Compliance Simplified

USDM Cloud Assurance: End-to-End GxP Compliance

Case Study

Biopharma Company Saves $500k by Qualifying Salesforce

USDM Cloud Assurance simplifies GxP compliance and accelerates innovation with a continuously compliant tech stack.

USDM’s Cloud Assurance^TM is a managed service subscription delivering end-to-end GxP compliance including rapid implementation, GxP validation, and maintenance to enable a continuously compliant tech stack. USDM Cloud Assurance is the compliant digital platform for GxP cloud-based technologies of any size or complexity. Whether you have a single cloud application needing continuous GxP validation or a multi-cloud system portfolio, Cloud Assurance will scale to meet your needs and deliver a harmonized compliance framework that decreases your time and cost to maintain GxP compliance.

With more than 200 life sciences companies subscribed to USDM’s Cloud Assurance platform, you can have confidence in our best practices based on more than 20 years of life sciences GxP compliance experience.

Cloud Assurance Benefits

USDM best practices, accelerators, and automation significantly decrease your implementation, GxP validation, and maintenance effort to simplify your deployment and adoption.

USDM expertise provides you with accelerated speed and scalability, better configurations, improved workflows, optimized use cases, organizational change management and training, expert program management, and better business outcomes to increase the ROI of your technology investments.

You don’t have to choose between regulation and innovation. USDM Cloud Assurance is the managed platform that turns IT compliance into innovation. Download our datasheet to learn how the benefits of Cloud Assurance increase with your company’s cloud compliance maturity.

Download Our Whitepaper: Automate Validation Across Your Tech Stack

USDM spells out how Cloud Assurance harmonizes your GxP IT systems and delivers continuous compliance.

Computer Software Assurance

The FDA issued its draft of the Computer Software Assurance (CSA) Draft Guidance in September 2022. USDM has been studying, training, and implementing this risk-based CSA methodology for our customers for a few years. Cloud Assurance can be delivered for CSV or CSA, depending on your company’s GxP validation methodology. CSA is intended to enable modern cloud technologies, including automation, and make validation testing possible in a live production environment.

Watch this video on USDM’s approach >>>

Cloud Assurance for GxP Applications / Software-as-Service (SaaS)

Delivered for CSV or CSA, our SaaS onboarding and initial GxP validation include a defensible annual vendor audit for the U.S. Food and Drug Administration (FDA), 21 CFR Part 11 and EU Annex 11 Assessment, Validation Plan, URS/FSR, IQ/OQ/PQ Protocol and Test Scripts, Traceability Matrix, and Validation Summary Report.

Ongoing maintenance includes vendor release management, impact assessments, updated validation documents, test execution for core releases, analysis, and reporting for all cloud updates and patches.

USDM’s partnership network and technology solutions are designed to support your data-driven organization. We have solutions for eSignature, clinical trial management, content and document management, QMS, LMS, RIMS, supply chain, and many more, to establish the foundation for your IT compliance.

Cloud Assurance for Platform Services / Platform-as-Service (PaaS)

Companies like ServiceNow, Salesforce, Oracle, and Box trust USDM to ensure their technology is adopted effectively, powerfully, and in compliance. Delivered for CSA our PaaS onboarding and initial GxP validation includes a defensible annual vendor audit and a USDM Compliance Matrix (UCM) technical regulatory assessment for FDA Part 11 and EU Annex 11 Plan, Combined FSR/FRA, Test Protocols and Test Scripts, and Summary Report with Traceability Matrix.

Ongoing Maintenance includes vendor release management, release impact analysis and reporting, and updated Test Scripts for items impacting compliance with optional test execution.

Cloud Assurance for Cloud Environment / Infrastructure-as-a-Service (IaaS)

To reap the greatest benefits of the cloud, you need to think holistically about your tech stack. Getting your infrastructure to the cloud provides you with faster delivery, lower costs, and greater efficiency. Where you begin depends on where you are in your cloud journey. We use a flexible cloud adoption model to migrate regulated workloads to Google Cloud Platform (GCP), Microsoft Azure, or Amazon Web Services (AWS) based your IT and quality objectives for the various layers of your tech stack.

Private Cloud Use in Life Sciences

A private cloud is a cloud computing environment that is only used by one business or organization, with services and infrastructure hosted on a private network. A private cloud might be physically placed on-premises or hosted by third-party service providers. With a private cloud, you must maintain the hardware, software, and other supporting infrastructure.

Leveraging the Public Cloud in Life Sciences

Public clouds are owned and maintained by a cloud service provider such as Microsoft Azure, GCP, and AWS, that provides computing resources, like servers and storage via the internet. With a public cloud, the cloud provider owns and maintains the hardware, software, and other supporting infrastructure, while you control access and management of these services via a web browser.

Hybrid Clouds for Life Sciences

Hybrid clouds are a combination of public and private clouds connected by technology that enables you to share data and applications across them. By allowing data and applications to flow between private and public clouds, a hybrid cloud enables better flexibility and deployment choices for your organization, while also optimizing your existing infrastructure, security, and compliance.

