Driving Productivity in Life Sciences

Our special interview with VALARIE KING-BAILEY, award-winning engineer, technology executive and CEO of OnShore Technology Group, Inc, shines a light on the work of Chicago’s leading independent validation and verification (IV&V) firm. Executive Global explores how they are engineering success.
 

Executive Global: Tell us about your ValidationMasterTM solution? 

VKB: OnShore Technology Group is a global Independent Validation & Verification (IV&V) company. We target the life sciences industry.
ValidationMaster is the FIRST lean Enterprise Validation Management and Quality system designed to streamline and optimise validation processes. The need for this solution is years in the making. Validation has historically been a very laborious, manual, paper-based process. As life sciences industries continue to adopt advanced technologies such as cloud, mobile and AI, the need to accelerate the validation process while ensuring sustained compliance is greater than ever. The ValidationMaster system is a full-featured system that includes everything you need to validate today’s enterprise systems. ValidationMaster can be used for ANY type of validation process including computer systems validation, equipment validation, process validation, facility validation, cold chain validation and much more. The system is “application-neutral” and may be used to validate any system within life sciences companies.
 

EG: And as the market leader with the very first fully integrated Enterprise Validation Management system, what impact did your innovative solution have on productivity from within the life sciences industry? 

VKB: ValidationMaster has had a profound impact on the productivity of validation engineers across the globe. As an example, we specialise in the validation of Enterprise Resource Planning (ERP) systems such as Microsoft Dynamics 365, Oracle e-Business, SAP and others. These systems are quite comprehensive and can sometimes be daunting to validate. We developed a Validation Accelerator for each of these systems which includes three distinct components: (1) ValidationMaster, (2) Comprehensive User Requirements, and (3) Complete set of Validation Test Scripts to rigorously test the system. The pre-preparation of these documents and the automation of the testing process saves our clients over 60% in some cases of the cost of validation saving both time and money.
 

EG: In your professional capacity as an engineer, what would you say are the greatest challenges you have experienced in your career? 

VKB: Companies that are resistance to change. As an engineer, I am a problem-solver by nature. Throughout my 35+ year career, I am constantly thinking of ways to make things better. The challenge for people like me is convincing those who cling to the status quo to move forward. Validation is one of the last areas in IT to automate because many believe that paper-based processes were the only way to ensure compliance. We are changing that paradigm.

EG: You also have an MBA from Keller Graduate School of Management. How would you say your rigorous academic training helped prepare you to excel in the higher echelons of engineering and technology? 

VKB: An addition to my MBA in Information Technology, I am a proud Badger Engineer as a graduate from the University of Wisconsin – Madison. My training at the U.W. as well as my MBA provided the foundation for my ultimate success.   

EG: As an award-winning entrepreneur, what do you feel can be done to encourage more women to enter the field of STEM (Science, Technology Engineering and Mathematics)?  

VKB: This is a subject that is near and dear to my heart. I am a fierce STEM advocate. The key is exposure at an early age. We must encourage young ladies to not be “hidden figures” but to strive to reach their greatest potential. Many women do not pursue STEM professions because they are not exposed to them. This must change to help ensure progress. I will continue to do my best to help.   

EG: How do you see new technologies affecting the marketplace for enterprise software testing in the next decade?  

VKB: Technology is moving at the speed of thought. The life sciences industry just produced a vaccine for a global pandemic in record time using advanced technologies and supply chain applications to deliver the vaccine to patients across the globe. New technologies are facilitators. I am excited to see how new technologies help life sciences companies bring new products to market faster and minimise the potential for adulterated products on the market. I see over the next decade a greater need for software quality as software applications drive mission-critical business processes. Artificial Intelligence (AI), mobility, and other advanced technologies will help drive even greater productivity and efficiencies within the life sciences industry and beyond.   

EG: As an engineer, you have impressively saved companies tens of millions of dollars throughout your career. What can new clients look forward to when working with you?  

VKB: My clients can look forward to continued innovation and a relentless drive for efficiency and compliance. We will continue to seek technology solutions to address the pressing issues of the day while ensuring greater operational efficiencies and sustained compliance.  At OnShore, we will continue to deliver for our clients as they bring new therapies for the benefit of humanity.   EG