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

FAQs About Data Integrity & Transparency in Life Sciences

What is data integrity in the context of life sciences, and why does it matter?

Data integrity means that data is accurate, complete, consistent, and trustworthy across its entire lifecycle. In regulated industries like life sciences, this is not optional—it’s foundational. USDM ensures data adheres to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, and more), meeting strict FDA, EMA, and global GxP expectations.

How does USDM help organizations ensure data integrity across systems and processes?

USDM delivers end-to-end data integrity frameworks that span cloud platforms, enterprise systems (ERP, MES, LIMS, QMS), and document management tools. We deploy:

Data audit trails
Role-based access controls
Continuous monitoring and alerting
SOP alignment and remediation
Our proprietary Cloud Assurance and lifecycle governance models ensure that integrity is built-in, not bolted on.

What is the connection between data integrity and transparency?

Transparency is about visibility into how, where, and why data is generated or changed. USDM enhances transparency by making data lineage, access logs, and system changes traceable and reportable—creating a single source of truth across regulatory, clinical, and manufacturing domains.

What kinds of risks do life sciences companies face if they don’t address data integrity?

Without proper controls, organizations risk:

Regulatory citations and warning letters
Product delays or rejections
Data manipulation or loss of credibility
Failed inspections
USDM helps organizations stay always audit-ready by embedding integrity into every data touchpoint—proactively, not reactively.

Can USDM assess the current state of our data integrity and provide a roadmap?

Absolutely. Our experts conduct Data Integrity Maturity Assessments to benchmark your environment, identify gaps, and recommend a prioritized remediation roadmap. This includes system audits, procedural analysis, access and change control reviews, and future-proofing with automation where possible.

What systems and platforms does USDM support for data integrity improvements?

USDM supports all major platforms used in life sciences, including:

Cloud (AWS, Azure, GCP)
LIMS, QMS, ERP, MES, eTMF
Content and document management systems
We ensure these platforms meet 21 CFR Part 11, Annex 11, and GAMP 5 standards for electronic records and signatures.

How does USDM’s approach help prepare organizations for AI and GenAI readiness?

AI only works when data is trustworthy. We prepare clients for GenAI and ML adoption by:

Harmonizing hybrid and multimodal data
Applying metadata tagging and classification
Ensuring governance policies are enforced across the data pipeline
This foundational integrity makes your organization AI-ready with confidence.

What measurable outcomes can we expect from implementing USDM’s data integrity solutions?

USDM drives transformative outcomes such as:

Reduced audit findings and regulatory risk
Streamlined inspections and reporting
Faster decision-making via trusted data
Improved cross-functional data visibility
Increased operational efficiency through automation.

Does USDM offer managed services for continuous data integrity compliance?

Yes. Our GxP Managed Services provide continuous oversight of data systems, validation lifecycle management, and compliance monitoring. We maintain data integrity over time—not just at a point-in-time—with 24/7 monitoring, automated alerts, and performance dashboards.

How do we get started with USDM’s Data Integrity & Transparency solutions?

Start with a compliance readiness discussion or data maturity assessment. From there, we tailor a roadmap that aligns with your current systems, compliance needs, and digital goals—delivered via consulting, managed services, or staff augmentation.

Let’s ensure your data is not just compliant—but a strategic asset.

Resources that might interest you

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.

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.

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.