OnShore Technology Group, a Chicago-based firm specializing in life sciences, has developed lean validation; an optimized validation process. It is designed to help eliminate waste and inefficiencies traditionally found in manual validation processes while streamlining and integrating quality and value to your company. This innovative methodology will ultimately conserve your resources enabling more critical thinking and facilitating more rigorous testing and software assurance. Strategically, lean validation also helps you build repeatable processes that help accelerate the adoption of new technologies that ultimately help life sciences companies bring new products and therapies to market faster.
Validation influences several core facets of the business, from competitiveness to the quality of products. However, manual validation processes are not enough anymore. An integrated, automated validation process is required to ensure success and sustained compliance. This is where lean validation comes into the picture.
We have discovered one notable company that clearly understands the unique challenges within the life sciences and is a pioneer, champion and advocate of validation process automation. We would like to introduce OnShore Technology Group.
The Brief
Established in 2004 by its founder, Valarie King-Bailey, OnShore Technology Group is an Independent Validation and Verification (IV&V) firm. It is dedicated to the development and delivery of innovative IV&V products and professional services for life sciences, government, and other regulated industries.
OnShore is nestled in the heart of America’s midwestern region. With offices and headquarters in Chicago and satellite offices in Boston, California and in Weybridge, UK, the company enjoys a global operating presence. OnShore’s core target market is life sciences which includes, pharmaceutical, medical device, biotechnology, nutraceutical, vaccine, blood companies, specialty pharma, food & beverage, and much more.
OnShore’s core mission is to become the leader in the development and delivery of lean validation products and services. In keeping with its mission, OnShore delivered the FIRST Enterprise Validation Management and Quality System powering lean validation known as ValidationMasterTM. Adopted by leading companies across the globe, the system has filled a persistent void for a total automated solution. The system is designed to streamline, optimize and automate validation planning, requirements management, testing, and document control processes. ValidationMaster™ has succeeded in the delivery a complete 360-degree solution to support the full lifecycle of validation processes.
As the U.S. Food and Drug (US FDA) changes its posture from traditional validation to its new Software Assurance methodology, ValidationMaster™ is recognized as one of the first systems to embrace the principles and best practices to support their new methodology. Through OnShore’s Validation Center of Excellence, the organization is taking steps to enhance the application to drive greater automation and efficiency in the validation process.
“We are pioneers in the development of lean validation principles and best practices.”
One of the critical steps that the firm is incorporating as part of the overall qualification process is Cybersecurity Qualification (CyQ). This new addition is designed to assess the readiness of life sciences companies to identify, protect, detect, respond and recover from potential cyberattacks on validated systems. Furthermore, OnShore is also adding new features to support artificial intelligence in validation testing, CyQ risk assessments, and greater integration with 3rd party applications that deliver value to the validation process. All-in-all, OnShore is heavily concentrated on developing and deploying lean validation strategies that provide a more agile approach for software assurance.
The Leader at Helm
Valarie King-Bailey, Chief Executive Officer at OnShore has over three decades of experience in the life sciences technology industry. She holds an M.B.A in Information Systems from Keller Graduate School of Management and a B.S. in Civil and Environmental Engineering from the University of Wisconsin.
She is also a member of the American Society of Civil Engineers, Society of Women Engineers, National Girls Collaborative Project for STEM education, Regulatory Affairs Professional Society, and U.W. College of Civil Engineering Advisory Board Member.
Valarie is also the founder of the blog ‘The Validation Post.’ She is a frequent guest speaker at the Institute of Validation Technology (IVT) and was honored with the IVT Speaker of the Year award in 2015.
Prior to OnShore, Valarie has worked for leading global companies such as QUMAS Limited (Ireland), EMC/Documentum, Abbott Laboratories, and U.S. Steel – South Works. At QUMAS, an Irish-based software company, she served as Chief Marketing Officer where she was responsible for all global tactical and strategic marketing initiatives in addition to the development of their validation toolkit.
She also made a significant impact at Abbott Laboratories in Chicago where she served as Director of Document Management and Quality Systems, leading a $16MM division-wide validation initiative.
As recognition for outstanding performance, Valarie received Abbott’s Chairman’s Award – the highest honor bestowed by Abbott on its employees by the CEO and Board of Directors. Remarkably, she received Abbott’s Chairman’s award for two consecutive years saving the company over $40MM in annual cost savings.
In 2008, Valarie received the Distinguished Alumni Award from the U.W. College of Engineering in 2008, and in 2010, she received a Lifetime Achievement Award from the U.W. College of Engineering.
