Domains
Life Sciences 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.
Ensuring Quality in Life Science Products
USDM supports life sciences manufacturing by ensuring compliance, data integrity, and validated systems across the lifecycle. From pharmaceutical manufacturing to medical devices, we help life sciences manufacturers implement MES solutions, streamline system integration, and adopt GMP automation—all backed by expert knowledge in technology and life sciences.
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.
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.
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.
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.
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 Advanced Technologies
Manufacturing services to achieve operational excellence:
Manufacturing Compliance & Process Excellence
Compliance-Driven Services to Keep Life Sciences Manufacturers Inspection-Ready
- Manufacturing System Validation: Validate MES, ERP, and automation systems to meet FDA, EMA, ISO, and GxP standards.
- Data Integrity and Manufacturing Quality: Ensure data accuracy, traceability, and consistency across the manufacturing lifecycle.
- Risk-Based Manufacturing Management: Apply proactive, risk-based strategies to prevent quality deviations and regulatory issues.
- Manufacturing Documentation Optimization: Streamline batch records, SOPs, and logs to ensure compliant, accessible, and audit-ready documentation.
- Standard Operating Procedure (SOP) Development: Develop and optimize SOPs aligned with regulatory expectations and industry best practices.
- Manufacturing Data Security: Implement robust security frameworks to protect regulated data and meet GDPR, HIPAA, and GxP compliance.
- Change Management and User Training: Drive adoption of new systems through structured change management and training programs for operational success.
- Vendor and System Evaluations, Selection, and Management: Select and manage vendors with a compliance-first approach to optimize system performance and integration.
Technology-Led Solutions to Modernize Life Sciences Manufacturing
- System Integration and Interoperability: Connect MES, QMS, ERP, and LIMS with tailored system integration solutions that enable end-to-end data visibility across manufacturing and quality operations.
- Manufacturing Workflow Automation: Automate critical workflows like deviation management, batch approvals, and calibration tracking to reduce errors and speed production.
- Cloud Assurance for Manufacturing Systems: Ensure continuous GxP compliance and audit readiness with USDM’s Cloud Assurance program for cloud-hosted manufacturing platforms.
- GxP-Compliant DevOps for Manufacturing Applications: Build and deploy systems faster with DevOps frameworks built specifically for GxP-regulated environments.
- System Design, Implementation, Validation, and Release Management:
- MES Solutions
- Enterprise Resource Planning (ERP)
- Document Management Systems (DMS)
- Deviation and Change Control Systems
- Training Management Systems
- Risk Management Platforms
- Supplier Quality Management Systems
- Secure Data Servers
- Electronic Batch Record (EBR)
Manufacturing execution system integrations and more
USDM empowers life sciences manufacturing with seamless manufacturing execution system in life science integrations, enhancing visibility, traceability, and compliance. Our experts deliver scalable system integration solutions, enabling life sciences manufacturers to optimize operations, adopt advanced technologies, and maintain quality across pharmaceutical manufacturing, medical devices, and global supply chain management.
More FAQs for Life Science Manufacturers
MES integration in life sciences manufacturing ensures real-time data, traceability, and control, helping life sciences manufacturers maintain product quality, ensure pharmaceutical manufacturing compliance, and support efficient GMP automation processes.
Cloud-based systems in life sciences manufacturing enable real-time monitoring, automated updates, and scalable GMP automation, helping life sciences manufacturers maintain continuous compliance across pharmaceutical manufacturing, medical devices, and global supply chain management.
The best way to manage supplier quality in life sciences manufacturing is through integrated MES solutions and system integration tools that ensure visibility, compliance, and control across the supply chain management process.
In life sciences manufacturing, automation enhances deviation and change control by reducing manual errors, enforcing GMP automation protocols, and streamlining workflows. Life sciences manufacturers gain speed, accuracy, and compliance across pharmaceutical manufacturing, MES solutions, and broader technology and life sciences ecosystems.
When validating new technologies in life sciences manufacturing, companies should ensure GMP automation compliance, data integrity, and compatibility with existing MES solutions. Life sciences manufacturers must also prioritize system integration, regulatory alignment, and scalability across pharmaceutical manufacturing and life science tech environments.
GxP-compliant DevOps accelerates system updates in life sciences manufacturing by combining automation with regulatory controls. Life sciences manufacturers benefit from faster, safer deployments across MES solutions, pharmaceutical manufacturing, and life science tech—while maintaining compliance, data integrity, and efficiency throughout the technology and life sciences ecosystem.
Achieve compliance, enhance efficiency, and bring high-quality products to market faster with USDM.
