Quality Management & Auditing

Quality Management

  • Interim quality management
  • Implementation of quality systems
  • Preparation and accompaniment of client and authority inspections (e.g.: FDA, local authorities)
  • System analysis and troubleshooting
  • Training system management
  • Handling of deviations, changes, corrections, and preventive measures
  • Drafting of standard operating procedures
  • Creation and implementation of concepts for supplier qualification and re-qualification

Auditing

  • Supplier audits in accordance with applicable guidelines (GMP, GLP, GDP, GCP, ISO standards) and requirements of the client
  • Internal audits in order to prepare for inspections by authorities
  • Routine internal audits
  • Audits of plasma donation centers
  • Audits in the light of recent events
  • Audits on documents and records
  • Due diligence audits

“Social skills and empathy have as great a role to play as experience and professional expertise in generating excellent results. Only by actively considering staff concerns and understanding their situation can solutions be found which are fully accepted and supported.”

Adolf König
Director Quality Management & Auditing

Your Questions?

If you have any questions regarding our services or wish personal consultation, do not hesitate to contact us.

T. +43-(0)1 79 80 334
E.