USDM is connecting people, technology, and data in new ways for real-time insights to improve business outcomes.
Whether you are a large or small life sciences company, USDM Life Sciences can implement new and emerging technologies that help you create more value for your customers, employees, and shareholders.
At USDM, we partner with best-of-breed digital technology providers to ensure continuous GxP cloud compliance for our customers. By simplifying compliance burdens and optimizing your technology, we help you evolve into a high-performing, hyper-efficient, modern enterprise.
Our digital transformation approach combines business strategy, domain expertise, and new technology to develop innovative plans for products, services, markets, and business models. This translates to specific initiatives and projects that allow your business to deploy data, applications, technology, and capabilities through value-driven roadmaps that result in successful execution.
Life Sciences Technology Systems
USDM can implement and maintain cloud technology solutions that work harmoniously with your existing pharmaceutical, biotech, and medical device
business applications, or consolidate and optimize your systems to decrease your IT footprint and IT spend.
- eSignature Solutions for Life Sciences
- Quality Management System (QMS)
- Change Management, CAPA, Audit, Complaints, Asset Management, Non-Conformance/Deviations
- Enterprise Content Management Systems and Quality Document Management Systems
- GxP File Retention/ECM/EDMS/QDMS
- Learning Management Systems (LMS) / Training Systems
- Clinical Systems
- eTMF, R&D Collaboration, Clinical Study Startup, Site Feasibility Surveys, SUSAR
- Electronic Lab Notebook
- Enterprise Resource Planning (ERP) Systems for Life Sciences
USDM Cloud Assurance for One System or Many Systems
USDM Cloud Assurance
combines cost savings and risk reduction to manage your technology and compliance processes from end to end so you can focus on other priorities. Whether you need continuous compliance for one system or many systems
, we will take care of everything from hiring and managing the team, to building the processes and procedures, to achieving consistency of your policies across the enterprise, to delivering results.
IS Health Check and IT Roadmap
Conducting an Information System (IS) Health Check will assess your state of regulatory compliance and IS efficiency. We’ll provide a scalable plan to accelerate your IS maturity
while handling your compliance workloads and maintaining GxP cloud compliance
across your enterprise.
To create your value-driven roadmap
, we’ll start by assessing your business needs and your documented and informal processes and procedures. Next, we’ll identify critical systems and document your business requirements. Then we’ll help you to prioritize those systems, develop timelines for implementation, and guide you through vendor selection.
Organizational Change Management and Program Management
As organizational change management (OCM) experts
, we will help you along the entire process of implementation, including for your new software, building training materials
and communication plans, and driving adoption of your new technology
USDM’s program management services
help you to manage your project scope, scheduling, stakeholder communication, status reports, and budget. We can also drive technical project management, including system testing, configuration, validation, and escalation of technical issues. Let’s work together to move your life sciences company to modern digital solutions.
With automation, robotics process automation (RPA), artificial intelligence (AI)
, machine learning (ML), and natural language processing (NLP), life sciences companies have never had more opportunities to realize value from data, yet they are struggling to do so.
AI chatbots interact with people using NLP, but ML is a more advanced type of AI that uses algorithms to learn from data and make predictions.
ML overlaps with computational statistics, predictive analytics, and data mining. All of these are used in the life sciences industry, and some are supporting GxP functions. When it comes to advanced analytics, what is your AI strategy
and how can you benefit from ML, NLP, and RPA technology?
about our USDM’s automation expertise and GxP framework for AI, ML, and NPL.
Simply put, data migration is the process of transferring data between two or more storage types. The transfer can occur between different formats or different computer systems. This is a straightforward concept, but it can get complicated when formatting requirements vary between the source and destination and if this data has regulatory compliance implications.
Migration can take different forms: migrating to or within the cloud, on-premise, from a database or application, or storage-only migration. Whatever requirements you identify, a data migration plan is essential. It is rarely a simple copy; there is almost always data mapping, transformation, or conversion that must take place along with verification.
USDM can help clarify all of this in your data migration plan. Contact us to start discussing your digital transformation strategy.