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Remote PCQI Services for Food Safety Record Review and Approval

FDA Food Safety Record Review and PCQI Approval Services
Review and Approve Food Safety Records in Compliance with 21 CFR 117.165

Food safety records are the documented evidence that your Food Safety Plan is being implemented as designed. Under 21 CFR §117.165, monitoring records, corrective action records, verification records, and other required documentation must be reviewed within FDA-established timeframes by, or under the oversight of, a Preventive Controls Qualified Individual (PCQI).

At PCQIServices.com, we provide professional Remote PCQI Food Safety Record Review and Approval Services for food manufacturers, processors, packers, warehouses, beverage companies, ingredient suppliers, contract manufacturers, co-packers, importers, and private label brands.

Our experienced Preventive Controls Qualified Individuals (PCQIs) remotely review food safety records, verify documentation accuracy, evaluate compliance with your Food Safety Plan, identify deficiencies, and formally document record review and approval to support FDA compliance and inspection readiness.

Why Food Safety Record Review and Approval Is Important

Food safety records are often the first documents requested during an FDA inspection. They demonstrate that preventive controls were implemented, monitoring activities were completed, deviations were addressed, and verification activities were performed.

Reviewing and approving these records helps ensure:
  • • Preventive controls were implemented correctly
  • • Monitoring was completed as required
  • • Deviations were properly documented
  • • Corrective actions were appropriate
  • • Verification activities were completed
  • • Required approvals were documented
  • • Records are inspection-ready

A structured review and approval program strengthens your Food Safety Management System while reducing regulatory risk.

Why Hire a Remote PCQI?

Many facilities have excellent production personnel but do not have an experienced Preventive Controls Qualified Individual (PCQI) available to review food safety documentation within the required timeframes.

Our Remote PCQI Service provides qualified oversight without the expense of employing a full-time Food Safety Manager.

We help organizations:
  • • Review food safety records
  • • Approve preventive control documentation
  • • Evaluate monitoring records
  • • Review corrective action documentation
  • • Review verification records
  • • Identify documentation deficiencies
  • • Recommend improvements
  • • Support FDA inspection readiness
Monthly Remote PCQI Service

$750 Per Month

Includes Up to 25 Hours of Professional PCQI Support

Your monthly subscription includes:
  • • Food Safety Record Review
  • • Food Safety Record Approval
  • • Monitoring Record Review
  • • Corrective Action Record Review
  • • Verification Record Review
  • • Compliance Evaluations
  • • FDA Regulatory Consultation
  • • Virtual Meetings
  • • Email and Telephone Support
  • • Monthly Activity Reporting

Unused hours do not carry over to the following month.

Scope of Food Safety Record Review and Approval Services

Monitoring Record Review
Our Preventive Controls Qualified Individual (PCQI) reviews monitoring records to verify:
  • • Monitoring activities were completed
  • • Required frequencies were followed
  • • Critical limits were met
  • • Deviations were identified
  • • Required documentation was completed
  • • Records comply with your Food Safety Plan
Corrective Action Record Review
We review corrective action documentation to confirm:
  • • Appropriate corrective actions were implemented
  • • Product disposition decisions were documented
  • • Root cause investigations were completed
  • • Preventive measures were implemented
  • • Corrective actions were effective
Verification Record Review
Verification documentation is reviewed to ensure:
  • • Required verification activities were completed
  • • Calibration records were maintained
  • • Product testing was reviewed
  • • Environmental monitoring was evaluated
  • • Internal audits were documented
  • • Required follow-up activities were completed
Record Approval
After completing the review, our Preventive Controls Qualified Individual (PCQI) documents record approval, confirms regulatory compliance, and identifies any records requiring additional action before final acceptance.
Approval activities may include:
  • • Electronic record approval
  • • Manual record review sign-off
  • • Compliance review documentation
  • • Deficiency notifications
  • • Record approval tracking
  • • Regulatory comments
Documentation Quality Review
Our review evaluates:
  • • Completeness
  • • Accuracy
  • • Required signatures
  • • Dates and timestamps
  • • Legibility
  • • Record integrity
  • • Missing information
  • • Consistency with established procedures
Trend Analysis
Historical records are reviewed to identify:
  • • Recurring deviations
  • • Repeat corrective actions
  • • Equipment performance issues
  • • Documentation trends
  • • Employee training opportunities
  • • Supplier performance concerns
  • • Continuous improvement opportunities
Integration with Your Food Safety Plan
Food Safety Record Review and Approval supports:
  • • Hazard Analysis
  • • Preventive Controls
  • • Monitoring Procedures
  • • Corrective Action Procedures
  • • Verification Activities
  • • Validation Documentation
  • • Food Safety Plan Reanalysis
  • • Recordkeeping Requirements
This integrated approach helps ensure your Food Safety Plan remains effective, properly documented, and compliant with FDA regulations.

Deliverables

Your Food Safety Record Review and Approval engagement may include:
Record Review Documentation
  • • Food Safety Record Review Report
  • • Record Approval Log
  • • Compliance Review Summary
  • • Documentation Gap Assessment
  • • Regulatory Review Comments
  • • Trend Analysis Report
Supporting Documentation
  • • Record Improvement Recommendations
  • • Documentation Correction Requests
  • • Compliance Status Report
  • • Food Safety Plan Update Recommendations
  • • Monthly Regulatory Summary
Monthly Deliverables
  • • Monthly Activity Report
  • • Food Safety Record Review Summary
  • • Compliance Recommendations
  • • Meeting Minutes
  • • Action Item Tracker
Industries We Support
Our Food Safety Record Review and Approval services support:
  • • Food Manufacturers
  • • Beverage Manufacturers
  • • Bakeries
  • • Dairy Facilities
  • • Seafood Processors
  • • Produce Operations
  • • Frozen Food Manufacturers
  • • Ingredient Manufacturers
  • • Snack Food Companies
  • • Dietary Supplement Manufacturers
  • • Contract Manufacturers
  • • Co-Packers
  • • Importers
  • • Private Label Brands
  • • Food Warehouses

Why Choose PCQIServices.com?

