Discover a Digital-Forward Approach to Harmonize Compliance and Innovation
What is integrated GxP compliance? It’s a catalyst for innovation, adaptability, and continuous improvement while maintaining compliance of regulated cloud applications and on-premises IT systems. It’s not just a technological intervention, but a comprehensive life sciences ecosystem that thrives on outcomes.
What’s Inside This White Paper
- The inherent challenges of in-house validation versus the advantages of outsourcing to an outcome-based managed service model.
- The pivotal role of automation in maintaining compliance across a spectrum of validated Software-as-a-Service (SaaS) applications.
- How a single digital experience aggregates automated testing results, supporting documentation, compliance status, and critical event management for your cloud-based GxP systems.
- How a GxP process automation application fills the gaps in regulated business processes and delivers data-driven application lifecycle management.
- How Cloud Assurance, ProcessX, and the Cloud Assurance Dx dashboard combine into one integrated managed service.
Elevate GxP Management Through Unified Solutions
Embrace the integrated GxP compliance approach to achieve remarkable cost savings through innovative system development methodologies, progressive risk mitigation, and enhanced operational efficiency. It’ll help your organization to justify its investments, boost performance, and perpetuate continuous improvements while adhering to stringent regulatory requirements.
Empower your business with domain expertise related to:
- The inherent challenges of in-house validation and the significant advantages of outsourcing to an outcome-based managed service model.
- The pivotal role of automation in maintaining compliance across a spectrum of validated Software-as-a-Service (SaaS) applications.
- A single digital experience for your cloud-based GxP systems that aggregates information like automated testing results, supporting documentation, compliance status, and critical event management.
- A GxP process automation application that fills the gaps in your regulated business processes and delivers data-driven application lifecycle management.
Bridging the Gap Between Compliance and Innovation
USDM Cloud Assurance™ unburdens your organization of initial validation and ongoing compliance maintenance. ProcessX is a GxP process automation application that adapts to a wide range of business needs. The Cloud Assurance Digital Experience (Dx) dashboard gives you 24/7 access to notifications and documentation.
USDM’s Integrated GxP Compliance managed service unites Cloud Assurance for efficient and effective management of GxP systems; ProcessX for automated, extendable, and compliant GxP processes; and the Cloud Assurance Dx for a simple and trusted web application to help you achieve measurable results and see continuous improvement.
Integrated GxP compliance is more than a platform—it's a promise. A promise to accelerate your journey from molecule to market. Embrace the unified approach that reshapes your compliance journey, one outcome at a time.
The USDM Point of View
For life sciences organizations, compliance and innovation are too often treated as opposing forces — every new cloud application becomes another validation burden and another system to keep audit-ready. USDM’s view is that an integrated, outcome-based managed service breaks that trade-off. By combining automated validation, process automation, and a single digital experience, teams can keep regulated cloud and on-premises systems continuously compliant while freeing internal resources to focus on the science. Compliance becomes a continuous, default outcome rather than a recurring project — accelerating the journey from molecule to market. Explore the foundation in USDM Cloud Assurance and the broader role of data integrity in life sciences.
FAQ: Integrated GxP Compliance
What is integrated GxP compliance?
Integrated GxP compliance is a unified, digital-forward approach that maintains the compliance of regulated cloud applications and on-premises IT systems while serving as a catalyst for innovation, adaptability, and continuous improvement. Rather than a single technological intervention, it is a comprehensive life sciences ecosystem focused on outcomes.
What are the benefits of an outcome-based managed service model over in-house validation?
The white paper examines the inherent challenges of in-house validation and the advantages of outsourcing to an outcome-based managed service model — including cost savings through innovative system development methodologies, progressive risk mitigation, and enhanced operational efficiency that help justify investments and sustain continuous improvement.
How does automation support GxP compliance across SaaS applications?
Automation plays a pivotal role in maintaining compliance across a spectrum of validated Software-as-a-Service (SaaS) applications, aggregating automated testing results, supporting documentation, compliance status, and critical event management into a single digital experience for cloud-based GxP systems. See how this connects to computer software assurance (CSA) and 21 CFR Part 11 compliance.
What are Cloud Assurance, ProcessX, and the Cloud Assurance Dx?
USDM Cloud Assurance unburdens your organization of initial validation and ongoing compliance maintenance. ProcessX is a GxP process automation application that adapts to a wide range of business needs and fills gaps in regulated processes. The Cloud Assurance Digital Experience (Dx) dashboard provides 24/7 access to notifications and documentation. Together they form USDM’s Integrated GxP Compliance managed service.
How does integrated GxP compliance accelerate time to market?
By treating continuous improvement as a default outcome rather than a goal, integrated GxP compliance helps organizations keep regulated systems audit-ready while focusing internal resources on innovation — accelerating the journey from molecule to market, one outcome at a time.
Effective GxP compliance also depends on a strong control environment around your systems and partners — including life sciences cybersecurity and third-party risk management.
Contributors to Integrated GxP Compliance for the Life Sciences Industry:
- Kevin Brown, CEO and Co-Founder
- Vega Finucan, Co-Founder and Managing Partner
- John Petrakis, VP of Cloud Assurance
- Lisa Om, VP of Marketing
- Hovsep Kirikian, VP of Strategy and Operations
- Michelle Gardner, Senior Researcher and Writer
Bring Integrated GxP Compliance to Your Organization
See how USDM’s Integrated GxP Compliance managed service can harmonize compliance and innovation across your regulated systems. Contact us to talk through your GxP compliance goals.