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Audit
- QMS Audit: Quality audit is the process of systematic examination of a quality system carried out by an internal or external quality auditor or an audit team. It is an important part of an organization’s quality management system and is a key element in the ISO quality system standard, ISO 9001
- GAP Audit: A gap audit (also known as validation gap analysis) in the pharmaceutical industry looks at the difference between regulatory requirements affecting a company, and the practices and processes that a company currently uses.
- Vendor Audit: The main objectives for a vendor audit are to assess the quality management of the whole organization, through its procedures and data processes. We have a robust team for such audit to provide your company a means to verify that third party vendors meet the applicable FDA laws and regulations.
- Pre-inspection Mock Audit: Mock Audit is performed prior to regulatory audit by our experienced Quality auditors. The team assembles the requisite skill sets for the particular job and can handle the largest facility audit or the start-up who wants a quick review prior to the regulatory inspection.