Monthly PCQI Oversight & End-to-End Compliance Support

Ongoing Food Safety & GMP Compliance Management

This program provides continuous, PCQI-led compliance oversight for food facilities requiring support beyond initial system setup, ensuring alignment with FDA requirements including CGMPs and Preventive Controls under the Food Safety Modernization Act (FSMA), while delivering a full-service solution that includes proactive compliance management, documentation control, training oversight, and audit readiness support to maintain compliance and reduce internal resource burden.

Program Objective

To provide continuous, structured compliance management and PCQI oversight that:
• Maintains audit-ready food safety and GMP systems
• Ensures ongoing alignment with FDA regulatory requirements
• Supports operational changes, new products, and process updates
• Reduces compliance risk through proactive monitoring and review
• Provides expert guidance without requiring a full in-house QA team

Scope of Work

A. GMP Program Oversight & Documentation Management

• Maintenance and continuous improvement of SOPs, forms, and compliance documents
• Updates based on operational changes, CAPA activities, and regulatory developments
• Document control management, including version tracking and issuance control
• Review of GMP records for completeness, consistency, and compliance

B. Training & Competency Management

• Ongoing refresher training and competency assessments
• Training matrix management and record updates
• Guidance on training delivery, documentation, and compliance tracking

C. Facility & Operational Monitoring Support

• Review of sanitation, pest control, and environmental monitoring records
• Verification of preventive maintenance and calibration systems
• Assessment of facility conditions, equipment layout, and storage practices
• Identification of operational risks and compliance gaps

D. Recordkeeping System Oversight

• Review of logs and records aligned with FDA Subpart F requirements
• Identification and correction of recordkeeping deficiencies
• Guidance on record retention, organization, and audit readiness
• Approval and control of new or revised documentation

E. FDA Inspection & Audit Preparedness

• Pre-audit document preparation and readiness reviews
• Remote support during FDA or third-party audits
• Corrective action development and root cause analysis support
• Assistance with non-conformance investigation and closure
• Liaison support during regulatory inspections

F. Regulatory & Compliance Advisory

• Ongoing monitoring of FDA regulatory updates and industry standards
• Compliance advisory support for operational or regulatory changes
• Periodic compliance reporting, including:
- ◦ Documentation status
- ◦ Recordkeeping performance
- ◦ Training compliance
- ◦ Continuous improvement recommendations

G. Client Communication & Reporting

• Routine compliance reports outlining system status and risks
• Scheduled virtual meetings to review progress and action items
• Ongoing collaboration to support continuous improvement initiatives

H. PCQI Oversight & Food Safety Plan Management

• Acting as the facility’s Preventive Controls Qualified Individual (PCQI)
• Development, implementation, and maintenance of the Food Safety Plan, including:
- ◦ Hazard analysis
- ◦ Preventive controls
- ◦ Monitoring and verification
- ◦ Corrective actions and reanalysis
• Oversight of supplier approval and verification programs
• Review and approval of product release and recall systems