Explore the advantages of automating workflows and testing for your regulated GxP systems.
In the ever-evolving life sciences industry, new technologies are helping startup companies and established global organizations redefine business workflows and achieve transformative outcomes. Additionally, the U.S. Food and Drug Administration (FDA) supports using automation—with the Computer Software Assurance (CSA) methodology in particular—to help life sciences companies bring drugs and medical devices to market faster and more efficiently.
To that end, USDM Cloud Assurance aims to deliver unparalleled regulatory compliance with automation built in. It starts by unburdening your organization of initial validation and ongoing compliance maintenance. Then, as your GxP tech stack grows, automated workflows and testing help to support your business goals. Cloud Assurance ensures end-to-end continuous compliance and increases the use and ROI of the GxP technology you already own.
See an illustration of transformational outcomes based on data from more than
300 USDM Cloud Assurance subscribers—get the Integrated GxP Compliance white paper.
Consider the Time and Cost Savings for Your Teams
Automated and ongoing software testing helps ensure that your regulated systems remain in a state of compliance—no matter how frequently vendors release updates, changes, and patches.
To simplify release management and enable your organization to perform consistent testing, Cloud Assurance automates testing activities for your cloud computing systems and supports full-suite regression testing. Automation also controls installation, configuration, and management, which translates to substantial time savings and effective cloud management practices.
For example, when using automation, there’s no need to wait for one process to finish before testing another; several processes can run concurrently and unattended. When cloud application vendors frequently release changes, ongoing automated testing helps ensure that regulated systems remain in a state of compliance.
Clarify the Complex with the Cloud Assurance Dx
Measuring, monitoring, and managing the compliant state of your cloud-based GxP systems requires maximum transparency and clear communication between you, your service partner, and technology vendors. That’s where the Cloud Assurance Digital Experience (Dx) web application comes in.
Using the Dx, you’re able to:
- Have 24/7 access to your dashboard whether you’re in the office, working remotely, or on the road.
- Get real-time compliance status in one dashboard for your managed applications or technology.
- Receive notifications and alerts (SMS, email, or other integrations) with action-specific messages in real-time wherever you are.
- Download from one place documents that support and defend validation and continuous compliance (i.e., vendor audits, release assessments, and validation-related artifacts).
- Access automated testing results, summaries, and schedules for regression testing for each supported application.
- Message the USDM team of experts within the context of the application.
- Request, track, and close change and enhancement requests for your applications.
- Access exclusive thought-leadership content applicable to technology and compliance.
- Engage in an online community of subject matter experts (SMEs) and industry peers to get your questions answered quickly.
Learn more about integrated GxP compliance and the Dx, an indispensable pair for continuous compliance through changes and releases—read the white paper.
Streamline Compliance Management Processes
If you’re still using spreadsheets and emails for your regulated GxP processes, then you’re putting your organization at risk.
Automate these processes and increase efficiency using ProcessX with Cloud Assurance. Together, they empower your digital teams to use automation to assess risk, enforce system policies, and document changes to the system.
Built-in automated compliance delivers quality by design. Regulations are no longer a barrier to innovation in your organization. You’re able to implement new workflows and gain valuable insight from your data to drive better business decisions.
The flexible ProcessX platform equips your teams to add and automate workflows using rule-based decision-making. It’s all done with clicks, not coding. Guesswork and human error are replaced by the ProcessX advantage.
“USDM’s Integrated GxP Compliance managed service unites Cloud Assurance for GxP system management; ProcessX for automated GxP processes; and the Dx web app to keep you updated on the status of your GxP systems.”
Discover the Value of GxP Domain Expertise
While most service partners provide automated testing, it takes GxP domain expertise to deliver strategic support for your testing efforts, mitigate risk, and maintain continuous compliance. USDM Life Sciences shares its comprehensive domain expertise and customizes innovative services that meet the current and future GxP compliance needs of more than 900 customers worldwide.
To ensure that your organization is making the best technology choices, our Cloud Assurance Certified program recognizes technology vendors that meet the quality and compliance demands of the life sciences industry.
As part of this program, USDM publishes its Vendor Assurance Report to prove the credibility and compliance maturity of its esteemed certified partners. To see the results of our rigorous assessment of these partners, download the report or contact us to request it.
Our consultants and SMEs are the best in their fields and customers rely on us to infuse greater efficiency in their processes and procedures. To guide your organization through digital transformation, our SMEs will help you integrate digital technologies and embed digital quality throughout your workflows.
Learn how advances in technologies like artificial intelligence (AI), the Internet of Things (IoT), and cloud computing can improve efficiency, effectiveness, and reliability in your organization—contact us today.