Technology Innovator Awards 2017

, “To keep abreast of the ever- changing world of independent validation and verification and advanced technology, we attend many industry forums and keep up with the latest global regulatory guidelines. We are partners with market leaders such as Microsoft, Oracle, SAP, and many others. To stay ahead of the game, we leverage our Validation Center of Excellence (VCoE) to test and confirm many of the latest technologies before recommending them to our clients. We endeavor to ensure that we work with only the highest quality technology vendors in the application of the their technologies to the IV&V processes we support.” Cybersecurity is a key issue affecting many industries, including both the technology and life sciences spaces, which OnShore Technology Group both operate in and support. As such, the company is committed to tackling this issue and supporting clients to overcome the myriad of challenges they face, as Valarie explains. “Although we deliver products and services globally, our company is based in the United States. The key challenges we face with respect to validated systems include cyber security and the validation of advanced cloud-based enterprise applications. Cyber security is an ever- present threat for companies of any size within any industry. Validated systems have a unique challenge to address when it comes to cyber security vulnerabilities in that life sciences companies must maintain the validated state overtime. Also, many companies in life sciences are embracing cloud applications which provide unique challenges in terms of outsourcing the responsibility for system infrastructure, validation change control and maintaining the validated state overtime in the cloud. Finally, many life sciences companies are embracing mobility to drive compliance processes across the enterprise. Mobile technologies provide a unique challenge for validated systems as well including how to effectively test them and maintain them in a validated state. “Therefore mobility, cyber security, and the cloud are changing the way today’s enterprise systems are validated in life sciences companies. OnShore Technology Group has developed innovative strategies, products and services designed to specifically address these challenges and help our customers maintain validated systems over time. “An example of what we are doing in the industry to address these unique challenges is our unique approach to the qualification of validated systems. Many of our clients are familiar with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). OnShore Technology Group is the first company to pioneer the use of a cyber security qualification (CyQ) designed to include a cybersecurity risk assessment, identification and prioritization of security gaps and controls, and testing to mitigate cybersecurity vulnerabilities and risks. The goal of the CyQ is to maintain data integrity throughout the life of the system and to protect and defend validated systems environments. We are the only company in the market that is directly addressing the threat of cyber vulnerabilities to validated computer systems.” This focus on supporting clients through these challenges will remain the firm’s ongoing focus as it looks ahead, as Valarie highlights. “Currently we are working with leading technology companies to develop and deliver innovative solutions to the market. Cyber security is changing the face of validation and impacting it in ways that are unprecedented. We are at the forefront of addressing these industry trends with market-leading solutions and services.” Looking further ahead, Valarie has many ambitious plans to drive success for clients and help OnShore Technology Group thrive. “Overall, we look forward to the future with great anticipation. Although technology has advanced at the speed of thought, IV&V processes have remained manual, paper- based and stagnant over the past 40 years. As life sciences companies continue to deliver innovative therapies to address current health challenges, we will assist them in ensuring that their validated systems environments and mobile technologies are production-ready and of the highest software quality. “Given the changes in the way software is developed, implemented and deployed across the enterprise, we believe IV&V processes must keep up with these changes over time. OnShore Technology Group is an IV&V pioneer and at the forefront of these changes. We will continue to provide expert validation services across the globe as well as the continued enhancement of ValidationMaster. “It is our ultimate goal to expand beyond the life sciences industry to address other highly regulated industry sectors such as technology, nuclear, government, tobacco, and many others where IV&V is a mandated process. In each of the industry sectors it is our goal to understand their unique challenges with respect to IV&V and quality testing and provide solutions that uniquely address their requirements leveraging our advanced technology services and solutions. We will continue with the perfection of our Lean Validation strategy in an effort to continue the optimization of the processes and overall reduction in the cost of IV&V service delivery. We look forward to leading the way with 21st-century independent validation and verification products and services that save our clients both time and money.” Contact Email: [email protected] Address: Lake Point Tower Renaissance Plaza, 505 N. Lake Shore Drive, Suite 220, Chicago, Illinois 60611, USA Phone: +312-321-6400 Website: onshoretech.com/ & validationmaster.com/