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.
- In-house training of staff new to the GMP environment.