Internal Audits
Often, internal audit programs suffer from auditors who are do not have the required expertise or are overloaded and don’t have the time to conduct effective audits. As a result, your internal audit program lacks credibility with audits that are superficial, ineffective and confrontational.
By partnering with USDM, we can provide experience, certified auditors who are knowledgable, flexible, objective and industry experienced. Our audit services can transform your audit program from superficial, ineffective and opinion-based to a management tool that is recognized by your organization in adding value by strengthening your work practices and processes, identifying opportunities for continued improvement, reducing areas of non-compliance and ensuring that your programs and procedures reflect current work practices.
Using the FDA QSIT approach, the USDM team can conduct internal audits on one or many aspects of your Production, Materials, Laboratory, Facilities, Equipment and Process Controls, CAPA and Quality Systems as well as ISO-13485, FDA, DEA, MHRA and GxP Regulatory audits. USDM audit services can help meet your internal audit schedules and provide audits that are to the proper depth, effective, objective, fact-based and non-confrontational.
Outsourcing your internal audits to USDM will add independence to your audit function allowing your employees to focus on essential business requirements, ensuring your quality system is in conformance, reducing your regulatory compliance exposure and saving you time and money.
Organizations often struggle with conducting objective management audits since the regulations require that an auditor cannot audit functional areas which they are responsible for. USDM can resolve the potential conflict of interests by providing an independent, objective management audit to assess the overall adequacy and effectiveness of your Quality Management System and Quality Unit.
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"
