Verification, Validation & Effectiveness Review Services
Compliance with 21 CFR §117.155, §117.160, and §117.165
The purpose of this service is to ensure ongoing compliance with FDA requirements under 21 CFR §117.155, §117.160, and §117.165 by providing structured verification, validation, and implementation effectiveness review activities. This service helps food facilities maintain scientifically sound, audit-ready food safety systems through continuous oversight by Preventive Controls Qualified Individuals (PCQIs), comprehensive documentation, and targeted corrective action support—ensuring food safety plans are not only implemented, but proven effective.
Scope of Work
1. Verification Activities (§117.155)
We provide continuous verification services aligned with your food safety plan and preventive controls, including:
- • Monitoring reviews
- • Corrective action decision verification
- • Record reviews
- • Scheduled reanalysis and updates
- • Oversight by Preventive Controls Qualified Individuals (PCQIs)
2. Validation Services (§117.160)
Our team ensures your preventive controls are validated with scientific and technical support. Activities include:
- • Pre-implementation validation of process controls
- • Revalidation upon process changes or findings
- • Documentation of evidence and justifications
- • PCQI oversight of validation activities
3. Implementation & Effectiveness Verification (§117.165)
We help verify that controls are implemented consistently and effectively, using:
- • Calibration of monitoring and verification instruments
- • Environmental monitoring and product testing programs
- • Periodic reviews of monitoring, corrective actions, and audit records
- • Scientifically valid procedures for sampling, testing, and lab documentation
Fees and Subscriptions
Monthly Maintenance Support Inclusions
- • Ongoing Record Review & Verification
- • Annual Validation & Justification Reporting
- • Environmental & Product Testing Plan Oversight
- • PCQI Oversight & Quarterly Reports
- • Corrective Action Documentation Review
- • FDA Audit Readiness Support
Monthly Service Fee
Standard Monthly Plan: $950/month
- • Includes remote record verification, PCQI oversight, quarterly updates, and compliance reporting.
- • Includes all Standard services plus validation support, annual plan reanalysis, and audit-prep simulations.
- • Tailored for multi-facility operations requiring integrated validation programs, comprehensive monitoring reviews, and on-site support.