Make the audit useful
WinnPharma provides risk-based audits for GMP and GDP activities. The scope is agreed around the operation, the applicable requirements and the questions the audit needs to answer.
- Internal quality-system and operational audits
- Supplier and service-provider audits
- Document and evidence review
- Factual findings with a clear explanation of significance
Turn findings into meaningful action
The value of an audit continues after the report. Kyle can support the review of responses, challenge weak links between causes and actions, and help define appropriate follow-up.
- Audit preparation and scope development
- Findings discussion and report preparation
- CAPA response review and follow-up
- Evidence of implementation and effectiveness
Kyle’s CQI | IRCA registration is PQMS - GMP - Associate Auditor. Audit scope and the competence required for each engagement are agreed before work begins.
