Regulatory, Certification, and Valuation Disclaimer
InterlinkIQ™ is a proprietary Compliance and Quality Management System (CQMS) developed and operated by Consultare Inc. Group to support regulatory compliance management, documentation control, audit readiness, and accreditation preparedness.
InterlinkIQ™ does not certify organizations, does not issue regulatory approvals, and does not replace the legal responsibilities of regulated entities, including manufacturers, importers, brand owners, suppliers, or operators. All references to FDA, USDA, FSMA, GFSI, ISO, and other regulatory or certification frameworks are provided solely to describe system support, documentation alignment, and compliance-management capabilities, not to imply certification authority or regulatory endorsement.
Use of InterlinkIQ™ does not guarantee regulatory compliance, certification, audit outcomes, or inspection results. Final compliance determinations, certifications, and enforcement decisions remain the sole responsibility of the applicable regulatory authorities, certification bodies, accreditation bodies, and the regulated organization.
InterlinkIQ™ is designed to support and facilitate:
● Regulatory documentation and recordkeeping
● Internal compliance oversight and audit readiness
● Accreditation and certification preparedness
● Evidence organization and traceability
but does not act as a regulatory authority, certification body, or accreditation entity.
Professional Reliance Notice
InterlinkIQ™ is intended to be used in conjunction with qualified regulatory, quality, and compliance professionals, including FSMA Qualified Individuals, PCQIs, auditors, consultants, and legal advisors, as appropriate.
Valuation Disclaimer
The stated management-estimated market value of InterlinkIQ™ reflects internal assessments of proprietary software architecture, intellectual property, scalability, and strategic positioning as of the date published.
All valuations are estimates only and are provided for informational, strategic, and pre-investment discussion purposes. Final valuation is subject to formal appraisal, financial review, technical due diligence, market conditions, and transaction structure.
No Regulatory Endorsement
References to FDA, USDA, GFSI, ISO, Codex Alimentarius, or other standards and agencies do not imply endorsement, approval, or affiliation with those organizations.
Publication Date: 20251216
InterlinkIQ™
Regulatory-First Compliance Management System
A Core Software Asset of Consultare Inc. Group
Platform Overview
InterlinkIQ™ is a proprietary, cloud-based Compliance and Quality Management System (CQMS) developed and operated by Consultare Inc. Group to automate regulatory compliance, accreditation readiness, and audit oversight across highly regulated industries.
InterlinkIQ functions as the digital backbone of Consultare Inc. Group’s Remote Virtual Compliance Department, enabling organizations to centralize regulatory documentation, supplier compliance, training records, and audit evidence within a single, controlled, and auditable system of record.
The platform is purpose-built for environments where non-compliance results in FDA enforcement actions, USDA regulatory findings, certification failures, import disruptions, and operational risk.
Core Capabilities
Regulatory Compliance Automation
FDA FSMA Programs (21 CFR)
● Foreign Supplier Verification Program (FSVP) — 21 CFR Part 1, Subpart L
● Preventive Controls / PCQI Programs
○ Human Food — 21 CFR Part 117
○ Animal Food — 21 CFR Part 507
● HACCP-Based Programs
○ Seafood HACCP — 21 CFR Part 123
○ Juice HACCP — 21 CFR Part 120
● Current Good Manufacturing Practice (cGMP)
○ Human Food cGMP — 21 CFR Part 117, Subpart B
○ Animal Food cGMP — 21 CFR Part 507, Subpart B
● Food Defense (Intentional Adulteration) — 21 CFR Part 121
● Supply-Chain Program Management — supplier approval, verification activities, and ongoing monitoring
● Recall & Traceability Readiness
○ Recall plan documentation (21 CFR 117.139 / 507.38)
○ Traceability documentation aligned with FSMA §204 expectations
USDA Regulatory Programs
● USDA FSIS compliance support for meat, poultry, and egg products
● HACCP-based systems aligned with 9 CFR Parts 416 and 417
● Sanitation SOPs (SSOPs) and verification documentation
● Regulatory documentation readiness for USDA inspections and enforcement reviews
GFSI-Aligned & International Standards
● SQF (Safe Quality Food) Code
○ SQF Edition 9 & Edition 10
○ Applicable to Food Manufacturing, Storage & Distribution, Packaging Manufacturing, Animal Feed, and Primary Production
○Supports SQF system elements, module-based documentation, audit readiness, and continual improvement requirements
● BRCGS Global Standards
○ Food Safety
○ Packaging Materials
○ Storage and Distribution
○ Consumer Products (where applicable to supplier oversight)
○ Documentation control, internal audits, corrective action management, and certification readiness support
● FSSC 22000
○ ISO 22000–based Food Safety Management System
○ Sector-specific Pre-Requisite Programs (PRPs), including:
▸ISO/TS 22002-1 (Food Manufacturing)
▸ ISO/TS 22002-4 (Packaging Manufacturing)
○ Other applicable sector PRPs as required
○ Additional FSSC requirements, including Food Defense, Food Fraud, and Management of Services
