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:

• 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 the 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
  • Training
  • Auditing plans
  • Validation plans
  • Site/CRO/Sponsor/IRB communication processes
  • Supplier/vendor qualification and certification plans
  • System documentation approaches or content
• Provide assistance to remediate paper and electronic records management and archival operations
• Interface with district FDA office regarding quality compliance issues

Compliance & quality consulting for your business success

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