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Remediation Assistance
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| When noncompliance with GCP, GMP or GLP requirements is identified in either an audit or an agency inspection, two questions still remain: 1) How significant is the finding? and 2) Can anything be done to remedy the situation? Polaris’ experienced personnel can assist in the response and implementation of corrective/preventive actions for observations identified through internal and external audits or FDA inspections of GCP, CGMP, and GLP activities. |
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| Polaris’ remediation services can: |
- Assist with timely and appropriate response to the agency or audit group, including determination of priority items and impact of the noncompliance on the company
- Recommend corrective and preventive actions to bring audit or inspection findings back into compliance and to maintain that compliance
- Review and, if needed, recommend revisions to:
- Quality Systems
- SOPs in all aspects of FDA compliance (GCP, GMP and GLP)
- Clinical auditing plans
- Site/CRO/Sponsor/IRB communication processes
- Supplier/vendor qualification and certification plans
- Evaluate the content and organization of Clinical Trial Master Files and recommend improved processes or systems similar to best industry practices
- 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
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200 Commonwealth Court, Suite 101 
