Audit & Assessment Services

We offer various audit services: from preparing you for an upcoming audit or carrying out an audit on your behalf.  We help you to simplify and to well-organize the workflow and collaboration process to compile audits in order to be compliant with FDA, ISO, TüV Süd/Nord, QM and general audit process regulations.

Solution

• Internal & external GxP- and FDA readiness audits  

• Mock and customer audits

• Data Integrity audits

• CSV audits & Periodic Reviews

• FDA Pre-Approval Inspection preparation

• Conduct Quality audit  to ensure MDR compliance

• Act as ISO 13485, ISO 9001 auditor / audit preparation

• Act as GMP/ GDP auditor/ audit preparation

• IT supplier audit

Benefits

We ensure your organization is up to speed with all relevant regulations and guidelines required for your upcoming audit. We can provide you with an audit and action plan, perform gap assessments and support you through the entire audit process.