The ultimate goal of every life sciences organization is to strike a perfect balance between quality, efficiency and compliance. In today’s market, there is no margin for error. Achievement of these goals requires a lean approach. A significant paradigm shift is under way and many organizations are increasingly relying on the principles and best practices of lean validation. Lean validation couples 21st century best practices for software assurance and quality with automation designed to streamline and optimize results. With lean validation, it is possible for life sciences organizations to deliver streamlined and optimized validation processes with minimalwaste.
OnShore Technology Group is a Chicago-based Independent Validation and Verification (IV&V) firm. Their portfolio of products and services are designed to accelerate, automate and optimize validation processes for global life sciences companies.
Founded in 2004 by CEO Valarie King-Bailey, OnShore Technology Group has pioneered and coined the term “lean validation” – a methodology designed to streamline, optimize, automate and transition previously manual, paper-based process into automated paperless and efficient procedures; saving both time and money. Their flagship product, ValidationMaster™, powers lean validation and is the first Enterprise Validation Management and Quality system that delivers a single source of truth for validation project assets. In a book written by Jim Collins, “Good to Great”, he describes a Hedgehog concept.
We pride ourselves on helping our clients accelerate their business.
The principle of the Hedgehog concept is to determine the focus of the business required to drive it from a good to a great company. The concept basically states that companies should have a deep understanding of the intersection of 3 circles – (1) What are you deeply passionate about, (2) What can you be best at in the world, and (3) What drives your economic engine.
For OnShore, establishing their hedgehog concept was their initial challenge. OnShore began operations as a basic IT managed Services Company with many service offerings and upon discovering their hedgehog concept, transitioned into a world class, singularly focused IV&V firm.
The second challenge was something common to all small businesses: raising capital to fund initiatives. Once the company established their IV&V product and services vision, they made the determination that through organic growth, they would fund their initiatives to build their first software application. In the early years, OnShore’s strategy was focused on delivering as much service revenue as they could to fuel growth. They established partnerships with leading companies such as Microsoft, Armanino, Alithya, Hitachi, RSM McGladrey and others to help drive sales and growth. This strategy proved successful and the OnShore team was able to develop ValidationMaster™ using its own operating capital.
With their dedication to provide customers with the best products and services, OnShore has been the recipient of various awards. These awards are not just a pat on the back, but include repeat business from all of their happy customers and recognition from key industry magazines and analysts. Some of these include:
Make Mine A Million Dollar Business Award
OnShore Technology Group was selected from among 600 woman-owned businesses in a nationwide contest as one of 20 finalist enterprises with the potential to reach $1MM in annual sales.
2017 CV Magazine Best IV&V Automation Solutions Provider And Best Validation Testing Experts
Recognition by CV Magazine for ValidationMaster™ Enterprise Validation Management and our lean validation services.
2005 Black Enterprise Magazine
OnShore was featured twice in Black Enterprise Magazine, highlighting client success stories and our unique challenges and achievements operating as a black-owned technology and engineering company.
The Growth Factor-
There were two key factors that triggered the growth of the company: (1) Finding the Hedgehog Concept which resulted in the development and delivery of targeted products and services for IV&V and; (2) Development of the “Validation Accelerators” which addressed the market need to quickly and efficiently validate cloud and mobile technologies and automate the process.
A key consideration in the growth of any company including OnShore is targeting your market with the right products and services that are in high demand.
This is exactly what the OnShore team accomplished in examining their Hedgehog Concept. They listened to the market and understood that the market not only wanted validation services, but many were looking to adopt advanced cloud, mobile and enterprise technologies and needed a way to quickly, efficiently and cost-effectively accomplish this while sustaining compliance.
“Finding our Hedgehog Concept was the key to our rapid growth. We examined our products and services and began to tailor them specifically to address the problems from our clients’ perspective.” When the OnShore Technology Group team first introduced ValidationMaster™ to the market, they sold it as an enterprise software application. The software was not initially bundled with any services or built-in validation documentation. Based on market feedback, they concluded that their clients were looking for an enterprise system to drive efficiency and compliance, while adopting advanced mobile and cloud technologies. OnShore developed a strategic market offering that delivered ValidationMaster™ as part of a total solution called the “CloudMaster 365 Validation Accelerator”.
