Tumont can assist with:

  • The production of all validation lifecycle documents, including plans, URS & design qualification reports; installation & operational protocols & reports; validation summary reports. We can provide complete document sets or “in-fills”.
  • Authoring administrative & compliance related policies, SOPs & procedural controls.
  • The review of suppliers’ validation documents for cGMP compliance.
  • Gap analysis & remediation.
  • Inventories
  • In-house training of staff new to the GMP environment.