When an audit or agency inspection identifies a GCP, GMP, GLP, GCLP, or Part 11/validation compliance issue, you must answer three important questions:
1. How significant is the finding?
2. How can you remedy current problems resulting from the noncompliance?
3. How can you prevent this noncompliance in the future?
Polaris experts can help you determine the root cause of a problem, and then implement a CAPA (corrective and preventive action) plan which answers all three of these questions. Polaris’ remediation and CAPA services can: