Trust and Compliance

Data Integrity & Transparency in Life Sciences

Ensure compliance, reduce risk, and enhance data quality to confidently meet regulatory standards.

Ensuring trustworthy data, continuous compliance, and confidence across the product lifecycle

USDM’s Data Integrity & Transparency solutions help life sciences organizations safeguard critical information and ensure data remains accurate, consistent, and accessible throughout its lifecycle. Our frameworks embed compliance-by-design principles aligned with FDA, EMA, HIPAA, and other global standards, while leveraging automation, metadata management, and audit-ready reporting to eliminate risk. By enabling real-time visibility into data provenance, ownership, and traceability, USDM empowers organizations to make confident, evidence-based decisions, accelerate regulatory submissions, and unlock AI and advanced analytics with integrity-first assurance. The result is a resilient, compliant data foundation that supports innovation, operational excellence, and patient safety.

Build a Data Integrity Program for Compliance and Operational Excellence

Establish a comprehensive data integrity program that supports compliance, mitigates risk, and enhances data quality. Our structured approach includes thorough processes, SOPs, and customized checklists that make it easier to assess and detect areas of risk and find a resolution. We design a governance structure, define a compliance strategy, and provide tailored training programs that align seamlessly with your company’s unique priorities and regulatory requirements.

Optimize Data Governance and Integrity for AI-Driven Processes

Make certain your data is reliable and accessible, facilitates transparency and accountability, and is managed according to regulatory standards. USDM establishes strong data governance frameworks that ensure data integrity, consistency, and quality. This includes Master Data Management (MDM) and metadata management to create a unified and transparent data environment. We also build a robust governance structure for AI initiatives to help you achieve compliance, transparency, and alignment with regulatory requirements and support responsible and optimized AI-driven processes.

Automate Audit Trails and FDA Compliance

Achieve FDA compliance by implementing automated compliance and workflow programs that capture detailed logs of data access, modifications, and transfers. We integrate data systems like ERP, QMS, and document management platforms to create a unified and transparent data environment and make it easier for your organization to maintain compliance and accountability.

Improve UDI Data Integrity with a Single Source of Truth

Learn how we helped a global biotech and pharma manufacturer establish a scalable, single-source-of-truth data model to manage billions of product data points across more than 60 systems and support rapid growth and compliance. This solution decommissioned redundant systems, saved $500k annually, and enabled efficient data handling to meet regulatory and customer demands.

Domain Expertise

Success Stories

The GxP and GDPR-compliant platform built by USDM transformed a biotechnology company’s data management practices. The results:

Manual efforts reduced by 30%

1 %

Accelerated data access and analysis by 50%

1 %

Accelerated data access and analysis by 50%

$ 1 K

Resources that might interest you

Webinars

EU MDR Date of Application Readiness

Explore strategies for EU MDR compliance. Learn near-term and long-term steps, EUDAMED requirements, and key deadlines in our on-demand webinar and guide.

Blogs

AI, Adversarial Attacks, and Insider Threats in Life Sciences

With the integration of AI comes significant security risks. Learn how to overcome attacks and threats, starting with an AI risk assessment.

Case Studies

Enhancing Data Integrity and Accessibility for Antibody Medicine Development with AWS Data Lake

AWS Data Lake enabled GxP compliance, cut costs by 25%, improved data access by 50%, and delivered consistent insights for cancer antibody development.