Quality Assurance & Auditing
Let USDM's established Quality Assurance & Global Auditing practice provide life sciences industry experienced, certified auditors and quality professionals with hands-on operating experience assist you in assessing and ensuring the adequacy, effectiveness and current state of compliance of your GxP critical operations.
Auditor certifications include American Society for Quality (ASQ) Certified Quality Auditors (CQA), ASQ Certified Quality/Organizational Excellence Managers (CQM), Registrar Accreditation Board (RAB) and QSA International Quality Management Systems certifications and Software Engineering Institute (SEI) Capability Maturity Model Integrated (CMMI) certified appraisors.
USDM's specialized auditing and Quality Systems services include;
- Pre-Approval Inspection (PAI) audits to determine state of readiness and enhance probability of FDA approval.
- Internal Audits
- Vendor/Supplier Audits
- Management Audits
- Pre-Approval Inspection (PAI) Training
- Performance based Quality Systems audits for 21 CFR parts 58, 210, 211, 820, ISO-13485 and EMEA EU Guidelines including manufacturing, packaging, labeling and global distribution/logistics operations throughout the US, Latin America, EMEA, India and rest of world (ROW).
- Quality Management Systems including trending and correction of chronic/systemic issues, evaluation of effectiveness of corrective and preventive action (CAPA) systems and Quality Unit effectiveness
- Gap analysis audits of Computer systems development life cycle management and validation programs
- FDA QSIT-style systems audits of Production, Materials, Laboratory, Facilities, Equipment and Process Controls, CAPA and Quality Systems
- FDA, DEA and MHRA compliance and readiness audits
- Business Risk Management including risk assessments and associated follow on activities.
To learn more about USDM and how we can assist with your compliance and business objectives, please contact:
Rebecca Meledy
888.231.0816 x161
775.213.5943 (fax)
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"Simplify, Unify and Optimize your business & compliance needs with USDM"
