1331 Pine Trail

Tomball TX 77375

202-982-3002

Info@consultareinc.com

ALL INCLUSIVE SERVICES

Food Safety, Quality Assurance, Regulatory, Certification, and Compliance Services

Design to support your regulatory, accreditation, and certification compliance.

Introduction video

Compliance Services

REGULATORY

21 CFR Part 110 – cGMP in Manufacturing, Packaging, or Holding Human Food

21 CFR Part 117 – cGMP Hazard Analysis, and Risk-Based Preventive Controls for Human Food

  • General Provisions
  • Applicability
  • Status
  • Definitions
  • Qualifications
  • Exemptions
  • Facilities
  • Off Farm
  • Off Farm
  • Packing
  • Holding
  • Records Requirements

STANDARDS

Requirements Applying to Records That Must Be Established and Maintained
  • General Requirements Application
  • Food Safety Plan Requirements
  • Record Retention
  • Official Review
  • Public Disclosure
  • Use of Existing Records
  • Special Requirements Applicable to A Written Assurance
Current Good Manufacturing Practice
  • Personnel
  • Plant and Grounds
  • Sanitary Operations
  • Sanitary Facilities and Controls
  • Equipment and Utensils
  • Processes and Controls
  • Warehousing and Distribution
  • Holding and Distribution of Human Food By-Products for Use as Animal Food
  • Defect Action Level
Hazard Analysis and Risk-Based Preventive Controls
  • Food safety plan
  • Hazard Analysis
  • Preventive Controls and Management Components
  • Assurance’s Requirements
  • Recall Plan
  • Monitoring
  • Corrective Actions and Corrections
  • Verification
  • Validation
  • Reanalysis
  • PCQI Requirements
  • Qualified Auditor Requirements
  • Records Implementation
Modified Requirements
  • Qualified Facility Application
  • Unexposed Packaged food and Storage
Supply-Chain Program
  • Establishment and Implementation
  • General Requirements
  • Receiving Facility Responsibilities
  • Using Approved Suppliers
  • Supplier Verification Activities and Frequency
  • Supplier Raw Materials and Ingredients Verification
  • Onsite Audit
  • Supply-Chain Program Records

ACCREDITATION & CERTIFICATION

  • ACFS – National Bureau of Agricultural Commodity and Food Standards
  • ANAB – ANSI ASQ National Accreditation Board
  • ANSI – American National Standards Institute
  • BRCGS – British Retail Consortium Global Standards
  • FSSC 22000 – Food Safety System Certification 22000
  • GFSI – Global Food Safety Initiative
  • GMP – Good Manufacturing Practices
  • HACCP – Hazard Analysis Critical Control Point
  • IAS – International Accreditation Services
  • ISO 22000 Food Safety Management
  • PrimusGFS
  • SQF – Safe Quality Foods

SOFTWARE, IT, & COMPLIANCE PROGRAMS

PRP

Prerequisite Programs

ETRR

Employee Training Requirements and Records

RVVMP

Records Verification and Validation Management Program

CAMP

Corrective Action Management Program

PMP

Preventive Maintenance Program

QCMS

Quality Care Management Program

CCMS

Customer Care Management Program

SOP Pro

(PFL) Programs, Policies, Procedures, Forms for Records, Lessons for Training.

PMS

Project Management System

ICMS

Inventory Control Management System

IAMP

Internal Audit Management Program

SAMP

Supplier Approval Management Program

CMP

Complaint Management Program

LMS

Learning Management System

QAS

Quality Assurance Services

OTHER IT PROJECTS

Website, Web Application Development, & Graphic Design (Static Website Creation, WordPress Development, Website Maintenance & Update, E-commerce, IT Business Solutions, Database Management, Process Automation, Logo Designs, and Graphics for Marketing and Training Materials).

About Us

Developed by Consultare Inc., a compliance company that provides Quality Care Management Systems (QCMS), Quality Systems (QS), Quality Management Systems (QMS), Regulatory and Certification Prerequisite Programs (PRP’s). 

Our foundation is in developing and implementing Programs, Policies, Protocols, Procedures, Forms for Records, and Lessons for Training regulated by the Code of Federal Regulations (CFR), and surveyed by accreditation bodies.

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