Domains

Quality You Can Trust

Meet global Quality requirements for drug, biological, and medical device development and manufacturing practices.

Achieve consistent quality, regulatory compliance, and operational excellence by leveraging advanced technologies and automated GxP workflows.

Global Quality Compliance

Navigate the complex global quality landscape with tailored in-house or outsourced expertise to meet regulatory standards, ensure effective compliance, and adapt seamlessly to changing regulations, optimizing quality frameworks for life sciences organizations.

Data Integrity & Audit Readiness

Assess and enhance your quality management processes to streamline audit preparation, maintain data integrity, and ensure audit-readiness consistently, meeting rigorous regulatory requirements without compromising operational efficiency, while safeguarding data integrity.

Quality Process Automation & Efficiency

Develop innovative workflows that ensure compliance in your rapidly evolving digital environment. Leverage automation to optimize quality processes, reduce manual errors, boost efficiency, and maintain consistent compliance across the entire organization.

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

Quality Use Cases in Life Sciences

GxP Expertise

Scale your business and ensure FDA compliance with USDM’s GxP experts, including validation engineers and analysts for quality training and protocols. Read the case study.

Harmonized Quality Processes

Reduce compliance risks and meet inspection deadlines with USDM’s strategic QMS roadmap, SOPs, and cGMP training to address quality gaps. Read the case study.

Audits & Audit Readiness

Decrease audit time by 80% and save $112K annually with USDM’s Auditing-as-a-Service model, streamlining supplier audits and tracking. Read the case study.

Large-Volume Data Management

Meet EU MDR deadlines efficiently. USDM updated 450 QMS documents in four weeks, bringing together siloed divisions and delivering results on time. Read the case study.

Complicated Change Control

Transform to digital quality and complete validation testing in hours with USDM’s ProcessX, streamlining ITSM processes and approvals and adopting ServiceNow updates. Read the case study.

Deviation & CAPA Management

Reduce deviations, improve traceability, and save costs with ProcessX. Achieve digital transformation, reducing 67,200 hours of manual work annually. Read the case study.

Life Sciences Clinical Technologies

Life Sciences Quality Domain Capabilities

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

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