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.
 

Advanced Analytics

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?
Learn more about our USDM’s automation expertise and GxP framework for AI, ML, and NPL.
 

Data Migration

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.

Digital Transformation for Pharma & Biotech FAQs

  • Is healthcare information safe in the cloud?

    Medical facilities and service providers are migrating to cloud storage because it gives users the ability to access data across a variety of electronic devices while reducing the costs and difficulties associated with maintaining a physical or on-premise storage system. Yes, cloud-based systems offer a safe and secure solution to store data, and you must investigate how your cloud provider encrypts data, stores data, and what security standards they practice. Not all vendors are created equal and we can help find the right solution for your data security needs, but we believe the cloud is a necessity to keep up with competitors and grow your business.

  • Does USDM help with regulatory compliance when moving to the cloud?

    Regulatory compliance is at the core of everything we do and differentiates USDM from other consulting organizations. We have been studying the regulatory landscape for over 20 years and even have former FDA employees on staff that wrote the regulations. We take compliance very seriously and understand the many nuances and global regulatory requirements for compliant IT systems. At USDM, we have worked with countless cloud systems and likely have experience with whatever system or application you are exploring. Our goal is to build an ever-evolving community of cloud vendors specialized in life sciences to meet the regulatory requirements of our customers.

  • What software solutions are available for pharmaceutical companies?

    There are many software solutions for pharma and life sciences companies and choosing a vendor can be overwhelming. USDM brings together a community of vendors that meet the requirements needed to achieve the quality and compliance demands of the life science industry. Along with USDM’s Cloud Assurance service, we have solutions for eSignature, CMS, QMS, clinical systems, supply chain/distribution, and more, to establish the foundation for your IT compliance. We have worked with countless applications and likely have experience with whatever system you are considering.

  • What software solutions are available for medical device manufacturers?

    There are many software solutions for med dev and life sciences companies, and choosing a vendor can be overwhelming. USDM brings together a community of vendors that meet the requirements needed to achieve the quality and compliance demands of the life science industry. Along with USDM’s Cloud Assurance service, we have solutions for eSignature, CMS, QMS, clinical systems, supply chain/distribution, and more, to establish the foundation for your IT compliance.

  • We are a lean start-up, what are our options?

    Start-ups and smaller companies can take a more agile approach to unlock value quickly by adopting cloud solutions that enable the business to start small and iterate and scale as the business grows. Large enterprises can take a more structured 36-to-48 months value-driven roadmap to deliver on its goals. We often see start-ups begin with a solution for eSignature (i.e. DocuSign) or digital document management (i.e. Box) or quality management system (i.e. ComplianceQuest) as their first step.

  • What are my options for digital transformation document management?

    Several document management solutions have GxP capabilities for life sciences. We have partnerships with Box, Veeva, ComplianceQuest, and others. It depends on how robust you need your system and integrated functionality to be, and we’d be happy to help make a recommendation based on your unique needs.

  • Is DocuSign FDA compliant?

    DocuSign offers modules to support compliance with the electronic signature practices outlined in the FDA’s 21 CFR Part 11. Their Part 11 module includes Part 11-specific eSignature functionality for authentication, the reason for signature, and signature manifestation. These capabilities help comply with regulations while using eSignature to make executing agreements faster, more cost-efficient, and more convenient.

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