Welcome to Assurentry! New FDA compliance features available.
Skip to main content
21 CFR 117 • FSMA Compliance

Food Safety Plan.

Stop managing binders. Build a living, digital Food Safety Plan (HARPC/HACCP) verified by a PCQI. Automated hazard analysis, preventive controls, and recall readiness.

FDA Accepted
256-Bit Encrypted
24/7 Monitoring
Food Safety Plan
PCQI VERIFIED
Hazard Analysis
Preventive Controls
Monitoring Procedures
Corrective Actions
Verification
Scanning for Hazards...
CCP Status
Critical Limit: 165°F
Current: 168°F
FSMA ENFORCEMENT ALERT: PREVENTIVE CONTROLS VIOLATIONS UP 40%
AUDIT WARNING: MISSING SUPPLY-CHAIN PROGRAM = IMMEDIATE 483
RECALL NOTICE: UNDECLARED ALLERGENS TRIGGERING CLASS I RECALLS
COMPLIANCE: PCQI SIGN-OFF MANDATORY FOR ALL PLAN UPDATES
FSMA ENFORCEMENT ALERT: PREVENTIVE CONTROLS VIOLATIONS UP 40%
AUDIT WARNING: MISSING SUPPLY-CHAIN PROGRAM = IMMEDIATE 483
RECALL NOTICE: UNDECLARED ALLERGENS TRIGGERING CLASS I RECALLS
COMPLIANCE: PCQI SIGN-OFF MANDATORY FOR ALL PLAN UPDATES
FSMA ENFORCEMENT ALERT: PREVENTIVE CONTROLS VIOLATIONS UP 40%
AUDIT WARNING: MISSING SUPPLY-CHAIN PROGRAM = IMMEDIATE 483
RECALL NOTICE: UNDECLARED ALLERGENS TRIGGERING CLASS I RECALLS
COMPLIANCE: PCQI SIGN-OFF MANDATORY FOR ALL PLAN UPDATES
Step 1

Automated Hazard Analysis.

Don't guess at risks. Our engine scans your ingredients and process steps against FDA's hazard database to identify required controls for biological, chemical, and physical threats.

FDA Database Integration
Risk Scoring (Severity x Probability)

Biological

Salmonella
Listeria
E. coli
Risk ScoreHIGH

Chemical

Allergens
Mycotoxins
Pesticides
Risk ScoreHIGH

Physical

Metal
Glass
Plastic
Risk ScoreHIGH
Receiving
Step 1
Hazards: Biological, Physical
Cold Storage
CCP 1
Hazards: Biological, Physical
Cooking
CCP 2
Hazards: Biological, Physical
Packaging
Step 4
Hazards: Biological, Physical
Visual Builder

Process Flow Diagram.

Map your production line step-by-step. Identify Critical Control Points (CCPs) exactly where they occur in your workflow.

Step 2

Preventive Controls.

HACCP is just the beginning. FSMA requires Process, Allergen, Sanitation, and Supply-Chain controls. We help you define critical limits and monitoring procedures for each.

Process
Cooking, Cooling, pH
Allergen
Labeling, Cross-Contact
Sanitation
Environment, Cleaning
Supply-Chain
Vendor Approval
Line A (Peanut Free)
Line B (Peanut)
Safe Zone
Allergen Zone
Crossover Risk
Cross-Contact

Allergen Mapping.

Define traffic patterns and segregation zones to prevent allergen cross-contact. Mandatory for facilities handling multiple allergen profiles.

Sanitation

Environmental Monitoring.

Plot your swab sites on a digital floor plan. Track trends for Zones 1-4 to catch pathogens before they reach food contact surfaces.

Eq 1
Eq 2
Eq 3
1
2
3
4
Listeria spp. Monitoring Active
Global Spices Inc.
Risk Level: Low
APPROVED
Dairy Co. Ltd.
Risk Level: High
APPROVED
Packaginator LLC
Risk Level: Med
PENDING
Vendor Approval

Supply Chain Program.

If your supplier controls the hazard, you must verify them. Track audits, Letters of Guarantee, and testing records for every approved vendor.

Step 3

The Verification Loop.

A plan is useless without proof. Our system prompts you to record monitoring data, verifies corrective actions, and validates that your controls are actually working.

Valid
Process
Monitor
Correct
Verify
Root Cause
5 Whys Analysis
Correction
Fix Implemented
Verification
Effectiveness Check
Deviations

Corrective Actions.

When a limit is breached, what happens? Our system forces a Root Cause Analysis (RCA) and tracks the corrective action to closure.

Qualified Individual

PCQI Oversight.

The Preventive Controls Qualified Individual (PCQI) must review records within 7 days. Our dashboard streamlines the review and digital signature process.

Plan Approval

I certify that I have reviewed and approved this Food Safety Plan as the Preventive Controls Qualified Individual.

Digital Signature
James Smith, PCQI
GMP BasicsAll Staff - 100%
Allergen ControlProduction - 85%
CCP MonitoringQA Team - 60%
Food DefenseSecurity - 40%
3 Certifications Expiring
Competency

Training Logs.

Personnel monitoring controls must be “qualified” to do so. Track certifications and GMP training compliance for every employee.

21 CFR 117.305

2-Year Retention.

All food safety records must be kept for at least 2 years. Our immutable cloud vault ensures you can produce records within 24 hours of an FDA request.

REC-100
REC-101
REC-102
REC-103
REC-104
REC-105
REC-106
REC-107
REC-108
REC-109
REC-110
REC-111
2-Year Retention Policy Active
New Ingredient
Trigger
Process Change
Trigger
Unforeseen Hazard
Trigger
3-Year Cycle
Trigger
Continuous Improvement

Plan Reanalysis.

Every 3 years, or whenever a significant change occurs. Our system flags “trigger events” like new equipment or unanticipated hazards that require a plan update.

Inspection

Audit Defense.

When the FDA investigator arrives, switch to “Inspector Mode.” Present a clean, organized view of your FSP without revealing proprietary trade secrets.

Messy Binder
INSPECTOR MODE
Audit Package
Generated: Just Now
Food Safety Plan
Training Logs
Monitoring Records
Corrective Actions
Mock Recall Score
98/100
Last Drill: 2 Days Ago
Traceability Speed
2h 15m
Target: < 4 Hours
Step 4

Recall Readiness.

FSMA mandates a written recall plan for every facility with a hazard requiring a preventive control. We provide the template, the contact list management, and the mock drill logs.

PCQI Power Suite

Tools designed for the Preventive Controls Qualified Individual.

PCQI Sign-Off

Digital signature workflows for plan approval.

Reanalysis Triggers

Auto-alerts when process changes require plan updates.

Audit Export

One-click PDF generation for FDA inspectors.

Platform vs. Binders.

Static Word documents can't alert you when a critical limit is breached.

Comparison
Consultants
Hourly Billing
Best Value
Assurentry
Platform
PCQI Review
Certified expert sign-off.
$250/hr
Included
Plan Updates
Keep it current.
Per Change Fee
Unlimited
Hazard Database
Auto-hazard ID.
Manual Search
Integrated
Record Keeping
Inspection ready.
Paper/Excel
Cloud Vault
Recall Management
Digital drills.
Consultant
Platform

Stop managing binders.

Build a Food Safety Plan that actually works. PCQI-verified and always audit-ready.

Frequently Asked Questions

Common questions about this regulatory requirement.

100% FDA Acceptance Guarantee

Secure Your Supply Chain.

Don't let a clerical error stop your shipment at the border. Join 2,800+ food companies who trust Assurentry for automated compliance.

256-bit Encrypted
Instant PDF
4.9/5 Rating
Official US Agent