Multi-Cloud Environments for Regulated Use

Multi-cloud combines the capabilities of many cloud providers, including private and public clouds. Although a multi-cloud strategy adds operational complexity, it provides flexibility by allowing users to select services from several cloud providers that are best suited for a particular activity or take advantage of services available in a certain region.

Cloud Assurance Certified

Now you see WHAT USDM can do; our Cloud Assurance Certified partners are HOW we can do it with system expertise and GxP-ready capabilities. Cloud Assurance Certified technology vendors meet the quality and compliance demands of the life sciences industry. Cloud Assurance Certified is a badge of trust for GxP functionality and a commitment to advance pharma, biotech, and medical device companies by making compliance a competitive advantage.

USDM’s Cloud Assurance Certification includes:

USDM’s Assurance Report, driven by USDM’s proprietary USDM Compliance Matrix, establishes the vendor’s credibility and compliance maturity and provides leverageable validation documentation.
USDM Resources and Assets required to enable technology to achieve life sciences GxP requirements with an FDA-approved Computer Software Assurance methodology.
USDM Cloud Assurance continuous compliance subscription to increase life sciences customer adoption.
Membership in USDM’s Cloud Compliance Advisory Board.

Read our blog – Cloud Assurance Certified: What Does It Mean? – to learn more.

Interested in becoming Cloud Assurance Certified? Fill out this form or email us at getcertified@usdm.com.

In Our Customer’s Words

“We have worked with USDM on several implementation projects including Box GxP, ComplianceQuest and most recently DocuSign GxP. The USDM team consistently approaches projects pragmatically, with a high degree of professionalism and enthusiasm. I particularly appreciate that they do not take a ‘one size fits all approach’ and work collaboratively with all of our stakeholders to ensure our business objectives are met. Further, the USDM Cloud Assurance service offering is a key enabler for us being a lean life sciences organization. We look forward to our continued partnership with USDM.”

– Executive Director, IS

“Our company had to dramatically and immediately change the way we work while still ensuring patient safety and compliance during this global pandemic. Our validation of 21 CFR Part 11 DocuSign was completed in an amazingly short amount of time with a high degree of quality by working with the USDM Cloud Assurance team. USDM’s Validation Accelerator Package for DocuSign, coupled with USDM’s experience and knowledge of how the life sciences industry has configured the tool, created a successful implementation.”

– Duane Mixon, Director, IT Service Delivery

“In preparation for, and support of, our first commercial launch, we worked very closely with USDM across various validation and Veeva initiatives. As an anchor, USDM provided us with a right-sized and repeatable software validation methodology that we have successfully used to rapidly establish and maintain compliance [Cloud Assurance] across our 10+ multi-tenant, GxP platforms. Most notably, USDM seamlessly partnered with our company and Veeva to deliver numerous Vault initiatives (QualityDocs, RIM, PromoMats, eTMF, CTMS, eQMS).”

– VP of IT and Facilities

We will happily provide references on request.

Assess Your State of Cloud GxP Compliance and Security with USDM’s Compliance Matrix

USDM has delivered thousands of GxP projects globally. As the trusted advisor to life sciences companies, we have created propriety tools to rapidly identify and remediate regulatory risk areas. Our USDM Compliance Matrix (UCM) is a comprehensive, global approach to assessing your regulatory and security maturity.

UCM is USDM’s automated tool to determine the global regulatory requirements, standards, and guidelines that govern your quality management practices. UCM provides the corresponding technical and procedural controls and assesses your organization’s GxP compliance to these business needs.

Shrinking IT budgets and growing business demands mean that you need a cost-effective, time-saving, managed service to achieve your business objectives. USDM Cloud Assurance combines cost savings and risk reduction to manage your technology and GxP compliance process from end to end, so you can focus on other priorities. We can handle one system or all your systems. We will take care of everything from hiring and managing the team, to achieving consistency of your policies across the enterprise, to delivering results.

Let us conduct a Lean IS Compliance Health Check to assess your state of regulatory compliance and IS efficiency, and provide a scalable plan to accelerate your IS maturity while handling your compliance workloads.

Learn more about Information Systems Health Checks here.

Real Results in Life Sciences with Cloud Assurance

Read our case studies to see measurable results.

USDM Cloud Assurance is your comprehensive, one-stop shop for IT compliance on a managed platform.

Not sure if Cloud Assurance is the right solution for you? Here are some of the customers we have helped:

Medical device company needing product data integrated into a modern Quality Management System (QMS) to create more efficient workflows
Pharmaceutical company needing clinical collaboration in a GxP compliant environment
Start-up company with no IT resources from the life sciences industry that required Computer Systems Validation (CSV) expertise
Biotech company needing to upgrade to a faster document management system (or enterprise content management system) to streamline collaboration through workflows and eSignature approvals
Pre-commercial company, needing a digital transformation strategy and IT roadmap to rationalize and consolidate applications, i.e., email, document management, file transfer protocol (FTP) servers and file share drives with a risk-based GxP compliance approach
Company planning or undergoing a change due to M&A activity and need guidance or helping hands to support your consolidation with standardization and harmonization

Don’t miss out on the latest technology trends that are shaping the life sciences industry in 2023. Read our new white paper here to learn strategies to stay ahead of the curve.

Ready to increase your team's capacity and innovate faster?

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