CAPA and Remediation Assistance

1. How significant is the finding?
2. How can you remedy any current problems resulting from the noncompliance?
3. How can you prevent this noncompliance in the future?

Polaris experts can help you develop and implement a CAPA (corrective and preventive action) plan which answers all three of these questions.
 

• Assess impact of noncompliance on your company and prioritize response activity
• Recommend corrective and preventive actions that incorporate existing processes as much as possible and are appropriate for extent and severity of problem
• Assist with timely and appropriate response to the agency or audit group
• Review and, if needed, recommend revisions to:
  • Quality Systems
  • SOPs
  • Auditing plans
  • Site/CRO/Sponsor/IRB communication processes
  • Supplier/vendor qualification and certification plans
• Provide staff development and training to address both basic and specific observation-related needs
• Provide assistance to remediate records management and archival operations, including electronic records
• Interface with district FDA office regarding quality compliance issues