry and collaborates with companies across a variety of sectors – including, pharmaceutical, medical device, biotechnology, and other companies regulated by global regulatory bodies such as the US food and drug administration, Health Canada, and the Japanese Medicines Authority. Across the day-to-day operations, the team works to forge a partnership with the client, resulting in a long-term relationships being developed.

It is through the success of such methods that OnShore Technology Group has been awarded numerous accolades. Both its team and its products have been continuously recognised for their effectiveness and quality. Since its founding, the company has garnered international acclaim. For example, in 2021, CEO Valarie King-Bailey received the prestigious Kenneth G. Chapman Award, which recognizes significant contributions in validation excellence. Furthermore, supplied by the Institute of Validation Technology Network, the award recognises the lasting impact the recipient has made in the field of validation and/or compliance activities in pharmaceutical, medical device, or biotech manufacturing.

Receiving such reputable awards has enhanced OnShore Technology Group’s standing within the independent validation and verification services market – unlike its competitors, its contributions have been recognised and celebrated on an international scale. Similarly, OnShore Technology Group’s unique approach makes it a recognisable face amongst a myriad of indistinguishable companies. OnShore Technology Group coined the term ‘lean validation,’ derived from the principles of lean manufacturing which are designed to streamline and optimize the manufacturing processes. These principles were then applied to the validation project, resulting in OnShore Technology Group’s ValidationMaster™, the FIRST lean validation system on the market. The system is unlike any other, deviating from the traditional paper-based method, instead utilising an agile and digital approach.

The Covid-19 pandemic, however, has inspired a new wave of challenges for the industry. Many of OnShore Technology Group’s clients are in pursuit of vaccines, PPEs, and products to support the fight against COVID. In addition to this challenge, many of its clients are seeking to bring new products to market to save lives, transitioning to remote working, and are seeking to power their businesses through new technologies. As a result, OnShore Technology Group has seen an exponential increase in work. The automation of validation processes is no longer a luxury, but a necessity. The boom in business saw OnShore Technology Group made the 2021 Inc. 5000 list of the fastest growing companies in America.

Going forward, OnShore Technology Group is seeking to expand its internal team and to continue the optimisation of its ValidationMaster™ Enterprise Validation Management and Quality system. Moreover, its primary goal is to continue aiding clients in the development of their businesses’ validation and verification processes. Throughout the next year, there are many projects in the pipeline, including the extension of its product roadmap to include integrations with third-party applications and the further development of the ValidationMaster Academy.

For further information, please visit www.onshoretech.com

Categories: News, Strategy

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