Training Records & Documentation Compliance Program
Training Documentation & Subpart F Records Compliance Program Ensuring Recordkeeping Compliance under 21 CFR §117.9 and Subpart F
To assist food facilities in meeting FDA requirements for establishing and maintaining accurate training records, as required by 21 CFR §117.9 and §117.4(b)(2), in alignment with the full documentation standards under Subpart F. This program ensures facilities are prepared for FDA inspections and audits with complete, organized, and legally compliant records.
Scope of Work
Initial Program Setup (One-Time Fee):
✔ Training Records System Setup
- • Develop customized templates for employee training logs, sign-in sheets, certificates, and verification forms
- • Establish role-based training record matrices (including product-specific modules)
- • Align documentation practices with Subpart F standards (e.g., legibility, accessibility, review, and retention)
✔ Document Control SOP Creation
- • Define procedures for creating, modifying, reviewing, and archiving training records
- • Establish responsible personnel and approval workflows
✔ Historical Record Reconciliation
- • Review and format existing training records for compliance and audit-readiness
- • Identify missing or incomplete documentation and implement corrective actions
✔ Compliance Training on Documentation Standards
- • Educate staff on proper completion and handling of training records
- • Supervisor-specific briefing on recordkeeping responsibilities
✔ Digital & Physical Recordkeeping Infrastructure Recommendations
- • Option to integrate into electronic document management systems (EDMS) or binders
- • Recommend tools for secure storage and quick retrieval during inspections
Deliverables
• Training Record Templates & Custom Matrix
• Subpart F-Compliant SOPs for Documentation
• Documented Employee Training Logs & Certificates
• Audit-Ready Physical or Digital Binder Setup
• Monthly File Compliance Check Reports
• Annual Summary & System Integrity Audit
• Certificate of Recordkeeping Compliance Implementation
Fees and Subscriptions
Ongoing Monthly Maintenance Services:
- ✔ Monthly audit of new training records for Subpart F compliance
- ✔ Training re-verification logs and refresher reminders
- ✔ Updates to SOPs and documentation templates
- ✔ Quarterly records summary reports
- ✔ Remote support during regulatory audits
- ✔ Maintenance of multi-category training logs
- ✔ Annual recordkeeping system review and file integrity audit
Pricing Structure:
| Service Tier | One-Time Setup Fee | Monthly Maintenance Fee | Coverage |
|---|---|---|---|
| Standard | $1,200 | $650/month | Training records for up to 20 staff, 1 food category |
| Enhanced | $2,500 | $1,300/month | 20–40 staff, up to 2 food categories, file review |
| Premium | $3,800 | $1,950/month | 40–60 staff, 3+ food categories, full Subpart F audit support |
| Enterprise | Custom Quote | Custom Quote | 60+ staff, multi-facility, EDMS integration, digital archiving support |
• Add-On: Migration of historical training records – $350 per 100 records
• Add-On: Digital Binder Setup or EDMS Integration – Starting at $1,200 (one-time)
Ideal For:
- • FDA-regulated food facilities preparing for inspection
- • Organizations building or updating training documentation systems
- • Companies expanding production into new food categories
- • Facilities converting to digital recordkeeping or formal SOP frameworks
- • Co-packers and brand owners required to show documented employee qualifications