The Key Differentiator
OnShore’s 16-years legacy thus far has cultivated an impressive portfolio of state-of-the-art products and services focused on lean validation. The key differentiator for the company is its ability to translate and automate mission-critical validation processes into innovative products and services . In the era of COVID-19, OnShore’s business is accelerating. More than ever, they are helping many life sciences companies to rapidly adopt and validate new technologies and to deliver new therapies that hopefully will result in effective vaccines that combat this deadly virus.
“For over 16 years, we have worked as a trusted partner with our clients as well as many global system integrators and technology companies to help deliver turnkey validated systems and ensure sustained compliance.”
ValidationMaster™ Enterprise Validation Management and Quality System
This is a cloud-based system designed to manage the full lifecycle of validation 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.
As testing is the most laborious part of computer systems validation, ValidationMaster™ helps to streamline and optimize the testing process. Based on the Microsoft technology foundation, ValidationMaster™ is coupled with a SharePoint-based portal. This is designed to facilitate electronic document workflow and quality processes including audit and change management, CAPA, nonconformance’s, quality risk management, learning and competency 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 following 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
A unique service offering compliance training, coaching, and validation mentoring services. It is designed to help companies understand and adopt the latest best practices concerning validation processes and methodologies. The company offers auditing services to audit internal processes and help customers adopt best practices to mature their validation and quality processes.
ValidationOffice℠ IV & V Staffing Services
ValidationOffice℠ delivers expert validation resources on demand for placement on-site at customer locations. This unique service offering delivers selection, recruitment, and emplacement of qualified IV&V engineers to fulfill client requirements on demand.
Besides these excellent services, the key differentiation for OnShore is the lean validation strategies coupled with the automation delivered by ValidationMaster™. “Our lean processes powered through automation delivers unprecedented efficiencies for our clients and streamlines the overall validation process. Another key differentiator is our comprehensive service offerings,” says Valarie.
She continues, “We offer full-service validation and an innovative validation coaching option. Our full-service offering, ValidationPro℠, delivers turnkey validation services to our clients for ANY commercial or bespoke computer systems whether it is cloud-based or on-premise. Our coaching services branded as ValidationCoach℠ delivers strategic expert validation professional services on demand including validation audit management services, SOP development services, validation testing services, validation content management services, and much more.”
“Our leading innovation ValidationMaster™ is the first Enterprise Validation Management System (EVMS) to include a validation Kanban board and seamless integration with our unique ValidationMaster Quality and Risk Management portal.”
In recent times, numerous life sciences companies have favored cloud-based Enterprise Resource Planning (ERP) systems such as Microsoft Dynamics 365, Oracle Fusion Cloud, SAP, and many others. The renewed focus on supply chain technology is driven by the need for many companies to bring new therapies to market to combat COVID-19.
To help companies accelerate new ERP systems to production, OnShore has developed a new Validation Accelerator known as CloudMaster 365℠. This dynamic ERP system delivers a fully automated validation management system (ValidationMaster) with all of the documentation required to help companies succeed and quickly validate new technologies.
Valarie asserts, “Our Accelerator saves clients from 40 – 60% cost savings and streamlines the overall validation process. During the pandemic, this solution has been flying off the shelves!”
Advocating Automation
OnShore Technology Group is experiencing rapid growth. The firm is quite pleased with the market acceptance and momentum of ValidationMasterTM. Moving forward, the company plans to refine its lean validation strategies and drive greater market penetration with ValidationMasterTM.
“Our focus will be to enhance our cloud and mobile offerings to help clients deliver greater efficiencies. We are also working with regulators and industry forums to sharpen our focus on cybersecurity in validated systems environments. Other plans include key partnerships to accentuate our offerings. We are looking to strengthen existing partnerships as well as forge new ones that are compatible with our offerings,” comments Valarie.
Valarie also identifies Automated Testing and Artificial Language to be the latest trends. According to her, the current buzz is focused on AI and ML and prominent contenders in the industry are accelerating on AI-driven services. As software innovation continues to develop, leading software companies are increasing the complexity of enterprise systems. Onshore is ready for all of that.
Valarie says, “The need for more extensive validation testing shall endure. We will be at the forefront of this movement to deliver greater enhancements for validation professionals. We will adapt ValidationMaster™ to embrace these trends.”
“Our lean methodologies are powered by ValidationMaster, the FIRST 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.”
Valarie and the team have also kept their keen eyes on its long-term strategy to prepare the next generation. As such, the team collaborates each year with colleges, universities, and governments advocating Science/ Technology/ Engineering/Math (STEM) professions among today’s youth – especially young women.
OnShore also maintains a scholarship fund for STEM students to enable the brightest student to pursue STEM education. The organization also introduces them to the technology workplace, offers employment opportunities, offsets the costs of their educational pursuits, and ultimately, mentors young people, and gives back to the community.
