Connecting people, technology, and data in new ways for real-time insights to improve business outcomes.

We live in a time when large and small life sciences companies around the globe are attempting to transform themselves with unprecedented new and emerging technologies. Organizations are striving to create more value than ever before for customers, employees, shareholders, and society at large.

At USDM, we work with digital technologies like cloud computing, Platform-as-a-Service (PaaS), purpose-built applications, mobile platform, and artificial intelligence (AI) to help reimagine modern enterprises to drive high-impact business outcomes at a lower cost.

Our Digital Transformation team combines business strategy, domain expertise, and new technology to develop innovative strategies in products, services, markets, and business models. We then translate these strategies into specific initiatives and projects that allow your business to deploy data, applications, technology, and capabilities through value-driven roadmaps that result in successful execution. 

Why Digital Transformation is Important 

The coronavirus pandemic accelerated digital transformation to unite people, business, and technology through the power of the cloud. Your success depends on how quickly and how well you harness this technology to enable your workforce to work from anywhere, build platforms that differentiate your company, and innovate faster than ever before. While the strategy and execution may seem overwhelming, USDM has helped hundreds of companies—just like yours—move from archaic, on-premises systems to cloud-first, Food and Drug Administration (FDA) and European Medicines Agency (EMA) compliant enterprises.

How USDM Helps with Digital Transformation Strategy

The foundational element of any digital transformation journey is foundational change to drive your desired results and USDM helps you to identify business initiatives that benefit from cloud and emerging technologies. The emphasis must be on using technology to transform your business, not just to add bells and whistles to existing processes.
 
  • We can create a single, integrated, enterprise-wide view of your compliance risk for your pharmaceutical manufacturing company.
  • We can help you achieve a cloud-first approach and build a seamless quality and compliance workflow for your startup.
  • We’ve worked with medical device companies to enable deeper data analytics to predict critical events, and mitigate associated risks to ensure compliance, profitable growth, and a better customer experience.
IT Roadmap

We help build your value-driven roadmap with initiatives and projects that allow your enterprise to deploy data, applications, technologies, and capabilities. We start by assessing your business needs and your documented and informal processes and procedures. Next, we identify the necessary critical systems and document your business requirements. Then we help you to prioritize systems, develop timelines for implementation, and guide you through vendor selection.

Change Management

As change management experts, we will help you along the entire process of implementation, including organizational change management for your new software, building training materials and communication plans, and driving adoption of your new technology.

Program Management 

USDM’s structured 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. Contact us today.
 

Digital Transformation Implementation and Cloud Compliance Services

We work with several, best-in-class technology partners, and jointly develop solutions that meet the ever-evolving quality, compliance, and regulatory demands of the life sciences industry. USDM can implement and maintain cloud software 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.
 

USDM Cloud Assurance for One System or Many Systems

USDM Cloud Assurance combines cost savings and risk reduction to manage your technology and compliance process 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. Let us conduct an IS Health Check to assess your state of regulatory compliance and IS efficiency. We’ll provide a rapid, scalable plan to accelerate your IS maturity while handling your compliance workloads and maintaining GxP cloud compliance across your enterprise.

Box - Cloud-Based Content Management, Workflow, and Collaboration
Box provides powerful content management with custom integrations and scalable delivery through a compliance content management system. Implementation service includes: 

ComplianceQuest - Quality Management System Software
ComplianceQuest provides a suite of Enterprise Quality Management System (EQMS) applications to significantly improve culture, collaboration, performance, and innovation by driving digital transformation via the Salesforce platform. Implementation services includes: 

  • Digital document management  
  • Training management 
  • ​Change management 
  • Non-conformance/deviation management 
  • CAPA management 
  • Complaints management 
  • Incident management 
  • Inspection management 
  • Supplier management 
  • Risk management 
  • Audit management 
  • ​Equipment management   

DocuSign - Part 11 Compliant Electronic Signature System
DocuSign is an excellent way for customers to enhance workflows by adding electronic signature and digital signature capabilities, including FDA 21 CFR Part 11 compliant e-Signature solutions that bolt onto myriad other GxP applications. Implementation services include: 

Salesforce - Cloud-based CRM
Salesforce provides the leading CRM solution with a suite of GxP applications that offer unmatched configurability. You can easily extend Salesforce to GxP areas like clinical, quality, and other regulated areas. Implementation services include:

  • Regulatory Information Management System (RIMS) 
  • Product Registration Management (planning roadmap, notification of change, etc.)
  • Workflow-as-a-Service to add new business use cases with compliance built in
We have other partnerships and software solutions for pharmaceutical companies, medical device manufacturers, start-ups, and other life sciences organizations. See our complete partner list.
 
To explore technology solutions for your company’s digital transformation, contact USDM.
 

Data and Analytics 

USDM is assisting clients with advanced analytics to experiment, innovate, and deploy cloud-based solutions. Our support addresses data quality, people, risk management, and processes.  

Data Management  Data Science and Analytics  
  • Machine learning and advanced analytics 
  • Automation and optimization 
  • Visualizations and dashboards 
  • Microservices and DevOps 
Artificial Intelligence   

Unify Compliance Cloud

Unify Compliance Cloud is an innovative quality suite that enables quality document management, quality change management, and training to significantly improve collaboration, control, and visibility over your quality management processes. Unify Compliance Cloud expands internal and external supplier quality while delivering continuous regulatory compliance. Working together, Box, ComplianceQuest, and USDM provide a solution to fast-track your digital transformation of quality and compliance in the cloud.

  • Bundled solution with best-of-breed stack in a single deployment (100% remote)
  • Pricing is for entire platform solution, not by use case
  • Flexible, open API platform with 1400+ integrations and process automations
  • Faster deployment and adoption of document management, change management, and training solutions
  • Enterprise-grade security delivered through a modern cloud platform
  • Continuous compliance with USDM’s Cloud Assurance
  • Zero IT footprint with 100% native cloud applications deployment
  • Easy collaboration for both internal and external users
  • Add use cases and scale as your business needs evolve
 

Unify Public Cloud

USDM enables pharmaceutical, biotechnology, and medical device companies to transform their GxP workflows with Unify Public Cloud. USDM's solution for regulated workloads in the public cloud covers end-to-end technology and compliance solutions to address business applicationscloud services, and global infrastructure.

  • Reduce your compliance risk and achieve continuous cloud compliance with USDM’s framework and accelerators for Azure
  • Speed deployment and adoption of Azure and Microsoft business applications with prepackaged solutions built on life sciences best practices
  • Accelerate your cloud journey by identifying strategic business initiatives made possible with Azure
  • Flexible cloud adoption model to migrate regulated workloads
  • Cost-effective, bundled solution to minimize barriers to compliance and innovation
  • Build value-creating activities and decrease value-consuming activities
Read our white paper to learn more about Unify Public Cloud.
 
Contact USDM today 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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