Quality Systems & Auditing

Audits of GxP and Quality Systems, API, suppliers, facilities, equipment, laboratories, processes

  • Auditors certified by IRCA (International Register for Certified Auditors) and ASQ (American Society for Quality)

Design, implementation and improvement of Quality System according to the applicable standards and guidelines (ISO9001, ISO13485, ISO22716, GxP)

  • Assessment of compliance
  • Implementation and improvement of CAPA system
  • Internal Audits and assistance to third part audits
  • Preparation/review of SOPs, Quality Manual, CAPA…

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