Third Party Audits

Third party audits (i.e. an FDA Audit) verify compliance to specific regulations or standards including FDA, State, OSHA, and EPA. It is conducted by an independent third party auditor which gives a fresh perspective from outside the organization and provides an objective assessment of a quality system. When referring to a third party audit as it applies to an international quality standard such as ISO 9000, the term "third party" is synonymous with a quality system registrar whose primary responsibility is to assess a quality system for conformance to that standard and issue a certificate of conformance (upon completion of a successful assessment). Third party auditors are more of advisors, showing companies what they need to change about their practices in order to perform at the highest levels. A third party audit of Quality Management Systems offers companies help in achieving continuous improvement in business performance and risk management, by registering the management systems as meeting the standards of a management system's third party accreditation standards. 

Requirements for Third Party Audits:

  • ISO9000:2008
  • ISO 19011:2002
  • AATB B1.520 On-Site Inspections
  • FDA 1271.400 Inspections (a) 

Sparta Systems Can Help You with Your Audit Challenges

Sparta Systems audit management solution assists the third party auditor to plan and execute audits more efficiently by providing an integrated tracking system and a powerful workflow engine that automates all steps in the audit lifecycle. It provides comprehensive tracking and trending capabilities that enable your company to demonstrate adherence to regulatory standards as well as your corporate policies. Dashboards provide standard reports to track the key critical-to-quality (CTQ) elements of your third party auditing programs on a recurring basis. For ad hoc reporting needs, it features a user-friendly query builder that can generate reports on any audit program criteria.  

  • Improve third party auditor efficiency by enabling them to document results and create offline observations which then automatically creates the records in the system when imported back
  • Facilitate compliance with global government regulations and industry standards 

An Effective Tool for Managing Any Type of Audit Including: 

  • Risk Assessment Audits
  • FDA/EMA
  • Security
  • Safety
     

Audit Management Solutions FAQs

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