Domains
Supply Chain in Life Sciences
Access real-time data for effective management and resilience in the complex life sciences supply chain.
Strengthen your supply chain resilience with compliance, automation, and real-time data integration expertise—ensuring quality, minimizing risks, and driving operational excellence.
Supply Chain Compliance Across Systems
Ensure compliance with rigorous supply chain standards by validating systems, processes, and equipment. Maintain audit readiness with proper documentation and continuous oversight to meet industry regulations.
End-to-End Supply Chain Traceability
Ensure quality, compliance, and product availability through seamless integration and traceability across suppliers. USDM enables visibility into every step of the supply chain to minimize disruptions and support regulatory adherence.
Supply Chain Optimization
Improve operational resilience and decision-making by leveraging AI and machine learning for AI-driven demand forecasting. USDM optimizes supply chain processes to enhance agility, minimize risks, and adapt to changing market needs.
Unmatched Industry Expertise
With unmatched industry expertise, USDM delivers tailored solutions that modernize compliance and technology, ensuring seamless regulatory adherence while optimizing processes and driving operational excellence. We empower life sciences companies to achieve their most ambitious goals, bringing transformative therapies to market and helping humans thrive.
Pharmaceuticals
Biologics & Biotechnology
Medical Device & SaMD
CRO/CMO
Other
Supply Chain Use Cases in Life Sciences
AI-Driven Demand Forecasting
Predict inventory needs starting with an AI Maturity Assessment and AI Infrastructure Development from USDM. Read the white paper.
Data Strategy and Integration
Maintain a single source of truth based on insights into supply chain performance to optimize inventory levels. Learn more.
Supplier Performance and Compliance Management
Manage vendor risks and monitor performance using USDM’s Regulatory Compliance Assessments. Learn more.
IoT Integration for Real-Time Data Tracking
Track materials from raw inputs to final product distribution using IoT solutions from USDM. Lean more.
Robotic Process Automation (RPA)
Automate repetitive rule-based tasks with RPA bots to enhance operational efficiency and reduce manual errors. Read the blog.
Change Management and User Training for New Technologies
Support technology adoption with USDM’s Change Management and User Training services. Learn more.
Life Sciences Clinical Technologies
Life Sciences Supply Chain Domain Capabilities
Save time and money with capabilities offered by USDM, which include:
- Supply Chain System Validation: Ensuring that supply chain systems like CTMS, EDC, and eTMF meet regulatory compliance standards, including FDA, EMA, and GCP requirements.
- Data Integrity and Quality Management: Supporting the management and integrity of supply chain data to ensure accuracy, traceability, and consistency throughout the lifecycle.
- Supply Chain Workflow Automation: Automating routine supply chain workflows to reduce manual effort, minimize errors, and accelerate supply chain timelines.
- Risk-Based Monitoring and Quality Management: Implementing risk-based monitoring approaches to proactively address quality issues before they impact the supply chain.
- System Integration and Interoperability: Integrating supply chain systems with enterprise tools, ensuring seamless data flow, interoperability, and cross-functional collaboration.
- Cloud Assurance for Supply Chain Systems: Providing continuous compliance for cloud-based supply chain systems with USDM’s Cloud Assurance to maintain audit readiness.
- Supply Chain Data Security: Implementing security protocols for supply chain data, ensuring protection and compliance with regulations like GDPR and IPAA.
- Change Management and User Training: Managing change initiatives and providing training to ensure effective adoption of new supply chain systems and workflows.
- GxP Compliant DevOps for Supply Chain Applications: Developing compliant DevOps frameworks for supply chain applications to scale AI initiatives, ensure GxP adherence, and streamline development.
- Electronic Trial Master File (eTMF) Optimization: Supporting the implementation and optimization of eTMF systems to enhance documentation management and ensure regulatory compliance.
- Standard Operating Procedure (SOP) Development: Developing SOPs to ensure compliant and consistent supply chain processes aligned with regulatory standards.
- Vendor and System Evaluations, Selection, and Management: Evaluating, selecting, and managing supply chain systems and vendors to ensure compliance and optimal performance.
- System Design, Implementation, Validation, and Release Management for:
- Electronic patient-reported outcomes (ePRO)
- Electronic document management system (EDMS)
- Electronic common technical document
- Interactive response technology (ITR)
- Interactive Voice Response System (IVRS)
- Electronic data capture (EDC)
- Electronic trial master file (eTMF)
- Supply chain data warehouse
- Secure data server
- Safety database and more