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Monthly PCQI Oversight and End-to-End Compliance Support

Ongoing Compliance Management for Food Facilities

For facilities that require continued guidance, hands-on maintenance, and real-time support beyond the initial GMP and Food Safety system setup and/or certification, our Monthly End-to-End Support package provides full-spectrum, proactive compliance management under the oversight of a qualified individual (PCQI), aligning with all the applicable FDA standards per U.S. Code of Federal Regulations.

 

This service ensures your facility remains audit-ready, fully compliant, and capable of adapting to operational changes, new products, or evolving regulatory expectations—all with expert oversight and minimal internal resource strain.

Ideal For:

  • ✓ Food or beverage manufacturers (U.S. and international)
  • ✓ Dietary supplement co-manufacturers producing food-type products
  • ✓ Contract manufacturers servicing high-compliance buyers
  • ✓ Facilities with limited internal QA or compliance staff

Scope of Work

A. GMP Program Oversight and Documentation Management

1. Maintain and update existing SOPs and related documents based on:

  • • Client operational or process changes
  • • Corrective and Preventive Action (CAPA) Plans
  • • Regulatory updates
  • • Industry best practices

2. Review, revise, and draft required Standard Operating Procedures (SOPs), forms, checklists, and training lessons to ensure they align with the requirements.

3. Manage the client’s document control system:

  • • SOP version tracking
  • • Issuance and discard control

4. Review client-provided records and GMP documentation for completeness and consistency.

B. Training and Competency Development

1. Provide virtual refresher training and comprehension quizzes for personnel based on industry best practice (if applicable).

2. Maintain and update the client’s training matrix and records.

3. Provide guidance on delivery and documentation of employee training activities.

C. Facility and Operational Monitoring Support

1. Review monthly sanitation logs and pest control records.

2. Verify equipment preventive maintenance and calibration schedules and records.

3. Review environmental monitoring logs and corrective actions (if applicable).

4. Assess facility based on client-provided information on the following areas:

  • • Sanitation facility conditions
  • • Equipment layout and storage practices

D. Recordkeeping System Oversight

1. Review recordkeeping forms and logs for compliance with Subpart F, including:

  • • Temperature logs
  • • Cleaning and sanitation logs
  • • Maintenance and calibration records
  • • Pest control reports

2. Provide recommendations for correction of record deficiencies.

3. Advise on best practices on record archiving for FDA inspection readiness.

4. Secure client approval for all new or revised documentation before release.

E. FDA Inspection and Audit Preparedness

1. Assist in the preparation of documents prior to audits.

2. Provide remote support during audits.

3. Provide corrective action recommendations and draft SOPs, where applicable.

4. Support the investigation, root cause analysis, documentation, and closure of non-conformances identified through internal audits, third-party audits, or client incidents.

5. Serve as virtual liaison support during actual FDA or customer audits.

F. Regulatory and Industry Advisory Services

1. Notify client of changes to FDA regulations or applicable GMP standards.

2. Provide quarterly compliance summary reports detailing:

  • • Status of documentation
  • • Recordkeeping findings
  • • Training compliance
  • • Operational improvement recommendations

3. On-demand consultation for GMP-related inquiries, non-conformances, or operational changes.

G. Client Communication and Reporting

1. Routine summary reports outlining compliance status, improvements, and potential risks.

2. Scheduled virtual meetings (i.e., weekly/monthly/bi-monthly) to review progress, resolve open items, and plan for future improvements.

H. HACCP/Food Safety Plan/Preventive Controls (PCQI Role Support), (applicable if implementing HACCP/HARPC programs)

1. Act as the client’s Preventive Controls Qualified Individual (PCQI).

2. Develop, implement, and manage the client’s Food Safety Plan, including:

  • • Hazard analysis
  • • Preventive controls determination
  • • Validation and verification activities
  • • Monitoring procedures
  • • Corrective actions and reanalysis
  • • Record review and sign-off

3. Direct execution of food safety activities, including:

  • • Approval or rejection of suppliers based on supply-chain program criteria.
  • • Oversight of supplier verification activities, including documentation review and risk assessment.
  • • Oversight of implementation of preventive control programs (e.g., allergen, sanitation, process controls).
  • • Review and approval of product release and recall programs.

I. FSMS Software Management (optional, if Software is availed), which may include but are not limited to the following:

1. Document Control

  • • Upload, organize, and maintain controlled documents and records.
  • • Track document revisions, approvals, and distribution.
  • • Manage compliance action items for routine verification and reviews.

2. Audit Management

  • • Set up internal audit schedules.
  • • Log audit findings, non-conformances, and track resolution status.

3. Corrective and Preventive Action (CAPA) Management

  • • Document the CAPA process: issuance, root cause analysis, correction, and closure documentation.

4. Training Management

  • • Upload training records.
  • • Monitor training status, validity, and expiration.
  • • Assign training to applicable personnel.

5. Supplier/Vendor Management

  • • Maintain supplier approval status, documentation, and performance records.
  • • Track supplier non-conformances and corrective actions.

6. Risk Assessment and Mitigation

  • • Document food safety risk assessments (HACCP, food fraud, food defense).
  • • Track mitigation strategies and update assessments as needed.

7. Monitoring and Verification

  • • Review PRP/CCP/PC monitoring activities.

8. Customer Complaint Management

  • • Document complaints, investigations, and resolutions.
  • • Analyze trends and recommend improvements.

Deliverables

  • • Updated GMP SOPs, forms, checklists, and training materials with comprehension quizzes (editable Word/PDF formats)
  • • Master document control register with version control
  • • Document revision logs with change history reporting
  • • PCQI-reviewed SOPs (with sign-off when applicable)
  • • Recordkeeping compliance checklist aligned with Subpart F – Recordkeeping Requirements
  • • Filing system recommendations and/or updates (electronic or physical)
  • • Routine compliance reports including document updates and control status, record review summary, training updates, and outstanding issues or risks
  • • PCQI-reviewed Food Safety Plan aligned with Subpart C – HARPC (if applicable)
  • • Supplier Approvals with compliance status (if applicable)
  • • Preventive Control Validation Records (if applicable)
  • • Corrective action plans, if any Summary emails or logs documenting reviews, approvals, and actions taken

Pricing

Package Name Monthly Service Hours Monthly Investment
Core Compliance Support 100 $2,500
Elite Compliance Assurance 150 $3,600
Advanced Compliance Package 200 $4,600
Premium Compliance Partnership 300 $5,700

Optional Add-Ons:

  • • HACCP/Food Safety Plan Development (Project-based) – $2,200.00 per product (Includes full HACCP plan, hazard analysis, CCPs, and validation)
  • • On-Site Support Visit (w/ in-person implementation coaching) – $1,200.00/day + miscellaneous
  • • Audit Readiness Gap Assessment (remote) – $4,750.00/facility
  • • Audit Readiness Gap Assessment (onsite) – $4,900.00/facility + miscellaneous
  • • cGMP/HARPC Compliance Management System Software – starts at $99/mo per user
  • • Foreign Supplier Verification (FSVP) End-to-End Compliance Management – starts at $249 per month

Why Choose Our Monthly Support?

  • ✓ Keep your cGMP and/or Food Safety system alive, dynamic, and audit-ready.
  • ✓ Reduce internal resource burden while staying fully compliant.
  • ✓ Gain peace of mind with ongoing expert oversight and risk management.

Get Started: Contact us at info@consultareinc.com or submit your request via our online form.