Services > Quality Management/-Assurance

The quality assurance system of ACC Analytical Clinical Concepts has been implemented since 1997 and is continuously improved according to the actual GLP-, GCP-, GMP guidelines. All relevant processes concerning quality are described in SOPs and test instructions. These processes are monitored by the quality assurance program.

The quality management includes following activities.

  • Quality assurance program (planning, conducting and reporting of inspections)
  • Preparing of annual training schemes, training of personnel
  • Administration and archiving of SOPs
  • Evaluation of the requirements of new guidelines
  • Assisting sponsor audits
  • Assisting authority inspections and answering of authority requests
  • Suggestions for corrective actions, monitoring and documentation of implementation of corrective actions, risk-management

The quality assurance program mostly includes the following activities:

GLP
  • Project independent inspections according to the annual masterplan
  • Project dependent inspections of analytical protocol, analytical project performance and analytical report
  • Preparing of inspection reports and follow up of findings
  • Preparing of QAU-statement

GCP
  • System audits in clinic units
  • Study audits including study protocol, ICF, CRF and TMF
  • Study audits during clinical performance
  • Preparing of audit reports and follow up of findings
  • Preparing of QAU-statement

GMP
  • Planning, conducting and documentation of self inspections
  • Project dependent inspections
  • Involvement in OOS procedures