Records Compliance Management Program
Aligned with 21 CFR Part 117 Subpart F — Requirements Applying to Records
To ensure compliance with Subpart F of 21 CFR 117, this service helps regulated facilities establish, manage, and maintain required food safety records in an audit-ready format. The program ensures alignment with FDA’s recordkeeping requirements, including food safety plans, monitoring logs, verification records, and retention protocols.
Deliverables
1. Recordkeeping Structure Development
- • Design of compliant templates for all records required under 21 CFR 117 (e.g., food safety plan, monitoring logs, corrective actions, verifications)
- • Creation of a records matrix aligning documentation types with regulatory sections
2. Food Safety Plan Documentation Requirements
- • Guidance and tracking for required signatures under §117.310 (initial completion and modifications)
- • Record control checklist to confirm completeness and signature traceability
3. Retention Policy Setup
- • Schedule and procedures aligned with §117.315 for 2-year minimum retention periods
- • Special handling of validation studies and discontinued processes per §117.315(b)
- • Digital backup and retrieval strategy compliant with on-site access rules (24-hour window)
4. Electronic Record System Integration
- • Guidance for establishing compliant electronic record systems under §117.305(g)
- • Mapping of records to FDA Part 11 requirements where applicable
5. Written Assurance Support
- • Preparation of legally compliant written assurances per §117.335
- • Templates include effective date, signatures, acknowledgments of legal responsibility, and provisions for termination
6. Records Review & Gap Closure
- • Audit checklist to assess if records contain values/observations as required under §117.305(b)
- • Support for supplementing or reorganizing existing records under §117.330
7. Official Review Readiness
- • Binder/drive setup for physical or electronic record retrieval
- • Procedures to support §117.320 prompt availability for FDA inspections
Fees and Subscriptions
Service Fee Structure
| Package | Description | One-Time Set-Up | Monthly Maintenance |
|---|---|---|---|
| Standard | Up to 10 record types (basic monitoring & verification logs) | $1,250 | $750/month |
| Professional | Up to 25 record types, includes full food safety plan, validation, and assurance logs | $2,200 | $1,100/month |
| Enterprise | Custom package for complex operations or multi-facility programs | Custom Quote | Custom Quote |
All plans include document templates, tracking dashboards, monthly review assistance, and compliance alerts.
Ideal For:
- • Food manufacturers and processors preparing for FDA inspections
- • Facilities transitioning from paper to electronic records
- • Importers and co-packers who must coordinate compliance documentation with external suppliers
- • Operations with complex written assurance requirements or multi-tier supplier networks