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Compliance Begins with ConformanceWare®

OUR COMMITMENT
Our focus is to protect the general public and safeguard the purity of cannabis used for medicinal purposes and the production of goods in the Cannabis Industry.  Applying our vast experience in the areas of compliance and conformance, we provide the means and documentation required to ensure the Quality, Safety and Efficiency of cannabis products.

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Safe Cannabis Demands Compliance/Conformance

Cannabis has an extensive history and even to this day, science continues to discover new uses and health benefits. To ensure public health and safety, governmental bodies establish specific industry controls to which businesses must legally comply.

Getting your business to operate in total compliance/conformance can be quite the task. Being new to the process or not having the time to sort through and make sense of so much technical and legal data is both complex and overwhelming.

We are here to help.

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Public Health and Safety
Must Come First

With this in mind, standardization is critical because lawmakers turn to single or multiple standards to define operational requirements for establishing controls found in written regulations.

Various agencies (Federal, State, Local) then enforce these regulations by performing inspections to verify compliance. Similarly, accredited third-party assessment bodies verify conformance and/or compliance to various industry standards when certification, accreditation and industry recognition is the goal.

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Take Action
- Be Proactive -

Being proactive will secure your business and put you in a very strong position. Especially when having to navigate the complexities of regulatory requirements and the eventual changes coming with Schedule II.

Staying ahead of the curve requires using best practice methodologies to achieve regulatory compliance and conformance to standards. In so doing,
you will minimize risk,
save time and money
and finally get some
peace of mind.

ConformanceWare Medical Cannabis [MC] Series

 

ConformanceWare Medical Cannabis [MC] Series

Medical Cannabis - MC Series

Now available is the ConformanceWare® Medical Cannabis Series developed strictly for the cannabis industry. The MC Series is designed to simplify the entire compliance/conformance process because we’ve done most of the work for you. It delivers a true turnkey solution that provides the required documentation you need with a way to manage it.

FLEXIBILITY TO MEET YOUR NEEDS

The MC Series does a great job merging regulatory best practices with internationally accepted standards to develop, customize and format the required documentation. All documentation is customized for your business model and written in clear language using the proper terminology that inspectors and auditors have come to expect.

ConformanceWare Medical Cannabis [MC] Series

BE PROACTIVE

Minimize risk and secure your business by ensuring that you meet all of the applicable operational and regulatory requirements.

Reserve your spot with us now and be prepared.

Series Essentials

The MC Series emphasizes affordability and is designed to enable any-sized organization to make the investment with confidence. Each edition offers all the essentials found in a true turnkey package: A method to meet the applicable requirements, full consulting support for implementation and easy access for documentation control and storage with a way to manage your office activities.

DOCUMENTATION

Includes: Policies, Processes, Supporting Processes, Procedures, SOPs (Standard Operating Procedures or instructions), Instructions and Forms

CONSULTING

AIM Program for achieving total Compliance/Conformance in 45 Business Days or Less

CLOUD

Secure Private Portal, Links to Track/State Reporting software, Document Viewer/Editor, CRM

Medical Cannabis [MC] Series Architecture

MC SeriesArchitecture

Daily operations require a way to easily navigate and manage all of your documentation. The architecture of the MC Series includes pre-defined file directories with three key components:

Everyday Docs, Mentor and Tech Tools

BE PROACTIVE

Minimize risk and secure your business by ensuring that you meet all of the applicable operational and regulatory requirements.

Reserve your spot with us now and be prepared.

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Specific Editions for What You Do

The MC Series is flexible and offers a variety of options. Each product edition specifically targets your area of discipline within the cannabis industry lifecycle. Upon selecting your edition and through our process, we customize it to ensure your current operation meets the necessary requirements. This includes applicable EPA-FDA regulations, State requirements, Standards and/or Guidelines.

MC Series - GROW

GROW

This edition delivers the proper documentation and support guidance for operations performing cultivation of cannabis in meeting their applicable agricultural/collection regulations and requirements.

Designed for:

Cultivators | Growers


 

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PROCESS

This edition delivers the proper documentation and support guidance for operations performing various manufacturing processes of cannabis products in meeting their applicable regulations and requirements.

Designed for:

Extractors | Infused Product Manufacturers/Food Processors | Packaging | Labeling | Holding

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DISPENSE

This edition delivers the proper documentation and support guidance for operations performing consumer distribution of cannabis products in meeting their applicable regulations and requirements to ensure public health and safety.

Designed for:

Dispensaries | Distributors | Retail suppliers

 

The Technical Side

The MC Series will assist to ensure safe cannabis products and meet your legal challenges. Scalable to your operation, it offers a way to meet requirements while growing your business. To fully support your compliance/conformance efforts, each MC Series™ Edition is a Quality Management System (QMS) structured to follow ISO Annex SL using a variety of applicable resources:

  • CURRENT STATE REQUIREMENTS
  • USDA – cGAP
  • EPA – GMP, GLP
  • FDA – cGMP, cGLP, CMC BOTANICAL
    (21 CFR PARTS 58, 110-111, 117, 210-211, 312)
  • ASTM D37 Cannabis Industry Standards & GAP/GMP Best Practices
  • Food Safety Modernization Act (FSMA)
    HACCP, Food Safety Plan (cGAP, cGMP specific to 21CFR 111 [dietary supplements], 117 [food]), ISO 9001/22006
  • FSSC 22000
    [Global Food Safety Initiative (GFSI)]
  • SQF (Safe Quality Food) Code - Edition 9
    A HACCP-Based Supplier Assurance Code for the Food Industry
  • Perry Johnson Registrars Food Safety, Inc. (PJRFSI)
    PJRFSI Cannabis Safety Standard for Cultivation, Manufacturing & Retail
  • Cannabis Safety and Quality (CSQ)
    CSQ Cannabis Safety and Quality Standard for Retail, Cultivation, Manufacturing/Extraction, Infused Food/Beverage & Dietary Supplements
  • Cannabis Authenticity and Purity Standard (CAPS)
    Algins with regulatory & safety requirements for Health Canada, FDA/CFR 117,    ISO 9001, ISO 22000

  • BRC (British Retail Consortium) - Issue 9
  • Foundation of Cannabis Unified Standards (FOCUS)
  • AHPA GUIDELINES
    (American Herbal Products Association)
  • ICH GUIDELINES
    Q7 - Q9 - Q10
  • WHO GUIDELINES
    GACP - GMP - GLP
  • ISO/IEC 17025:2017
  • 2009 TNI STANDARD
  • ISO 22000
  • ISO/TS 22002-1
  • ISO 15378:2015
  • ISO 14971:2007
  • ISO 9001:2015
  • ISO 14001:2015
  • ISO 45001:2018
  • CUSTOM CERTIFICATION BODY PROGRAM FOR ACCREDITATION
  • ISO/IEC 17065:2012 Conformity Assessment - Requirements for bodies certifiying products, processes and services.

Be Proactive

Minimize risk and secure your business by ensuring that you meet all of the applicable operational and regulatory requirements.

Reserve your spot with us now and be prepared.