Records Compliance Management Program

Aligned with 21 CFR Part 117 Subpart F — FDA Recordkeeping Requirements

This program provides a complete system for establishing and maintaining FDA-compliant food safety records in accordance with 21 CFR Part 117 Subpart F, ensuring that all required records—including Food Safety Plans, monitoring logs, corrective actions, and verification records—are accurate, traceable, and audit-ready under the Food Safety Modernization Act (FSMA).

Program Objective

To develop and maintain a structured recordkeeping compliance system that:

• Meets all FDA Subpart F documentation requirements
• Ensures records are complete, accurate, and properly reviewed
• Establishes retention, accessibility, and traceability controls
• Supports FDA inspection readiness and audit defensibility
• Enables transition to compliant digital recordkeeping systems

Deliverables

1. Recordkeeping Structure Development

• Design of compliant templates for required records, including:
- ◦ Food Safety Plan documentation
- ◦ Monitoring logs
- ◦ Corrective action records
- ◦ Verification and validation records
• Creation of a records matrix linking documentation to regulatory requirements

2. Food Safety Plan Documentation Controls

• Guidance on required signatures and approvals under 21 CFR §117.310
• Record control checklist ensuring completeness and traceability
• Procedures for managing document revisions and approvals

3. Record Retention & Storage System

• Development of retention policies aligned with 21 CFR §117.315
• Minimum two-year retention framework with extended requirements for specific records
• Handling of validation studies and discontinued processes
• Digital backup and retrieval strategies supporting FDA access requirements

4. Electronic Record System Integration

• Guidance for implementing electronic records in compliance with 21 CFR §117.305
• Alignment with FDA electronic record expectations (including Part 11 where applicable)
• Mapping of digital workflows to regulatory requirements

5. Written Assurance Documentation

• Preparation of compliant written assurances under 21 CFR §117.335
• Templates including:
- ◦ Effective dates and signatures
- ◦ Legal responsibility acknowledgments
- ◦ Terms for maintenance and termination

6. Records Review & Gap Closure

• Audit checklist to verify records include required observations and values
• Identification and correction of documentation gaps
• Support for reorganizing or supplementing records to meet compliance expectations

7. Inspection & Audit Readiness

• Organization of physical or electronic record systems for rapid retrieval
• Procedures to ensure prompt availability of records during FDA inspections
• Structured filing systems aligned with regulatory expectations

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