The Quality System is part of the Pharmacovigilance System and consists of its own structures and processes for

• Managing quality, regulatory and information security at the organization level
• Providing quality compliance services and ensuring compliance with applicable guidelines and legislations of the USFDA, EU, MHLW, ICH-GCP, 21 CFR Part 11, PIC/S, GAMP 5, HIPAA, CSV standards, data transfer content standards, ISO 27001, and 9001 Standards
• Record Deviations, CAPA Management Plans CAPA and performs RCA.