FSVP Compliance Management System Software
Compliance Program Implementation Powered by InterlinkIQ.com Based on 21 CFR 1.500–1.514, 117, 121, and Related Requirements
To establish and maintain a centralized, digital Foreign Supplier Verification Program (FSVP) Compliance Management System for importers, brand owners, and co-packers, ensuring operational efficiency and full alignment with applicable FDA regulations including 21 CFR 117 (Subpart G), 121, 1.1315, and applicable sections of 21 USC 301.
Delivered through the InterlinkIQ.com platform, this software automates FSVP recordkeeping, supplier monitoring, risk evaluations, and compliance tracking, reducing manual workload and enhancing audit-readiness.
Scope of Work
Digital FSVP Program Management
Deploy and configure a digital Foreign Supplier Verification Program (FSVP) Compliance Management System through InterlinkIQ.com. This includes supplier profiles, risk classifications, verification activity tracking, and corrective action management within a centralized platform, compliant with 21 CFR 1.500–1.514 requirements.
Supplier Management and Risk Assessment Automation
Establish supplier records including compliance documentation uploads, verification history, and audit logs. Conduct automated supplier risk evaluations based on food safety hazards, material risks, and supplier performance following 21 CFR 117.405–117.430.
Digital Remote Supplier Verification
Support remote supplier verifications, including document reviews, risk scoring, virtual audit checklists, and corrective action issuance for high-risk suppliers, consistent with 21 CFR 117.435.
Specification Management
Manage product specifications, including raw material, packaging, labeling, and finished goods requirements in compliance with 21 CFR 117.475. Ensure updated digital records are linked directly to supplier and product profiles.
Food Defense and Traceability Documentation
Digitally maintain vulnerability assessments, mitigation strategies under 21 CFR 121.126–121.135, and traceability plans for covered foods following 21 CFR 1.1315. Ensure all records are audit-ready and version-controlled.
Corrective Action and Audit Management
Log and track supplier non-conformances, corrective actions, and closure status. Facilitate internal audits, corrective action verification, and compliance reports directly through the InterlinkIQ.com portal.
Documentation Retention and Control
Maintain traceable, version-controlled documentation for all FSVP activities, records, and verification events in alignment with 21 CFR 117.315 and 117.430. Enable easy retrieval for FDA inspections or internal compliance reviews.
Deliverables
• Configured Digital FSVP Compliance Management Portal (InterlinkIQ.com Access)
• Supplier Risk Evaluation and Verification Tracking System
• Remote Supplier Audit and Corrective Action Management Module
• Product Specification and Traceability Record Management
• Food Defense (IA Rule) Vulnerability Assessment and Mitigation Module
• Customizable Document Control Library for FSVP-Required Forms and Records
• Compliance Dashboard and Audit-Ready Reporting Tools
• User Training and Support Materials
Fees and Subscriptions
InterlinkIQ.com Compliance Software Licensing
| Service | Fee (USD) |
|---|---|
| Initial Set-Up and Configuration (One-Time Fee) | $2,950 |
| Annual Software Subscription (Includes Updates, Hosting, and User Support) | $1,950/year |
| Additional User Access (Per User) | $120/year |
| Custom Module Development (Optional) | Quoted Upon Request |
Ideal For:
• U.S. importers, brand owners, private label manufacturers, and co-packers managing multiple suppliers or product lines
• Companies seeking to digitize and automate their FSVP compliance management to streamline operations and reduce risk
• Organizations preparing for FDA inspections and requiring robust recordkeeping and audit-ready FSVP systems
• Foreign suppliers working with U.S. importers who must demonstrate verifiable FSVP compliance systems
Additional Notes
• InterlinkIQ.com is designed specifically for FSVP compliance and supply-chain program management under FSMA requirements.
• System access includes customizable templates for FSVP records, HACCP/Food Safety Plan uploads, and real-time supplier compliance monitoring.
• User permissions allow multiple compliance team members or third-party auditors to participate securely in documentation reviews and verification activities.
• Full technical support, system training, and user onboarding are included in the annual subscription.