Quality Management System

TaRGeT's Quality management system covers both its fundamental research and customer service platforms' : the ViVeM center, the Gene Therapy Immunolog Core (GTI) and the Pre-clinical Analytical Core (PAC) activities.

Since 2006, this quality management system is approved by LRQA for its compliance with the requirements of the international standard ISO 9001 (Certificate_ISO9001_UMR1089).

It covers topics such as procedures and documentation management, data traceability, derogations and treatment of deviations, change controls, training of operators, facility and equipment management, quality controls systems, customer satisfaction, management of suppliers and subcontractors.

In addition to the requirements of ISO9001 standard, other recommendations and requirements specific to platform activities can be implemented (while not certified by external organisms), for example

  • GcLP standards, as part of clinical studies involving the laboratory
  • ICH recommendations when required
  • GLP applicable recommendations for pre-clinical in-vivo projects
  • GMP requirements as well as the ATMP guidelines when applicable, for translational manufacturing projects.

Among these additional requirements, our quality management team, among others, can independently audit your project's data, set-up the validation of bioanalytical methods, computerized systems and qualification of equipment, specifically train operators to the required guidelines.

Our Quality experts also provide counseling services to support quality management in health and biotechnology research laboratories:

  • Setting up a Quality Management System for ISO certification
  • Management of project quality
  • Validation Master Plan and related validation of bioanalytical method, computerized system and qualification of equipment
  • Quality management of suppliers and sub-contractors
  • Quality trainings
If you are interested in a quality counseling, please contact the head of quality team:
Héloïse Fonteneau, Heloise.fonteneau@univ-nantes.fr
Mis à jour le 03 April 2024.