Digital Solutions | GxP Compliance Cloud Computing

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

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

We work with digital technologies like Cloud Computing, Platform-as-a-Service, Purpose Built Applications, Mobile Platform, and Artificial Intelligence 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 product, services, markets, and business models. We then translate these strategies into specific initiatives and projects that allow your enterprise to deploy data, applications, technology, and capabilities through value-driven roadmaps that drive successful execution.

Why Digital Transformation is Important

Digital transformation unites people, business, and technology through the power of the internet. While the details of a digital transformation for your organization may seem to be a lot, our professional team has helped hundreds of companies - just like yours - move from archaic systems of logging information to cloud-based, FDA and EMA compliant solutions.

How USDM Helps with Digital Transformation Strategy

The foundational element of any digital transformation journey is to identify a set of business initiatives and drivers that benefit from new strategic opportunities afforded by cloud and emerging technologies. The emphasis must be using technology to transform businesses rather than just adding bells and whistles to existing processes.

We, as a society, have embraced digital solutions. This digital transformation can affect your core business and open new possibilities, but it requires a foundational change to drive desired results.

At USDM, we combine business strategy, life sciences domain expertise, and new technology to help accelerate our customer's digital transformation journey and achieve cost-effective, high-impact business outcomes. We can create an integrated, single, enterprise-wide view of your compliance risk for your pharmaceutical manufacturing company. We can help you achieve a digital-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 capabilities to predict critical events, and associated risks to ensure compliance, profitable growth, and better customer experience.

IT Roadmap

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

Change Management

As change management experts, we offer services to implement strategies for accomplishing change, controlling change, and helping people to adapt to change. We’ll help you along the entire process of implementation, including organizational change management for your new software, helping build training materials, and making the most of your new digital transformation strategy.

Program Management

We also offer structured program management services to ensure your organization achieves the best business outcomes. We can help with things like; managing your project scope, schedule, stakeholder communication, status reports, and budget management. We can also drive technical project management, including; system testing, configurations, validation, and escalating of technical issues that need further decisions.

Let’s work together to move your life sciences company to modern digital solutions. Contact us today.

Digital Transformation Implementation Services

We work with several, best in class, digital transformation partners, and jointly develop solutions that meet the ever-evolving quality, compliance, and regulatory demands of the life sciences industry.

Software Installation for Pharma & Biotech

Updating your life science organization to modern software and technology can help with greater collaboration, faster access to critical data, and get your products to market faster. USDM can help you install and maintain software solutions that work harmoniously with your existing biotech and pharmaceutical applications or consolidate and optimize your systems to decrease your IT spend.

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

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

Box - Cloud-Based Content Management, Workflow and Collaboartion

Box provides powerful content management with custom integrations and scalable delivery through a complaint-ready content management system. Implementation service includes:

System configuration through the administrative console
Initial validation and on-going, continuous GxP cloud compliance through USDM Cloud Assurance
Integration with other cloud applications
Box consulting

DocuSign - CFR Part 11 Compliant Electronic Signature System

DocuSign provides an excellent solution for customers to enhance workflows by adding electronic signature and digital signature capabilities, including Part 11 compliant e-signature solutions that bolt onto a myriad of other GxP applications. Implementation services include:

System configuration through the administrative console
Initial validation and on-going, continuous GxP cloud compliance through USDM Cloud Assurance
Integration with other cloud applications

We also have other partnerships and software solutions for pharmaceutical companies, medical device manufacturers, start-ups, and other life science organizations. See our partner list.

To explore software solutions for your company’s digital transformation, contact USDM.

Data and Analytics

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

Data Management

Data Governance
Master Data Management & Data Quality
Big Data & Data Lakes

Data Science and Analytics

Machine Learning & Advanced Analytics
Automation & Optimization
Visualizations & Dashboards
Microservices & DevOps

Artificial Intelligence

Machine Learning (ML) / Deep Learning (DL)
Explainable AI
Natural Language Processing (NLP)
Robotic Process Automation (RPA)

USDM Quality Cloud (Powered by ComplianceQuest)

We offer a suite of pre-configured quality management solutions designed to drive the digital transformation of quality and compliance for life sciences customers.

Fast-track: Fully configured document management solutions based on industry best practices
100% Native Cloud: Built on world-class Salesforce platform and powered by ComplianceQuest Enterprise Quality and Compliance Management Systems
Industry Best Practices: Built-in best practices and inclusive of all required documentation to accelerate the deployment and adoption of the system
Customizable: Provides flexibility and configurability to meet additional customer-specific requirements
Future-proof: Designed for the continually changing regulatory environment and scaled to grow with your enterprise

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.