Services

- Auditing clincial trials Phase I (CRO or clinical / horspital setting)

- Auditing clinical trials Phase II-IV

- Auditing GLP

- Auditing ISO 17025; in combination with GLP

- Remote auditing

- GxP training

- Quality Management System support / assessment / gap analysis

- Risk Management guidelines (NEN-EN-IEC 31000_2018)

- RIsk Management techniques (NEN-EN-IEC 31010)

- CAPA management

- Standard operation procedure (writing, review and overview)

- Preparation for inspection support

- Consultancy (GxP and Risk Management)

quality & risk management zw-frl   —   © Karin Baas 2022