Compliance Simplified

Cloud Assurance as a Platform Handles Automated Testing and Release Management

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2024 Trends in Life Sciences: Learn about 5 trends fueling the industry in 2024

Streamline management for all your GxP systems—including on-premises systems—and leverage automated testing for Software-as-a-Service (SaaS) releases.

USDM Cloud Assurance™ is an automated and compliant digital platform for GxP cloud-based technologies of any size or complexity. From a single cloud application to a multi-cloud environment, Cloud Assurance scales to the tech stack and IT infrastructure of your life sciences organization. It delivers a harmonized compliance framework that decreases your overall cost to manage compliance and increases operational efficiency.

Cloud Assurance as a Platform (CAaaP) is a service offering that automates the validation and testing of applications and software. It leverages USDM’s deep domain knowledge to validate, manage, and optimize GxP applications.

CAaaP seamlessly integrates with the validation lifecycle management (VLM) workflow in ProcessX. VLM can be used for initial implementation and enhancements, then a modified version is used for releases. It provides a single source of truth to manage everything associated with Application Lifecycle Management (ALM) and the implementation, upgrade, or enhancements of your GxP applications, including:

Change Control
Regulatory Applicability Assessments
Risk Assessments
Validation Deliverables and Artifacts
GxP System Inventory

Because you’re moving from manual testing to automated testing, you’re able to streamline validation, simplify release management activities, and eliminate deviations. USDM uses starting point scripts to implement automated testing, which saves you money compared to the typical cost of entry.

This end-to-end process becomes your single source of truth for compliance.

It’s time to reimagine your business workflows and achieve transformative outcomes for your business units.

With USDM’s Cloud Assurance as a Platform and ProcessX solutions, you’re able to:

Speed your time to market
Maintain a perpetual state of audit readiness
Lower your IT cost of ownership
Enable AI and machine learning tools in your processes
Harmonize your approach to digital quality

Unburden your teams of initial validation and ongoing compliance maintenance. CAaaP automated regression testing is hard at work ensuring that you remain continuously compliant.

More than 300 life sciences companies subscribe to the USDM Cloud Assurance managed service. They have confidence in best practices that are based on more than 23 years of life sciences GxP compliance experience.

We also work with best-in-class technology partners to develop solutions that meet the ever-evolving quality, compliance, and regulatory demands of the life sciences industry. USDM implements and maintains cloud software solutions that work harmoniously with your existing pharmaceutical, biotech, and medical device business applications. Or perhaps you want to consolidate and optimize your systems to decrease your IT footprint and spend. We’re here to help.

Download Our Whitepaper: Integrated GxP Compliance for the Life Sciences Industry

Discover a digital-forward approach to harmonize compliance and innovation.

Our GxP cloud systems expertise includes:

Building Management Systems
Clinical Systems (CDMS, CTMS, EDC, eTMF, ePRO, IRT)
Electronic Lab Notebook
Enterprise Content Management Systems
Enterprise Resource Planning (ERP)
Equipment Qualification
eSignatures and digital signatures for life sciences
Freezer Systems
Laboratory Systems (ELN, Freezer Management, LIMS)
Learning Management Systems (LMS)
Manufacturing Systems (ERP, PLM)
Quality Document Management Systems
Quality Management Systems (QMS)
Regulatory Publishing
Safety Systems and Signal Detection
Submissions
UDI & Serialization
and more

Computer Software Assurance

The U.S. Food and Drug Administration (FDA) issued the Computer Software Assurance for Production and Quality System Software draft guidance in September 2022. For several years, USDM has been implementing the risk-based Computer Software Assurance (CSA) methodology and training customers on it.

Cloud Assurance can be delivered for Computer System Validation (CSV) or CSA, depending on your company’s GxP validation preference. CSA is intended to enable modern cloud technologies—including automation—and to make validation testing possible in a live production environment.

Watch this video to understand how automated testing is used in production.

Cloud Assurance Certified

Now that you see what USDM can do, our Cloud Assurance Certified technology vendors are how we make it happen. System expertise and GxP-ready capabilities are helping to make compliance a competitive advantage. Cloud Assurance Certified is the badge of trust for GxP functionality and a commitment to advance pharma, biotech, and medical device companies. Our certified vendors meet the quality and compliance demands of the life sciences industry.

Features of the Cloud Assurance Certified program include:

Assurance Report driven by the proprietary USDM Compliance Matrix to establish the vendor’s credibility and compliance maturity. You’re also able to leverage the report as validation documentation.
USDM resources and assets that enable technology to meet GxP requirements and achieve validation using the CSA methodology.
Cloud Assurance continuous compliance subscription to increase customer adoption of technology.
Membership in the USDM Cloud Assurance Certified Advisory Board.

To learn more, read the blog Cloud Assurance Certified: What Does It Mean?

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

USDM Compliance Matrix

To determine what global regulatory requirements, standards, and guidelines govern your quality management practices, USDM created an automated proprietary tool called the Compliance Matrix. It provides corresponding technical and procedural controls and assesses your organization’s GxP compliance.

USDM has delivered thousands of GxP projects globally. Let us conduct an IS Compliance Health Check to assess your state of regulatory compliance and IS efficiency. You’ll come away with a scalable plan to accelerate your IS maturity and streamline compliance management workloads.

In Our Customers' 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.

Reliable Results with Cloud Assurance as a Platform

Growing business demands. Shrinking IT budgets.

What you need is a time saving, cost-effective managed service. USDM Cloud Assurance as a Platform manages your technology and GxP compliance processes from end to end so you can focus on other priorities. Whether it’s one system or all of your systems, we take care of hiring and managing the team, achieving consistency in your policies across the enterprise, and delivering results.

Read our case studies and explore the measurable outcomes:

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

Whatever it is you need for your life sciences organization, USDM has solutions. Learn more about our unmatched expertise in:

Or contact us to talk specifics.

Advances in technology—notably artificial intelligence (AI) and machine learning—help life sciences organizations use their vast amounts of data for valuable insights that propel them toward better patient care. Read the 2024 Trends in Life Sciences white paper to learn how.

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

Related Services

Cloud Managed Services

USDM’s managed services for life sciences are bundled into subscription models or offered at fixed fees to control your IT spending while maintaining compliance.

ProcessX

ProcessX is an intelligent, validated, GxP process automation platform that simplifies regulated workflows and processes to drive greater efficiency across your organization.

Artificial Intelligence

USDM has solutions for the GxP challenges you face when adopting automated solutions like machine learning, artificial intelligence, and automated testing.