Consulting
GxP Managed Services
Proactive Support for Compliance, Efficiency, and Innovation
At USDM Life Sciences, our Managed Services model offers continuous, tailored support to maintain compliance, optimize operations, and enable seamless digital transformation. Unlike traditional consulting or staffing models, our managed services provide ongoing, proactive solutions designed to ensure uninterrupted performance in highly regulated environments.
What Sets Our GxP Validation Apart?
Continuous Compliance and Monitoring
Our Managed Services model delivers end-to-end support to ensure your organization stays audit-ready and compliant with global regulations. From cloud environments to quality systems, we continuously monitor and validate your systems, reducing risks and allowing you to focus on core business objectives.
Scalable and Flexible Solutions
With managed services, you can access a dedicated team of experts who scale services according to your organization’s evolving needs. Whether it’s ongoing validation, lifecycle management, or proactive risk monitoring, we adapt to meet operational demands without needing internal resource allocation.
Predictable Costs and ROI
By choosing managed services, you avoid the unpredictable costs of ad hoc consulting or the overhead of in-house teams. Our subscription-based or project-aligned offerings provide transparency and measurable ROI, enabling smarter resource management.
Benefits of Managed GxP Systems
Continuous GxP Compliance
Our experts ensure your systems, workflows, and data management processes comply with evolving global standards, including FDA, EMA, GxP, and ISO regulations. We maintain audit readiness through tools like Cloud Assurance while reducing manual effort.
Risk Mitigation and Data Integrity
Proactively protect your organization from compliance risks with real-time monitoring and robust data governance frameworks. Our solutions enable secure data pipelines, automated testing, and lifecycle validation, reducing errors and safeguarding your operations.
Operational Optimization
Our managed services extend beyond compliance to enhance your business operations. We streamline workflows, enable advanced automation, and integrate cutting-edge technologies like AI and machine learning, driving efficiencies across all domains.
Ongoing Technology Enablement
Stay ahead of the curve with expert support for new technologies. From validating cloud platforms to implementing AI-powered tools, we ensure your systems remain cutting-edge and aligned with your long-term business goals.
Key Features of USDM's GxP Services
Lifecycle Validation Management
Automate and manage the full lifecycle of system validations, focusing on GxP compliance. Our continuous validation solutions ensure seamless upgrades, efficient audit readiness, and reduced downtime.
Automated Workflow Optimization
Streamline quality, manufacturing, and regulatory workflows with advanced tools like ProcessX. Our managed automation solutions reduce manual tasks, minimize errors, and improve process efficiency.
Real-Time Monitoring and Reporting
Receive 24/7 system monitoring and actionable insights. Our proactive approach identifies and resolves potential issues before they impact operations, ensuring smooth and compliant processes.
Flexible Engagement Models
Whether you need ongoing support for specific systems or a fully outsourced compliance and technology management team, we offer customizable service packages to fit your unique needs.
By offering highly adaptable models alongside advanced capabilities across compliance, automation, data management, and digital transformation, USDM ensures that life sciences organizations can scale operations efficiently and drive significant business impact. Whether for targeted short-term initiatives or comprehensive long-term transformations, USDM’s talent solutions and managed services empower organizations to stay compliant, optimize processes, and remain competitive in a dynamic regulatory landscape.
Why Choose USDM's GxP Compliance Services?
Global Expertise: 900+ customers, including top-tier pharma and medical device companies, rely on our managed services to maintain compliance and operational excellence.
Proprietary Solutions: Cloud Assurance and other frameworks are specifically designed for life sciences to ensure seamless compliance in dynamic environments
Outcome-Driven Approach: Every service is tailored to deliver measurable improvements, from efficiency gains to cost savings.
FAQs About GxP Managed Services
How do GxP managed services help life science companies maintain regulatory compliance?
Systems that impact product quality, safety, and data integrity—such as LIMS, QMS, eTMF, ERP, and clinical platforms—typically require GxP validation services. USDM supports the validation and management of these critical GxP systems to ensure compliance, accuracy, and operational efficiency across regulated environments.
Ongoing support includes periodic review, change control, documentation updates, incident tracking, and revalidation when needed. USDM’s GxP managed services ensure your validated systems maintain compliance by offering proactive monitoring, scalable updates, and expert-led GxP consulting tailored to each platform’s risk profile.
USDM implements GxP-aligned controls, audit trails, and real-time monitoring to maintain data integrity and traceability across platforms. Our GxP services include validation, secure access controls, and lifecycle documentation—ensuring your data remains accurate, consistent, and defensible during audits or inspections.
Yes, USDM’s GxP managed services are designed to support hybrid and multi-cloud environments, ensuring compliant operations across AWS, Azure, Google Cloud, and private platforms. We provide validated GxP solutions that address the complexities of multi-cloud infrastructure while maintaining global quality compliance.
Partnering with USDM gives you access to industry-leading GxP validation services, compliance automation, and domain experts who specialize in GxP in life sciences. Our scalable GxP managed services reduce operational risk, ensure system performance, and support continuous improvement—making us a trusted long-term partner in regulated IT system management.
Let's discuss your GxP platform needs.
