Quality assurance systems in clinical investigations

A quality assurance system (QSS) is critical for a company that assists in the design, planning, conduct, analysis and publication of reports and scientific articles to ensure compliance with regulatory requirements and to ensure the quality of clinical investigations of medical devices.

A robust quality assurance system is required by various international standards and laws. These include ISO 14155, the European Union's Medical Device Regulation (EU MDR 2017/745) and requirements of the European Medicines Agency (EMA), the Medical Device Law Implementation Act in Germany (MPDG) and the international ICH-GCP, which place specific requirements on quality assurance in clinical investigations. ISO/IEC 27001 (requirements for information security management systems), ISO 9001 (quality management systems), GDPR/DSGVO: General Data Protection Regulation, requirements of the EMA (EMA/INS/GCP/856758/2018 and EMA/INS/GCP/112288/2023) and, where applicable, the U.S. Food and Drug Administration (FDA, 21 CFR Part 11).

Elements of a quality assurance system include

• Clinical quality management: According to ISO 14155:2020, the sponsor must implement a comprehensive clinical quality management procedure, this can be delegated to a service provider.
• Risk management: A systematic approach to identifying, assessing and minimising risks is required, based on ISO 14971
• Standardised procedures (SOPs): Detailed instructions for all critical processes in the clinical investigation must be in place.
• Training system: Regular training for all staff to ensure compliance with GCP and regulatory requirements.
• Documentation system: A robust system for managing all study-related documents and data.
• Audits and inspections: Regular internal audits and readiness for external inspections are part of the quality assurance system.
• Information security management system: Implementation of suitable security mechanisms to protect sensitive data, with the objective of continuously improving integrity, availability, confidentiality and authenticity and taking appropriate measures to minimise and control risks.

Only a comprehensive quality assurance system that takes these elements into account makes it possible to conduct clinical investigations efficiently and in compliance with the law, while ensuring the highest standards of patient safety and data integrity.

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