○ Supports certification readiness, surveillance audits, and recertification cycles
● PrimusGFS (Primary Production & Packinghouse Programs)
○ Good Agricultural Practices (GAP) and Good Manufacturing Practices (GMP) for produce operations
○ Applicable to farms, harvesting operations, packinghouses, and cooling operations
○ Supports food safety plans, SOPs, records, internal audits, and PrimusGFS audit readiness
● IFS (International Featured Standards) (Global Supplier & Retail Programs)
○ IFS Food
○ IFS Logistics (where applicable)
○ Documentation control, process verification, risk assessment, and certification readiness support
○ Alignment with European retail and international supplier compliance expectations
● GlobalG.A.P. (Primary Production & Supplier Programs)
○ Good Agricultural Practices documentation and audit readiness
○ Integration with supplier verification, traceability, and risk-based monitoring workflows
● Codex Alimentarius Alignment
○ HACCP principles and risk-based food safety management alignment
○ Supports international harmonization of food safety controls, documentation, and supplier oversight
ISO Management Systems
● ISO 9001 — Quality Management Systems (QMS)
○ Organizational context, leadership, and risk-based thinking
○ Documented information control, internal audits, management review, and continual improvement
○ Corrective action tracking and performance evaluation
● ISO 22000 — Food Safety Management Systems (FSMS)
○ Hazard analysis and food safety control management
○ Integration with prerequisite programs (PRPs) and operational PRPs (oPRPs)
○ Alignment with HACCP principles and FSMA-based food safety programs
● ISO 19011 — Guidelines for Auditing Management Systems
○ Internal audit program management
○ Auditor competence tracking and audit process oversight
○ Audit planning, execution, reporting, and follow-up
● ISO 31000 — Risk Management
○ Risk identification, assessment, treatment, and monitoring
○ Integration of enterprise and operational risk into management systems
○ Supports risk-based decision-making and continual improvement
●ISO 22301 — Business Continuity Management Systems (BCMS)
○ Business impact analysis (BIA) documentation
○ Continuity and recovery planning
○ Incident response and resilience documentation support
● ISO 45001 — Occupational Health & Safety Management Systems (where applicable)
○ Hazard identification and risk controls
○ Incident reporting and corrective action workflows
○ Worker safety documentation and audit readiness
● ISO 14001 — Environmental Management Systems (where applicable)
○ Environmental aspect and impact tracking
○ Compliance obligations documentation
○ Monitoring, measurement, and continual improvement support
End-to-End Compliance Lifecycle Management
● Program setup, maintenance, updates, and reviews
● Support for FDA inspections, USDA regulatory reviews, third-party audits, and certification surveillance
Accreditation & Certification Readiness
● Structured evidence organization aligned with certification body and accreditation expectations
● Surveillance audits, recertification, and continual improvement cycle support
● Management review and corrective action tracking aligned with scheme requirements
Controlled Documentation & Records Management
● SOPs, policies, manuals, forms, and logs
● Version control, approval workflows, and controlled distribution
● Regulatory-aligned record retention and tamper-resistant audit trails
Supplier & Supply-Chain Compliance Management
● Supplier approval, onboarding, and verification workflows
● Centralized management of:
○ Certificates of Analysis (COAs)
○ Third-party audit reports
○ Product specifications
○ Allergen declarations
○ Ongoing supplier performance and compliance monitoring
Training, Qualification & Competency Management
● Role-based training assignments
● Competency tracking for PCQIs, HACCP team members, and quality personnel
● Digital certificates, refresher scheduling, and audit-ready training records
Audit Readiness & Compliance Oversight
● Internal audit support aligned with ISO 19011
● Clause-level evidence mapping to regulatory and certification requirements
● Corrective action tracking and effectiveness verification
● Historical audit trails supporting inspections and audits
Strategic Value
InterlinkIQ is not a generic document repository or horizontal QMS tool. It is a regulatory-first compliance platform engineered around real-world FDA inspections, USDA enforcement expectations, GFSI audits, and ISO certification requirements.
Its deep integration with Consultare Inc. Group’s compliance services creates:
● High client retention
● Strong switching costs
● Recurring SaaS and service-enabled revenue
Estimated Market Value
InterlinkIQ™ — Compliance Management System Software
Management-Estimated Market Value: $4,500,000
Valuation reflects proprietary software architecture, embedded regulatory logic, documentation intellectual property, scalability, and strategic value within regulated industries. Final valuation subject to formal appraisal and due diligence.
Portfolio Classification
● Asset Type: Proprietary SaaS Platform
● Primary Use: Regulatory compliance, accreditation readiness, audit management
● Market Position: Regulated-industry compliance automation
● Deployment Model: SaaS, managed services, white-label capable
● Owner: Consultare Inc. Group