Kevin Brown, Co-founder & Managing PartnerGiven the complex landscape of evolving regulations combined with the rapidly changing life sciences marketplace, chief executives of today’s leading companies are challenging traditional ways of conducting business to ensure a competitive supply chain, promote customer confidence and enable growth. One such area where traditional programs are coming under increased scrutiny for adoption over non-traditional solutions is Governance, Risk, & Compliance (GRC). “Corporate accountability is placing increasing demands on the adoption of a GRC strategy to provide stakeholders the confidence that their business is being run in a reliable, compliant and sustainable manner. A comprehensive GRC program can save time and money by unifying approach to design and implement effective controls and risk mitigation tactics,” says Kevin Brown, co-founder and Managing Partner of US Data Management (USDM).
USDM provides solutions for life sciences companies to tackle GRC challenges. It applies practices to identify GRC threats and build a protective framework of policies, controls, and risk mitigation strategies. In addition, it provides life sciences expertise to integrate FDA computer system compliance into GRC program. The company’s Validation Accelerator Packs streamline the process of implementing computer systems in compliance with GxP regulations and help consolidate the overall enterprise compliance strategy when combined with GRC Manger. USDM specializes in compliance and implementation services in the life science industry. Within this space, the company provides vendor selection, GAP analysis, project management, computerized system implementation and validation, and procedure development to its clients and partners.
USDM addresses the critical areas of operations for pharmaceutical and medical products companies. “We proactively work with clients to identify how to drive higher levels of business performance across the entire product development lifecycle,” says Brown. It implements solutions that support regulatory intelligence and knowledge management throughout the research and development and administrative processes. The company help clients improve the quality, efficiency, and compliance in the development of new medical products; streamline the development of submissions and preparation for interactions with regulators; enhance the quality of information provided in managerial submissions; and accelerate administrative authority review and approval.
We proactively work with clients to identify how to drive higher levels of business performance across the entire product development lifecycle
Information Technology has evolved to become the critical backbone of a life sciences company that helps to produce, manipulate, store, communicate, and disseminate information. USDM consultants provide a variety of services to the life sciences sector that ensure IT compliance while pushing the boundaries of IT innovation. These services include: Network Infrastructure Qualification Services, Virtual Infrastructure Qualification Services, IT Infrastructure Services, IT Compliance Services, and Software Development Services.
Each USDM practice is purely committed to the relative life sciences domain. Its virtualization practice helps support the unique needs of life science companies when applying an advanced approach for managing infrastructure. Content management systems both run the operational processes of manufacturing companies and contain the intellectual property that develops patents to products. “Our Interwoven practices come together to create a powerful, integrated approach to performance and compliance. The USDM’s ECM Practices combined with the Electronic Lab Notebook team meets the objectives for enterprise content- from the lab to records management,” says Brown.
Consider the example of a renowned life sciences company that was facing severe compliance issues. USDM offered them an Enterprise Content Management solution, which enabled them to meet existing and future compliance needs while significantly lowering the overall cost of content management systems.
Looking forward; “USDM will continue to lead the fast growing IT Compliance market in Life Sciences with thought leadership, quality services, and customer satisfaction. To that end, Bill’s 20 years of industry experience and honed expertise will help USDM better serve its customers,” says Brown.