Domains

Lab Digitalization and Change Management

Enhance laboratory management and continuous improvement to meet regulatory requirements and drive process improvements consistently.

Achieve breakthroughs faster by modernizing lab workflows and integrating systems for optimized performance and regulatory excellence.

Regulatory Compliance for GxP, 21 CFR Part 11, ISO Standards, and more

Adhere to regulatory standards for data integrity, ensure audit readiness, and maintain compliance across laboratory instruments, processes, and data management systems to meet GxP, 21 CFR Part 11, ISO standards, and other requirements.

Managing and Analyzing Large Volumes of Data for Insights

Extract actionable insights from massive amounts of laboratory data for research, quality control, and informed decision-making. Ensure data is managed efficiently, enabling laboratories to derive key insights that drive scientific innovation and support compliance.

End-to-End Validation and Compliance for New Laboratory Systems

Ensure that new laboratory systems meet regulatory requirements through comprehensive validation efforts, from planning and testing to full implementation. Guarantee that instruments, software, and data handling processes comply with GxP and other standards, supporting accuracy and quality in lab operations.

Unmatched Industry Expertise

Our deep experience in pharma/biotech, medical device, patient journeys, and digital technologies, including artificial intelligence and machine learning, help transform the R&D process, accelerate compliant device software development, and enhance patient experiences and outcomes.

Pharmaceuticals

Biologics & Biotechnology

Medical Device & SaMD

CRO/CMO

Other

Lab Use Cases in Life Sciences

Regulatory Compliance in Laboratory Documentation and Reporting

Automate documentation workflows, version control, and audit trails with platforms like Microsoft 365 and Veeva, ensuring traceable, compliant lab documents. Read the case study.

Laboratory Workflow Automation and Process Optimization

Automate manual lab workflows with RPA and AI to reduce errors and increase productivity, freeing up resources for more complex lab activities. Read the blog.

Data Integrity and Real-Time Monitoring

Maintain data integrity with automated validation, audit trail management, and real-time monitoring for compliance, supporting systems like LIMS and ELN. Learn more.

Efficient Sample Management and Tracking

Streamline sample tracking, labeling, and storage with automation tools and LIMS integration, reducing manual errors and ensuring sample integrity. Read the case study.

Secure Data Management and Cybersecurity

Protect lab data with encryption, secure storage, and compliance with GDPR/HIPAA. Continuous monitoring and role-based access controls safeguard against threats. Read the case study.

Laboratory Equipment Integration and Data Interoperability

Integrate lab systems to reduce redundancy, enhance data sharing, and ensure interoperability across LIMS, ELN, CDS, and other lab instruments. Learn more.

Life Sciences Clinical Technologies

Life Sciences Laboratory Domain Capabilities

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

Laboratory System Validation: Ensuring that lab systems, such as LIMS, ELN, and CDS, meet regulatory compliance standards, including GxP, 21 CFR Part 11, and ISO requirements.
Data Integrity and Quality Management: Supporting the management and integrity of laboratory data to ensure accuracy, traceability, and consistency throughout the testing lifecycle.
Laboratory Workflow Automation: Automating routine lab workflows, such as sample preparation and data entry, to reduce manual effort, minimize errors, and accelerate testing processes.
Risk-Based Monitoring and Quality Control: Implementing risk-based approaches to proactively address quality issues in laboratory operations, ensuring reliable results and regulatory compliance.
System Integration and Interoperability: Integrating laboratory systems with enterprise tools to ensure seamless data flow, interoperability, and enhanced cross-functional collaboration.
Cloud Assurance for Laboratory Systems: Providing continuous compliance for cloud-based laboratory systems with USDM’s Cloud Assurance, ensuring audit readiness and data integrity.
Laboratory Data Security: Implementing security protocols for laboratory data, ensuring protection and compliance with regulations such as GDPR, HIPAA, and GxP.
Change Management and User Training: Managing change initiatives and providing training to support effective adoption of new laboratory systems and workflows.
GxP Compliant DevOps for Laboratory Applications: Developing compliant DevOps frameworks for lab applications to scale AI initiatives, ensure GxP adherence, and streamline system development.
Laboratory Documentation Optimization: Supporting the implementation and optimization of documentation systems to enhance data management, record keeping, and regulatory compliance.
Standard Operating Procedure (SOP) Development: Developing SOPs to ensure compliant and consistent laboratory processes aligned with regulatory standards.
Vendor and System Evaluations, Selection, and Management: Evaluating, selecting, and managing laboratory systems and vendors to ensure compliance and optimal performance.
System Design, Implementation, Validation, and Release Management for:
- Laboratory Information Management System (LIMS)
- Electronic Laboratory Notebook (ELN)
- Chromatography Data System (CDS)
- Laboratory Sample Management System
- Data Integration Platforms
- Quality Management Systems (QMS)
- Automated Equipment Integration
- Lab Data Warehouse
- Secure Data Servers
- Environmental Monitoring Systems and more