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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: FDA-compliant quality and food safety system for brand owners 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

Who This Program Is For

  • • Brand owners relying on co-manufacturers, private labelers, or contract packers
  • • Companies without in-house production facilities but responsible for compliance
  • • Importers of food, beverages, or dietary supplements subject to FSVP
  • • Businesses preparing for FDA inspections, distributor onboarding, or audits

Scope of Work

A. Supplier & Contract Manufacturer Compliance

  • • Development of supplier approval and verification programs aligned with 21 CFR §117.410
  • • Supplier evaluation tools, risk scoring, and approval tracking systems
  • • Product and packaging specification templates aligned with regulatory requirements
  • • Internal audit program for co-manufacturer oversight and performance monitoring
  • • Quality agreement templates defining roles, responsibilities, and compliance expectations
  • • Food Fraud Vulnerability Assessment (FFVA) aligned with 21 CFR Part 121
  • • Record retention and document control systems aligned with 21 CFR §117.315

B. Product Compliance & Risk Management Programs

  • • Label and product version control systems to manage regulatory updates
  • • Traceability program aligned with 21 CFR §1.1315
  • • Product withdrawal and recall program with defined roles and procedures
  • • Customer complaint handling and trend analysis system
  • • Crisis management procedures for food safety incidents and regulatory events
  • • HACCP or Food Safety Plan templates including hazard analysis and control identification

C. Optional FSVP Compliance Setup (For Importers)

  • • Development of a compliant Foreign Supplier Verification Program (FSVP) structure
  • • Foreign supplier evaluation and risk-based verification tools
  • • Emergency supplier approval procedures
  • • Food defense assessment tools for foreign suppliers
  • • Guidance on FSVP importer responsibilities and registration requirements

Deliverables

1. Recordkeeping Structure Development

  • • Design of compliant templates (Food Safety Plans, monitoring, corrective actions, verification)
  • • Creation of a comprehensive records matrix linking documentation directly to regulatory requirements
  • • Standardized logging formats to maintain consistency across facility operations

2. Food Safety Plan Documentation Controls

  • • Guidance on required signatures and owner/operator approvals under 21 CFR §117.310
  • • Record control checklists ensuring completeness, legibility, and full traceability
  • • Version control procedures for managing document revisions, historical archives, and re-approvals

3. Record Retention & Storage System

  • • Development of retention policies aligned with 21 CFR §117.315
  • • Minimum two-year retention framework with protocols for extended record requirements
  • • Archiving protocols for validation studies and discontinued process documentation
  • • Secure digital backup and retrieval strategies supporting rapid FDA access requirements

4. Electronic Record System Integration

  • • Guidance for implementing electronic records in compliance with 21 CFR §117.305
  • • Alignment with FDA electronic signature and record expectations (including 21 CFR Part 11)
  • • Mapping digital workflow systems to preventive controls regulatory mandates

5. Written Assurance Documentation

  • • Preparation of legally compliant customer written assurances under 21 CFR §117.335
  • • Standardized assurance templates incorporating effective dates, scopes, and authorized signatures
  • • Defined terms for annual maintenance, verification responsibilities, and contract termination

6. Records Review & Gap Closure

  • • Audit checklists to verify records capture actual values, critical limits, and operator sign-offs
  • • Systematic identification, documentation, and correction of recordkeeping deficiencies
  • • Action plans for reorganizing or supplementing legacy records to meet audit standards

7. Inspection & Audit Readiness

  • • Organization of physical and cloud-based filing architectures for rapid document retrieval
  • • Standard operating procedures to ensure records are accessible within the 24-hour FDA inspection window
  • • Structured index frameworks aligned directly with third-party audit schemes and regulatory expectations

Ongoing Program Support

  • • Continuous review of recordkeeping practices and documentation quality
  • • Monthly compliance checks and feedback on records
  • • Updates to templates based on regulatory changes or audit findings
  • • Support for transitioning from paper-based to digital systems
  • • Guidance on maintaining audit-ready documentation at all times

Ideal For

  • • Food manufacturers and processors preparing for FDA inspections
  • • Facilities transitioning to electronic recordkeeping systems
  • • Importers and co-packers managing multi-party compliance documentation
  • • Operations with complex documentation or written assurance requirements
  • • Multi-site facilities requiring centralized record control systems

Program Value

  • • Ensures full compliance with FSMA recordkeeping requirements
  • • Improves traceability, accuracy, and accessibility of records
  • • Strengthens audit readiness and inspection performance
  • • Reduces compliance risk through structured documentation systems
  • • Supports scalable and digital-first compliance management

Pricing and Timeline

Setup Tier Timeline Price
Standard Brand Owner Setup (w/o FSVP Requirements)
for 1 local supplier and 1 product		 60 to 75 business days $4,800 per facility
Importer-Brand Owner Setup (w/ FSVP Requirements)
for 1 foreign supplier and 1 product		 70 to 80 business days $5,950 per facility
Add-on: Supply-chain/FSVP Compliance Assessment
for additional supplier/s		 5 to 10 business days + $249 per additional supplier
Add-on: FFVA Set-up for additional product/s 5 to 10 business days + $129 per additional product
Add-on: Supply-chain/FSVP and FFVA Set-up
for 2 or more suppliers and/or products		 Varies Custom quote
Add-on: Monthly Brand Owner Full Compliance Support – Starts at $2,500 per month

Ready to Get Compliant?

Whether you are launching a new product or aligning an existing brand with FDA requirements, our Brand Owner Compliance Setup Package gives you a turnkey, audit-ready documentation system—customized to your product and supplier. Contact us today to get started or request a tailored proposal. Our team will guide you through each step and ensure your setup meets U.S. regulatory expectations with confidence.

Need Expert PCQI Support?

Partner with our experienced Preventive Controls Qualified Individuals (PCQIs) for practical FDA compliance guidance, documentation support, Food Safety Plan development, regulatory consulting, and ongoing compliance services tailored to your operation.