PCQI Oversight & Verification Records Maintenance
Compliance with 21 CFR §§ 117.180 & 117.190
This service ensures compliance with FDA requirements for preventive controls qualified individuals (PCQIs) and qualified auditors, while maintaining and verifying all implementation records associated with your food safety plan. We provide expert oversight, documentation, and audit preparedness support aligned with 21 CFR Part 117 Subparts C, F, and G.
Scope of Work
Core PCQI Oversight Inclusions
We create, organize, and maintain all required documentation under §117.190:
- • Hazard analyses and justifications for controls not established
- • Monitoring logs and trend analysis
- • Corrective action reports and response timelines
- • Validation studies and calibration logs
- • Product and environmental testing documentation
- • Supply-chain verification records
- • PCQI and auditor training documentation
- • Reanalysis justifications and audit trails
Monthly Maintenance Support Includes
- • Real-time document review and update tracking
- • Annual PCQI audit-readiness report
- • Quarterly training review and staff refresher session tracking
- • Ongoing monitoring of compliance documentation under Subparts C, F, and G
- • Secure digital recordkeeping aligned with FDA requirements
- • On-demand PCQI support for new hazard evaluation or supply chain event
Fees and Subscriptions
Service Fee Structure
| Plan | Description | Monthly Fee |
|---|---|---|
| Compliance Essentials | PCQI oversight, implementation records, training log management | $950/month |
| Audit-Ready Premium | Includes verification prep, auditor coordination, and mock FDA inspection support | $1,750/month |
| Multi-Facility Enterprise | Covers multiple sites, centralized record control, and annual audit program | Starts at $2,950/month |