Validation des procédés, conseil, audit, consulting, formation

Process Validation

ADEQUAT EXPERTISE assists manufacturers in their efforts to control their manufacturing processes, whether special processes or conventional industrial processes. ADEQUAT EXPERTISE writes the protocols necessary for the validation of the process, in agreement with the applicable standards; He can also conduct the tests, qualify the laboratories, evaluate and summarize the results obtained. Once the process is validated, ADEQUAT EXPERTISE can intervene for the drafting of the associated procedures, the implementation of coherent workflows, the training of the personnel.

Areas of expertise

  • ISO13485
  • Animal tissue (ISO 22442 series)
  • Biocompatibility (ISO 10993 series)
  • Labeling and packaging (ISO 11607 series)
  • Sterilisation by radiation, ETO (ISO 11135 ET ISO 11137 series)
  • Clean room (14644 series)
  • Software validation (ISO 62304 – FDA 21CFR Part 11)


  • Writing or review of protocol for qualificationRisk assessment of manufacturing process
  •  Process diagnostic
  • Qualification audit for equipment
  • Subcontractor audit
  • Implementation of a management system for process validation
  • Training

For more information