Domains

GMP Manufacturing Excellence

Elevate manufacturing efficiency and compliance with automation, technology optimization, and risk-based quality management

Transform your manufacturing operations with automation, technology optimization, and risk-based quality management expertise to achieve GMP operational excellence.

Manufacturing Compliance and Validation Across Systems

Ensure compliance with rigorous manufacturing standards by validating systems, processes, and equipment. Maintain audit readiness with comprehensive documentation and validation.

Supply Chain Integration and Traceability

Ensure quality, compliance, and product availability by integrating suppliers and maintaining traceability across all processes for seamless, efficient supply chain operations.

Technology Integration for Digital Manufacturing

Support real-time decision-making and automation by integrating MES, LIMS, QMS, ERP, and other digital tools, ensuring connected and efficient manufacturing processes.

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

Life Sciences Use Cases

Data Integrity and Quality Control

Ensure data integrity and product consistency with integrated quality systems, audit trails, and real-time monitoring across manufacturing workflows for compliance.
Read the case study >>>

Cybersecurity and Data Protection for Manufacturing Systems

Protect sensitive data and manufacturing systems with robust security, encryption, and vulnerability assessments to comply with regulations like GDPR and HIPAA. Learn more >>>

Product Serialization and Anti-Counterfeiting

Ensure product authenticity and compliance with serialization, inventory tracking, and anti-counterfeiting measures, supporting global supply chain security. Read the case study >>>

Post-Market Surveillance and Recalls

Use real-time monitoring and analytics tools to efficiently manage recalls, track product quality, and ensure compliance for ongoing safety and efficacy. Learn more >>>

Real-Time Monitoring and Process Control

Maintain control of manufacturing processes using IoT sensors and AI-driven monitoring to ensure quality, address deviations, and comply with standards. Read the case study >>>

Change Management and User Training for New Technologies

Adapt manufacturing workflows to new technologies with USDM’s change management and training, ensuring smooth adoption and digital readiness. Learn more >>>

Life Sciences Clinical Technologies

Manufacturing domain services to achieve operational excellence:

Save time and money with capabilities offered by USDM, which include:

Manufacturing System Validation: Ensuring that manufacturing systems, such as MES (Manufacturing Execution System), ERP, and automation tools, meet regulatory compliance standards, including FDA, EMA, GxP, and ISO requirements.
Data Integrity and Manufacturing Quality: Supporting the management and integrity of manufacturing data to ensure accuracy, traceability, and consistency throughout the production lifecycle.
Manufacturing Workflow Automation: Automating routine manufacturing workflows, such as batch record approvals, deviation management, and equipment calibration, to reduce manual effort, minimize errors, and accelerate production timelines.
Risk-Based Manufacturing Management: Implementing risk-based approaches to proactively address quality issues and deviations in manufacturing before they impact product compliance or safety.
System Integration and Interoperability: Integrating manufacturing systems with other enterprise tools, such as ERP, LIMS, and QMS, ensuring seamless data flow and collaboration between production and quality functions.
Cloud Assurance for Manufacturing Systems: Providing continuous compliance for cloud-based manufacturing systems with USDM’s Cloud Assurance, ensuring ongoing audit readiness and regulatory adherence.
Manufacturing Data Security: Implementing security protocols to protect manufacturing data, ensuring compliance with regulations like GDPR, HIPAA, and GxP standards.
Change Management and User Training: Managing change initiatives and providing training to support the effective adoption of new manufacturing systems, policies, and workflows.
GxP Compliant DevOps for Manufacturing Applications: Developing compliant DevOps frameworks for manufacturing applications to scale automation initiatives, ensure GxP adherence, and streamline system deployment.
Manufacturing Documentation Optimization: Supporting the implementation and optimization of manufacturing documentation systems, ensuring effective management and regulatory compliance of SOPs, batch records, and production logs.
Standard Operating Procedure (SOP) Development: Developing SOPs to ensure compliant and consistent manufacturing processes aligned with regulatory standards.
Vendor and System Evaluations, Selection, and Management: Evaluating, selecting, and managing manufacturing systems and vendors to ensure compliance, integration, and optimal performance.
System Design, Implementation, Validation, and Release Management for:
- Manufacturing Execution System (MES)
- Enterprise Resource Planning (ERP)
- Document Management System (DMS)
- Training Management System
- Deviation and Change Control Management
- Risk Management Platforms
- Supplier Quality Management System
- Secure Data Servers
- Electronic Batch Record (EBR)