Food safety records demonstrate that your Food Safety Plan is actively managed—not simply documented. During FDA inspections, record reviews often reveal whether preventive controls are consistently implemented and whether management maintains effective oversight.

Companies choose PCQIServices.com because we provide:
  • • Experienced Preventive Controls Qualified Individuals (PCQIs)
  • • FDA-focused documentation expertise
  • • Timely remote record reviews
  • • Practical compliance recommendations
  • • Facility-specific support
  • • Affordable monthly service
  • • Nationwide and international remote consulting
  • • Ongoing regulatory guidance

Our objective is to help your organization maintain complete, accurate, and FDA-compliant food safety records that support operational excellence and inspection readiness.

Frequently Asked Questions

Why should food safety records be reviewed and approved? Food safety records should be reviewed to confirm that preventive controls were implemented correctly, documentation is complete, deviations were addressed, and FDA recordkeeping requirements have been met. Who should review food safety records? Monitoring records, corrective action records, verification records, and other preventive control records should be reviewed by, or under the oversight of, a Preventive Controls Qualified Individual (PCQI) within the timeframes required by FDA regulations. What food safety records should be reviewed? Typical records include:
  • • Monitoring Records
  • • Corrective Action Records
  • • Verification Records
  • • Calibration Records
  • • Product Testing Records
  • • Environmental Monitoring Records
  • • Internal Audit Records
  • • Product Release Records
  • • Supplier Verification Records
Can food safety records be reviewed remotely? Yes. Our Remote PCQI Services allow secure electronic review and approval of food safety records using digital document management systems or scanned records. How much does your Food Safety Record Review and Approval service cost? Our Remote PCQI Service is $750 per month and includes up to 25 hours of professional support for food safety record review, approval, regulatory consultation, and ongoing Food Safety Plan oversight.

FDA Regulation

21 CFR §117.165 – Verification and Record Review Under 21 CFR §117.165, facilities must review monitoring records, corrective action records, verification records, and other Food Safety Plan documentation within established timeframes to confirm preventive controls are consistently implemented and records are complete, accurate, and compliant with FDA requirements.
Record reviews should confirm:
  • • Monitoring records were reviewed within required timeframes
  • • Corrective action records are complete and appropriate
  • • Verification records demonstrate ongoing Food Safety Plan implementation
  • • Documentation is complete, accurate, and properly maintained
  • • Records comply with applicable FDA Preventive Controls requirements
Our Remote PCQI Food Safety Record Review and Approval Service provides qualified oversight that supports regulatory compliance, strengthens documentation practices, and prepares your facility for FDA inspections.

Request a Free Consultation

Need an experienced PCQI to review and approve your food safety records?

Partner with PCQIServices.com for professional Remote PCQI Food Safety Record Review and Approval Services and receive ongoing regulatory oversight from experienced Preventive Controls Qualified Individuals (PCQIs).

Remote PCQI Service

$750 Per Month

Up to 25 Hours of Professional PCQI Support

➜ FDA-Compliant Food Safety Record Review and Approval
➜ Monitoring, Corrective Action, and Verification Record Oversight
➜ Experienced Preventive Controls Qualified Individuals (PCQIs)
➜ Nationwide & International Remote Service

Contact us today to schedule your free consultation and strengthen your Food Safety Plan through professional record review and approval.

Fees and Subscriptions

Initial Setup Fees

Plan Description One-Time Fee
CAP Lite 1 corrective action plan template + logbook $650
Standard Incident Response Pack Full CAP program + training + food safety reanalysis trigger tool $1,500
Comprehensive CAP Suite Includes RCA tools, CAP/Correction integration, and food disposition support $2,800

Monthly Maintenance Fees

Plan Monthly Maintenance Monthly Fee
Standard Quarterly incident review support + minor template updates $250/month
Premium Monthly review of CAP logs + RCA support + retraining access $500/month
Enterprise Incident investigation support, real-time CAP guidance, compliance alerts, and food safety plan reanalysis support $850/month

Monthly Maintenance Coverage Includes

  • • Review and feedback on submitted corrective action reports
  • • Root cause analysis consultation and corrective/preventive action refinement
  • • Monthly summary of trends, repeated incidents, and improvement suggestions
  • • Update of CAP templates based on FDA guidance or internal audit findings
  • • Support for food safety plan reanalysis when required (per §117.170)
  • • Email and chat access for urgent compliance queries or incident reporting

Ideal For:

  • • Facilities with ready-to-eat (RTE) foods and pathogen monitoring requirements
  • • Manufacturers preparing for FDA audits and needing proactive incident management
  • • QA teams requiring structured response to food safety deviations or failures
  • • Private labelers and co-manufacturers who need documented corrective action responses for client assurance

Need Expert PCQI Support?

Partner with our experienced Preventive Controls Qualified Individuals (PCQIs) for practical FDA compliance guidance, documentation support, Food Safety Plan development, regulatory consulting, and ongoing compliance services tailored to your operation.