Erin Northington, VP of Emerging Life Sciences at USDM Life Sciences
Implementing the right technology at the right time and having the ability to centralize business operations is critical for many businesses to thrive in this fiercely competitive market. The life sciences industry is no different. Players in this field are leveraging cloud computing, platform-as-a-service, purpose-built applications, and mobile platforms to operate their business seamlessly. However, stringent regulations and the perceived higher cost of ownership often hinder life sciences companies’ goals of embarking on a digital journey.
With a comprehensive understanding of this factor, California-based, USDM Life Sciences (USDM) has excelled at providing consulting services to help life sciences companies implement technologies in a compliant and cost-effective way. For the last 20 years, USDM has been successfully enabling life sciences companies to digitally transform while reducing compliance burdens with their qualified resources, and tremendous industry knowledge. USDM helps clients validate their systems and maintain continuous GxP compliance to ensure they are ready for FDA and global regulatory audits, with their Cloud AssuranceTM managed service offerings. “There are many consulting organizations globally, but very few are as experienced as USDM is in both technology and compliance in the life sciences industry. We help our clients accelerate and optimize their technology to maximize return on their investments. We help many emerging pharmaceutical, biotech, medical device, and medical cannabis companies to establish a risk-based, phase-appropriate, pragmatic IT and Quality Roadmap and to accelerate their journey to commercialization through digital transformation. For commercial life science organizations, we accelerate their move to the cloud, provide domain expertise and best practices for moving GxP applications to the cloud, and manage their entire GxP cloud compliance workload,” says Erin Northington, VP of Emerging Life Sciences at USDM Life Sciences. Furthermore, as a regulatory compliance trusted advisor, the company designs diverse training programs for their clients to help them mitigate risk and increase efficiency while reducing operational costs.
USDM has built strategic partnerships with many renowned Software-as-a-Service (SaaS) enterprises to drive value for their clients, such as Veeva Systems (Veeva), Oracle, Salesforce, DocuSign, and numerous others. Veeva is a cloud-computing company focused on pharmaceutical and life sciences industry applications. USDM has been working with Veeva for the last five years to assist clients in program management, computer systems validation, change management, annual vendor audit, and communication and training to decrease cloud compliance management costs and to speed the implementation time.
There are many consulting organizations globally, but very few are as experienced in both technology and compliance for Life Sciences as USDM. We help our clients accelerate and optimize the technology that they are implementing to maximize ROI on their investments
For example, while implementing Veeva Vault QualityDocs, companies often struggle to understand its functionalities. In such cases, USDM helps clients optimize it to ensure maximum return on investment. “We always keep ourselves updated with new and upcoming Veeva products and functionality to communicate with our clients more intelligently and serve them better,” Erin mentions.
She goes on to mention that many pharmaceutical companies often undertake a wrong approach while opting for digital transformation. They implement technologies that never support their unique business needs. As such, USDM performs an analysis of needs while engaging with a client. This helps them understand the challenges that the client is trying to resolve and suggest solutions accordingly. “All of our team members come from the life sciences industry. We have former FDA auditors, regulatory officials, and experts in all verticals of a life sciences organization that have expertise in quality management, document management, Clinical, Regulatory, Biostatics, Lab, Manufacturing, and ERP systems. With such comprehensive knowledge, these subject matter experts can define the proper solutions for a life sciences organization,” Erin comments.
Perfecting such capabilities, USDM has gleaned a legion of life sciences companies as happy customers. For instance, they frequently help biotech companies successfully launch their first products. For one company, the client was planning for FDA preapproval inspection (PAI). The PAI is a pre-requisite to have a license for commercial manufacturing. To prepare for this milestone, the client needed a learning management system, document management system, and a comprehensive computer system validation (CSV) program and all necessary IT standard operating procedures (SOPs). The timeline for the overall project was also tight , given that the company anticipated FDA approval within a few months. USDM helped the client implement Veeva QualityDocs Electronic Document Management System (EDMS) and a Learning Management System (LMS). “We also helped them in developing and facilitating the training for their QualityDocs system and LMS application,” Erin mentions. Remarkably, everything was completed in 12 weeks. At the end of the project, the biotech company successfully went through the PAI and commercialized their product more rapidly.
With countless unique instances of client success, USDM has drawn a comprehensive roadmap for the coming years with best-in-class SaaS Partners. It will bolster its partnership with Veeva Systems to help clients implement new Veeva solutions. “We’re working to be the voice of the customer with Veeva to lead the movement to a more streamlined Computer Software Assurance (CSA) approach, and be ready for the FDA’s new guidance expected in September 2020. This will accelerate our capabilities in the Veeva space as well,” Erin concludes.