Navigating global regulatory requirements is complicated. USDM can help.
USDM Life Sciences has been conducting audits and assessments for the biotech, medical device, and pharmaceutical industries for more than 20 years. Our team of highly qualified auditors employs the U.S. Food and Drug Administration (FDA)’s Quality Systems Inspection Technique in their auditing approach to ensure that your regulatory requirements are met, and you can demonstrate your Quality System is operating in a state of control.
Our regulatory audits focus on investigating specific systems and processes to ensure they meet regulatory requirements and industry standards. We identify observations and gaps in systems, processes, and documentation. We then verify that processes are documented and being followed, and that GxP records, objective evidence, and data integrity are adequate.
USDM knows that knowledge is security, so our audit reports outline our findings based on decades of industry experience and gaining visibility to potential compliance and security risks. USDM audit services include:
- Software Vendor Qualification Audits
- Supplier Qualification Audits (CMO, CRO, API, Supply Chain, Distributor, Laboratory, Testing Services
- Mock Audits (FDA, EU)
- GxP Audits (GCP, GLP, GMP, GPV, GRP)
- Mock Pre-Approval Inspection Audits (PAI)
- Audit readiness (Agency and ISO)
- Drug Accountability Audits
- Device Quality Audits
- Internal Audits
- Auditor Training
We provide single audit services and staffing augmentation to supplement your current audit team, or managed services, (i.e., Auditing-as-a-Service) where we provide a team of auditors to handle all your auditing needs. USDM can design an audit solution to meet your needs.
Our assessment services take a more holistic approach to your regulatory requirements. Just like audits, we uncover the gaps and risks to your systems and processes and deliver a report of our findings. During an assessment we may use a variety of techniques to gather pertinent information, based on the needs of your organization. We provide recommendations for how to remediate those findings and prioritize them based on your unique circumstances: your business priorities, your resources available, your technical know-how, and your understanding of the regulation.
USDM provides remediation services to assist in addressing the findings. See what the difference could be.
Compliance and Security Assessment Services
- EU MDR Assessment – EU MDR and IVDR regulations require a fundamental change in most regulated processes in a medical device company (i.e., product identification, EUDAMED submission, changes in relationships with economic operators, QMS changes, etc.). USDM’s EU MDR assessment addresses these items with a detailed orientation of the sequence of activities and prerequisites to meet the Dates of Application.
- IT Assessments – USDM assesses your IT infrastructure, processes, documentation, and the roles and responsibilities of your IT team to ensure your technology and technical processes are compliant.
- Data Integrity Assessments – Data is your most valuable intellectual property (IP). Data must be accurate and reproducible, with controls in place to keep it that way.
- Quality Management Assessment – The quality system is the heart of what enables your business to thrive, and you can’t afford to have gaps that jeopardize your compliant state.
- CSV Assessments – Computer System Validation assessments ensure your systems and applications are GxP compliant. We offer both on-prem and cloud CSV assessments. We can help you implement the FDA’s recommended Computer Software Assurance (CSA) approach.
Compliance Audit Case Studies
Get your questions answered by former FDA auditors.
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