Navigating global regulatory requirements is complicated. We 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 FDA’s Quality Systems Inspection Technique 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 audit reports will unveil our findings based on years of unmatched industry expertise and create visibility to where you need to address potential risks.
- Software Vendor Qualification Audits
- Supplier Qualification Audits (CMO, CRO, API, Supply Chain, Distributor)
- Mock Audits
- GxP Audits (GCP, GLP, GMP)
- Pre-Approval Inspection Audits (PAI)
- Audit readiness
- Drug Accountability Audits
- Device Quality Audits
- Internal Audits
We provide single audit services, 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.
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. Additionally, we provide a recommendation for how you 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. And if you need us to do the remediation work too, we can help!
- EU MDR Assessment – The deadline of May 26, 2020, is approaching, and you need to be sure your Quality Management System is ready.
- IT Assessments – We inspect your IT infrastructure, processes, documentation, and roles and responsibilities of your IT team to ensure your technology and technical processes are compliant.
- Data Integrity Assessments – Your data is your most valuable IP. Your data must be correct, reproducible, and have controls in place to keep it that way.
- Quality Management Assessment – Your 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.
Quality System Upgrade to meet EU MDR / IVDR
MDSAP Ready in 4 Months
FDA Mandated Global CSV Remediation
Contact us now to get your questions answered by former FDA auditors at (888) 231-0816.
Or, you can email us your questions.