Verification, Validation & Effectiveness Review Services

Compliant with 21 CFR §117.155, §117.160 & §117.165

This service provides a comprehensive framework to ensure your Food Safety Plan and Preventive Controls are effectively implemented, validated, and continuously verified in accordance with 21 CFR §117.155, §117.160, and §117.165, ensuring systems are scientifically justified, consistently executed, and audit-ready under PCQI oversight in alignment with the Food Safety Modernization Act (FSMA).

Program Objective

To establish and maintain a structured verification, validation, and effectiveness review system that:

• Confirms preventive controls are properly implemented and functioning
• Validates controls using scientific and technical evidence
• Ensures ongoing compliance with FSMA requirements
• Identifies gaps and drives corrective action and continuous improvement
• Provides defensible documentation for FDA inspections and audits

Scope of Work

1. Verification Activities (21 CFR §117.155)

• Review of monitoring activities and records
• Verification of corrective action decisions and outcomes
• Routine record review and compliance checks
• Scheduled Food Safety Plan reanalysis and updates
• Ongoing oversight by a Preventive Controls Qualified Individual (PCQI)

2. Validation Services (21 CFR §117.160)

• Pre-implementation validation of process and preventive controls
• Revalidation following process changes, deviations, or new hazard information
• Scientific justification and documentation of control effectiveness
• PCQI oversight and approval of validation activities

3. Implementation & Effectiveness Verification (21 CFR §117.165)

• Verification of consistent implementation of preventive controls
• Calibration and verification of monitoring instruments
• Environmental monitoring and product testing program oversight
• Periodic review of monitoring, corrective actions, and audit records
• Development and application of scientifically valid sampling and testing procedures

Deliverables

• Verified monitoring, corrective action, and verification records
• Validation documentation with scientific justification
• Calibration and testing program documentation
• Environmental and product testing oversight records
• PCQI-reviewed verification and validation reports
• Food Safety Plan reanalysis and effectiveness review summaries
• Audit-ready documentation and compliance reports

Ongoing Program Support

• Continuous review of records and verification activities
• Annual validation and justification reporting
• Oversight of environmental monitoring and product testing programs
• PCQI-led compliance reporting and quarterly reviews
• Corrective action review and effectiveness tracking
• FDA inspection readiness support and audit preparation

Ideal For

• FDA-regulated food manufacturers and processors
• Facilities implementing or maintaining Preventive Controls programs
• Companies preparing for FDA inspections or third-party audits
• Operations requiring scientific validation of food safety controls
• Multi-site facilities needing centralized verification and validation oversight

Program Value

• Ensures preventive controls are scientifically validated and consistently effective
• Strengthens compliance with FSMA verification and validation requirements
• Improves audit readiness through structured documentation and oversight
• Reduces risk of control failure and regulatory non-compliance
• Supports continuous improvement of food safety systems