Quality assurance

An independent Quality Assurance team is dedicated to the coordination of implementation and maintenance of IDDI’s Quality Management System (QMS).  It is at the forefront of the development and review of Standard Operating Procedures (SOPs) and ensures that study-related activities are performed in compliance with the Good Clinical Practice (GCP), protocol, contract, valid SOPs, applicable regulatory requirements and industry standards.

The Quality Assurance team is responsible for the following activities:

  • QMS auditing
    • Internal auditsQuality Assurance
    • Supplier audits
  • Sponsor audits and Regulatory Agency inspections
  • Management of nonconformities
  • Continuous improvement processes
    • Corrective and Preventive Actions (CAPA) tracking system
    • Quality indicators monitoring
  • Development and periodic review of SOPs
  • QA SOP training and general GCP training
  • Computerized System Validation (CSV)
  • Information Security