What we do
Assessing your compliance today to create forward-thinking processes and efficiencies that defend against the regulatory complexities of tomorrow.
What if scientific discoveries were made safer and faster without the fear of an imminent audit from the FDA or international health authorities? Life sciences companies are challenged because the very core of their work is about human existence – improving and extending life itself. Regulators have massive civic responsibilities, but the government regulations slow the advancement of life sciences and medicine.
USDM’s Cloud Assurance is a managed service subscription delivering end-to-end GxP compliance including rapid implementation, validation, and maintenance to enable a continuously validated tech stack. USDM Cloud Assurance is THE digital platform for GxP cloud-based technologies of any size or complexity. Whether you have a single cloud application needing continuous validation or a multi-cloud system portfolio, Cloud Assurance will scale to meet your needs and deliver a harmonized framework that decreases your time and cost to maintain compliance.
USDM’s highly qualified auditors employ the U.S. Food and Drug Administration (FDA)’s Quality Systems Inspection Technique (QSIT) as their auditing approach to identify gaps in your system, process, and documentation.
Assessments take a more holistic approach to include recommendations for how to remediate and prioritize findings based on your unique circumstances, business priorities, resources, technical know-how, and regulatory knowledge.
USDM can manage your computer system, equipment, or process validation. From implementation to system use to ongoing vendor updates, we ensure your systems are compliant.
USDM helps regulated life sciences companies like yours make the best choices when selecting and integrating technology for GxP processes and applications across your organization. We excel at reducing implementation and validation time while optimizing your IT footprint and streamlining and automating your quality management processes.