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. Mock Pre-Approval Inspection Audits (PAI).Supplier Qualification Audits (CMO, CRO, API, Supply Chain, Distributor, Laboratory, Testing Services.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. We then verify that processes are documented and being followed, and that GxP records, objective evidence, and data integrity are adequate. We identify observations and gaps in systems, processes, and documentation. Our regulatory audits focus on investigating specific systems and processes to ensure they meet regulatory requirements and industry standards. 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 team of highly qualified auditors employs the U.S. USDM Life Sciences has been conducting audits and assessments for the biotech, medical device, and pharmaceutical industries for more than 20 years. Navigating global regulatory requirements is complicated.
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