Software validation is a methodology supported by global regulatory agencies to confirm that software applications meet their intended use. For life sciences companies, enterprise technologies, mobile or cloud-based applications are subject to a rigorous validation process to ensure that they consistently and repeatedly produce the same data over the course of their operational lifecycles. OnShore Technology Group (“OnShore”) was founded in 2004 as a multinational independent validation and verification (IV&V) company with a focus on the creation and provision of cutting-edge goods and services that support lean validation procedures. Lean validation was pioneered by the OnShore, along with its principles and best practices. One of OnShore’s innovations is its distinctive “Lean Validation” methodology. Lean validation is the fusion of automation coupled with 21st-century best practices for validation.
OnShore Technology Group is a pioneer in the field of IV&V. OnShore’s founder, Valarie King-Bailey, was the 2021 recipient of the IVT Kenneth G. Chapman award for her innovative and noteworthy contributions to the validation field. The award is the Institute of Validation Technology’s (IVT) highest honor.
OnShore uses artificial intelligence and machine learning (AI/ML) to automate the testing process; delivering accurate, high quality software to life sciences companies. OnShore is the FIRST company to use AI/ML for validation.
The Beginning
In 2004, Valarie began exploring opportunities, and stepping out of her comfort zone. She had experienced great success during the course of her 23-year corporate career and had always dreamed of starting her own business. Valarie wanted to start and grow a business offering products and services that were ready for the market. She shares, “It was a scary thing, stepping out initially, but that’s exactly what I did.” “From that day to this, I haven’t looked back.”
Access to capital was Valarie’s first obstacle when she launched OnShore. To open the offices and hire employees required funding. Finding the initial funding to support growth is always a major challenge for small businesses, and it is especially difficult for businesses owned by women and minorities. She applied for funding at her neighborhood bank. The bank declined because of the inability provide financial information or company history on the new business. Valarie needed about $50,000 in funding. The VP of small business banking at another local financial institution agreed to hear Valarie’s presentation. She shared how she planned to use the initial funding thanks to a “Use of Funds” statement. The banker was greatly intrigued by Valarie’s pitch. They inquired, “What could you do with $100,000?!” The bank loaned her $100,000.00 literally about a month after the start of the company. She states, “I used the initial funds to hire two full-time employees and setup our corporate offices. That was the initial impetus we needed to grow the company and the rest, as they say, is history.”
Before the pandemic reached its peak in 2020, OnShore had expanded into a multimillion-dollar business. To advance to the next level, the business utilized of “REVENUE-BASED FINANCING (RBF),” a cutting-edge financial tool. RBF is a unique combination of a bank loan and venture capital. Founder’s First Capital Partners and Novel Partners are the businesses providing this creative funding. Following an effective investor pitch to both businesses, both companies gave Valarie $500,000 each, to support the next phase of growth. The funding was crucial and arrived just as the pandemic was starting. Instead of the company losing money during the pandemic, the funding was the rocket fuel needed to accelerate growth. Revenue-based financing has been an excellent financial vehicle for OnShore and is a SIGNIFICANT contributor to its overall success.
Leading with Innovation
OnShore distinguishes itself from its competitors by not being a “ME TOO” company. Valarie states, “We don’t look at what our competitors do per se, but we look for a better way through innovation. We differentiate ourselves within our software by delivering innovative solutions that help customers do more with less.”
An example of this is the latest AI/ML that Valarie has added to its enterprise validation management platform. Valarie says, “Our competitors’ approach was to automate old, existing paper-based processes.” We took a more innovative approach; leveraging artificial intelligence and machine learning to fully automate the test script development and execution process. Our test scripts are generated by the system, which uses machine language to learn the software application.”
Previously, validation engineers would have to learn the software and then develop the test scripts. OnShore’s innovative TestMaster™ module within ValidationMaster™, changes the paradigm. Its system learns the application the more you use it. The more you use the application, the more intelligent TestMaster™ gets. Valarie asserts, “We are the FIRST to offer our clients “self-healing” test scripts. If a new software version comes out TestMaster™ looks at the new version and determines what the differences are and it actually changes/updates the scripts on the fly itself. This saves about 70 to 80% in the test script development process. This represents significant savings for our clients.”
