Package Name | Monthly Hours | Investment | Annual Savings |
---|---|---|---|
Core Compliance Support | 100 hours | $2,500 | Up to $6,000 annually |
Elite Compliance Assurance | 150 hours | $3,600 | Up to $10,800 annually |
Advanced Compliance Package | 200 hours | $4,600 | Up to $16,800 annually |
Premium Compliance Partnership | 300 hours | $5,700 | Up to $39,600 annually |
Activity | Hours Allocated | Description |
---|---|---|
Third-Party BRCGS Audit and Regulatory Readiness | 110 | Prepare documentation and records tailored for upcoming third-party or regulatory inspections, including FDA and BRCGS surveillance audits. Conduct mock audit sessions. |
Supplier Approval and Monitoring Program Review | 70 | Assess and verify supplier approval records, foreign supplier verifications, certificates of analysis, and supply chain risk assessments. Implement necessary updates or improvements. |
CAPA Management and Closure | 25 | Close outstanding corrective actions from internal, third-party, or regulatory audits, ensuring documentation of root causes and preventive measures. |
Procedure and Document Control Update | 35 | Review and revise key controlled documents, including supplier approval procedures, BRCGS compliance SOPs, and audit preparation procedures. Ensure document control compliance in FSMS software (if applicable). |
Remote FDA Inspection Support | 30 | Provide real-time remote audit support during audits (BRCGS, FDA, or customer audits), including on-demand document retrieval, record clarification, and immediate response preparation. |
Training Materials Update and Employee Training Records Verification | 30 | Assess training compliance specific to FSVP responsibilities, audit preparedness, and supplier qualification. Update training matrix and records accordingly. |
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