- Quality audits in preparation for HPRA, FDA, EU, ISO 13485 and PS 9000 requirements and internal guidelines.
- System specific GMP audits that focus on particular areas of concern. These can form the basis of a quality improvement plan.
- Pre-regulatory inspections and reviews that provide invaluable experience to site personnel in handling inspections effectively and efficiently.
- Audit team training of key site personnel.
- Audit follow up, including preparation of improvement plans.
- Implementation of CAPA (Corrective & Preventive Action) systems.