Valarie states that as OnShore’s competition remains in the old, paper-based world, OnShore Technology Group is moving its clients into 21st-century best practices and to a level of automation and compliance mastery that is second to none.
Seizing Opportunity during Adversity
For some businesses, the pandemic was probably the worst thing to ever happen to them. During the pandemic, a lot of small businesses had to shut down, forcing employees to lose their jobs. Despite the availability of loans like PPP, many small businesses were unable to survive.
During the pandemic, OnShore experienced a surge in business due to the activity among life sciences companies in response to the crisis. OnShore supports the life sciences market. Life sciences companies are governed by the U.S. Food and Drug Administration (FDA), and include pharmaceutical, medical device, biotechnology, vaccine, nutraceutical and many other firms. For the United States, the pandemic exposed a number of difficulties. One of the first things that our government began to wrestle with is PPE for hospitals and caregivers dealing with those afflicted by the pandemic. The second thing that the nation grappled with was finding a vaccine and a cure for COVID 19. Vaccines usually take years for research and development, and at the time, no one believed the vaccine would be coming our way anytime soon.
In March 2020, Valarie’s phone literally began ringing off the hook. Life sciences companies around the world were developing and pursuing vaccines, personal protective equipment, and other supply chain efforts in the pursuit of delivering and managing pandemic-related processes. It is a mandatory requirement that if a company is going to deliver vaccines, hand sanitizer, PPE, and other tools used to support the pandemic, the computer systems used in the development MUST BE VALIDATED. Talk about being at the right place at the right time! The demand for validation skyrocketed during the pandemic. OnShore’s revenues actually doubled during the pandemic, and business remains brisk.
During the pandemic, automation was considered more as a necessity than a luxury. Pre-pandemic technology was regarded more as a luxury than a necessity. OnShore began to reach out to those organizations who required its products and services. Very quickly, the team discovered that it was shorthanded. Responding to the demand, Valarie hired four new validation engineers during the pandemic. OnShore Technology Group began to grow during the pandemic. She shares, “We were fortunate enough to buck the trend because our products and services were right in the middle of what was needed during the pandemic. Our customers were the ones on the front line, such as Moderna, delivering vaccines to patients during the pandemic.” One of OnShore’s customers, Best Sanitizers, was only operating at one shift prior to the pandemic. They quickly moved to three shifts during the pandemic because of the demand. There were many others similarly situated. Whereas the pandemic was catastrophic for many, during the pandemic OnShore flourished.
Extending Limits
Valarie believes that OnShore Technology Group has a promising future. As the business expands, it will continue following the path of innovation to offer goods and services that assist life sciences companies in quickly bringing new products to market. In order to help businesses to better utilize mobile applications to advance patient health systems and other similar technologies, OnShore will be adding mobility applications. Valarie shares, “We will continue expanding on the use of artificial intelligence in testing. We believe that testing is essential to ensure that the software applications used by those who are developing advanced therapies consistently and repeatedly work as designed.” She further adds that the company will be expanding its testing platform to various OTHER industries that are highly regulated. “We will be looking at FinTech, healthcare, and many other industries that could perhaps capitalize on the use of our applications,” Valarie says.
OnShore Technology Group has limited experience with government agencies. It is an MBE, DBE, and WBE certified company. In the near future, it will seek to diversify into the public sector. Every year, the government spends over $3 trillion on services, including validation services. OnShore will start to expand into this market and look for collaborators and competitors who can support its success. There are many opportunities ahead for OnShore Technology Group, and management is eager to seize the opportunity to grow the company’s market reach as well as its presence in new markets.
About the Leader
Valarie King-Bailey is a fierce STEM advocate who has always been philanthropic and believes in giving back to her community and beyond. Valarie has established the OnShore Technology Group Foundation. It is well known that STEM professions are underrepresented among women and minorities. When Valarie was growing up, she was not initially exposed to STEM professions until late in her high school career. Valarie seeks to expose STEM professions to minority and female youth across the country. Each year, Valarie provides scholarships and technology to students that pursue STEM professions before and after graduation.
During the pandemic, many minority students did not own laptops for distance learning. The OnShore Technology Group Foundation provided laptops and tablets to allow students to participate in classes during the pandemic. The mission of the foundation is to help provide a level playing field with respect to technology among female and minority students.
