an umbrella, quality reassurance page
  • Document management: development, implementation and maintenance of the Company IMS
  • Oversight: development and monitoring of the Company’s Quality Objectives and Key Performance Indicators (KPIs)
  • Qualification and on-going re-evaluation of external vendors
  • Processes and services: Implementation and maintenance of quality change management activities
  • Quality Risk Management: Continuous risk management review and adjustment
  • Issue Management: Response to quality issues with appropriate Corrective and Preventive Action (CAPA) plans
  • Training: Continuous training of employees and third parties including training in quality, GCP, information security and data protection
  • Regulatory support and knowledge management: support in the interpretation and consultation on regulations, guidelines, and standards ensuring and overseeing local regulation requirements compliance
  • Development of study specific quality plans and quality metrics
  • Auditing activities (on-site, TMF audit, process audit, etc.)
  • Inspection readiness activities
  • Oversight of clinical trials compliance with GCP, protocols, local and international legislation, Company and Sponsor SOPs, Policies and guidelines

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