Quality Audits

  • Quality audits in preparation for HPRA, FDA, EU, ISO 13485 and PS 9000 requirements and internal guidelines.
  • System specific GMP audits that focus on particular areas of  concern. These can form the basis of a quality improvement plan.
  • Pre-regulatory inspections and reviews that provide invaluable experience to site personnel in handling inspections effectively and efficiently.
  • Audit team training of key site personnel.
  • Audit follow up, including preparation of improvement plans.
  • Implementation of CAPA (Corrective & Preventive Action) systems.