The 3-part Validation Accelerator includes ValidationMaster; a comprehensive set of user requirements and a full set of “ready-to-execute” validation test scripts. In addition to these 3 components, the accelerator includes all of the validation planning and summary documentation required for clients to help them accelerate their validation processes. They could literally hit the ground running with the “Accelerator”.
This has proven to be a tremendous success for our clients and our strategic growth.
It is time for life sciences companies to adapt to change and to deliver life-saving therapies, medical devices, nutraceuticals and other products to serve their clients. In the process of doing so, they must also keep up with regulatory mandates as they adopt the latest technologies to fuel the growth of their businesses. OnShore helps companies to sustain compliance while achieving their corporate missions.
The Products and Services-
“One of the key differentiators for OnShore is our suite of products and services.”
The company offers several products and services focused on lean validation. Their branded services are Right-Sourced and designed to provide the right resources for the right project at the right time.
ValidationMaster™ Enterprise Validation Management and Quality System
ValidationMaster™ is a cloud-based system designed to manage the full lifecycle of any validation project and quality processes. The application features requirements management, incident management, enterprise quality management, document management, and a full-featured automated test engine to drive automated validation testing. Testing is the most laborious part of computer systems validation thus validation helps to streamline and optimize the testing process. Based on the Microsoft technology foundation, ValidationMaster™ is coupled with a SharePoint-based portal designed to facilitate electronic document workflow and quality processes including audit management, change management, CAPA, nonconformance’s, quality risk management and many other key quality processes.
- ValidationPro℠ IV&V Professional Services: ValidationPro℠ is a full-service, turnkey validation service offering. Through this service, OnShore develops and delivers all validation documentation in accordance with regulatory requirements. Each engagement results in a fully validated system ready for production use. This unique service offering delivers three validation engineers to execute each validation project in a compliant manner for the customer.
- ValidationCoach℠ IV&V Training, Coaching and Mentoring Services: ValidationCoach℠ is a unique service; offering compliance training, coaching, and validation mentoring services. The product is designed to help companies understand and adopt the latest best practices with respect to validation processes and methodologies. The company offers auditing services to audit internal processes and helps customers adopt best practices to mature their validation and quality processes.
- ValidationOffice℠ IV&V Staffing Services: In some cases, a client will seek qualified external resources that understand validation processes and current best practices,and, can also engage in a staffing business model. ValidationOffice℠ delivers expert validation resources on demand for placement on site at customer locations. This unique service offering delivers selection, recruitment, and placement of qualified IV&V engineers to fulfill client requirements on demand.
As we experience continued growth, the strategy for taking the company forward is the continued innovation of our products and services as well as sustained delivery of excellent products and services.
A clear focus on the needs of our customers is the key to continued success. OnShore will continue to listen to their customers, to enhance our understanding of their requirements and continue to deliver products and services that meet their regulatory and business needs.
Leading the Way-
Valarie King-Bailey, M.B.A.
Valarie has over 34+ years of international experience in the life sciences technology industry. Valarie is a Civil and Environmental Engineer by degree with an MBA in Information Systems.She presently serves as the CEO of the Chicago-based IV&V firm, OnShore Technology Group. Valarie started her career in engineering as an environmental and design engineer. She later transitioned to the high-tech sector in 1984 and worked for several software companies including Intergraph, Documentum, and Qumas Ltd in Cork Ireland. With each progressive position, validation became a common thread throughout her career.
Her career graph is accentuated with awards and honors for outstanding performance. Some of these include:
- 2005 – Nominated For Ernst & Young Entrepreneur of the Year Award.
- 2008 – Received University of Wisconsin College of Civil and Environmental Engineering Distinguished Alumni Award.
- 2008 – Received the Madam CJ Walker Outstanding Business Achievement Award.
- 2010 – Received University of Wisconsin College of Engineering Life-Time Achievement Award.
- 2015 – Received the ‘Speaker of the Year’ Award From the Institute of Validation Technology (IVT).
- 2016 – Recipient of the ‘MBEs Who Rock’ Award From MBE Magazine.
- 2017/2018 –Technology Innovation Award From CV Magazine.
To grow healthy sustainable businesses requires the management of human capital which without, there would be no sustained growth.
The OnShore team operates in a collaborative work environment. Their team members each have over a decade of validation experience. They promote open communication and a nurturing environment where the employees are encouraged to learn. OnShore also offers flexible work environments allowing employees to work from home or in the office.