Why is quality important in the cannabis industry?

Quality is essential in the cannabis industry to meet evolving standards, stand out in the market, and ensure compliance. Prioritizing quality helps meet consumer expectations, ensures traceability, enhances product safety, prevents legal issues, and fosters repeat business.

Who regulates cannabis manufacturing in the United States?

Cannabis regulation in the U.S. is primarily managed at the state level, though the FDA oversees cannabis used for medical purposes. Many cannabis companies also adopt GMP or ISO 9001 standards to ensure quality and compliance. Legal requirements vary by jurisdiction and should be verified with legal counsel.

What is the benefit of using cannabis quality management software?

Cannabis QMS software centralizes quality management, automates workflows, and synchronizes documentation. It helps companies manage risk, reduce costs, ensure compliance, improve communication, and streamline processes like supplier and document control.

Why choose QT9 QMS for your cannabis quality management needs?

QT9 QMS offers over 25 standard modules including Document Control, Risk Management, and Audit Management. It is cloud-based, scalable, easy to use, and integrates with ERP and BI tools to provide real-time insights and full traceability with customer support included.

Cannabis Quality Management Software

GMP Compliance Ready

Batch-Level Traceability

Digital SOP Control

Audit-Ready Records

Varying Regulations

Navigate a patchwork of local, state and federal guidelines.

Document Control

Centralize and automate approvals and version control.

Traceability

Built-in, lot-level traceability and nonconformance controls.

Document Control

Automate approvals, version control and distribution in accordance with regulations.

Batch & Lot Traceability

Trace every product and ingredient for full accountability.

CAPA Management

Streamline corrective and preventive actions with automated workflows.

Audit Management

Plan and track all quality audits with real-time status dashboards.

Change Management

Control and document all changes with built-in workflows.

Employee Training

Assign and verify training with electronic tracking and reminders.

Risk Management

Reduce cannabis recall risk with built-in risk management tools.

Complaint Handling

Log, investigate and close complaints faster with built-in escalation.

Equipment Calibration

Track equipment calibration schedules and maintenance history.

Ensure electronic records and signatures meet Part 11 standards

Secure electronic signatures and audit trails
Time-stamped record tracking
Access controls per user role
Immutable change history

Explore FDA 21 CFR Part 11

Map your cannabis QMS to GMP and state regulatory needs

Embed state rule variations dynamically
Align SOPs with GMP requirements
Automate regulatory checklist updates
Maintain audit logs per jurisdiction

Explore GMP

Control SOP changes and version revisions transparently

Route change requests with approvals
Track document versions by date/user
Link changes to impacted batches
Maintain full version control history

Explore Change Control

Use real-time metrics to monitor cannabis quality

Dashboards on defects, drift, yield
Trend analysis for nonconformances
KPI alerts on quality thresholds
Compare metrics across product lines

Explore Features

Ensure staff certification is current and traceable

Assign training per role and SOP
Automatically alert recertification needs
Verify competency before tasks
Store digital certificates and logs

Explore Employee Training

ISO 9001

International Quality Management System Standards

FDA 21 CFR Part 11

cGMP for Dietary Supplements

Pre-validated QMS software

QT9 QMS is pre-validated for accelerated compliance.

FDA and ISO compliance out-of-the-box
Rapid cloud deployment for faster implementation
Audit-ready with timeline traceability
Electronic signature approvals and secure access controls
Continuous validation and updates

• ISO 13585
• ISO 9001
• ISO 14001
• ISO 17025
• AS9100
• MoCRA

• FDA 21 CFR Part 11
• FDA 21 CFR Part 210/211
• FDA 21 CFR Part 820
• EU GMP
• EU MDR
• GxP Compliance

QT9 QMS includes a complete execution of all protocols, including Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ).

Eliminates costly internal QMS validation efforts that can take months of staff time or cost thousands in consultant fees.
Reduces downtime waiting for your QMS to be approved for use.
Minimizes the risk of any failed audits due to flawed validation protocols.

FAQ: Cannabis Industry

The cannabis industry is quickly evolving, so ensuring your company stands out for quality and is prepared to meet all applicable standards and regulations is vital. By prioritizing quality your company can:

Make it easier to meet consumer expectations
Enable full traceability of any process
Optimize product safety and consumer health
Quickly comply with regulations
Prevent legal penalties and potential recalls
Develop repeat business
Stand out in the market

Because cannabis is not legal at the Federal level in the United States, regulatory requirements fall to the individual states. Cannabis businesses and organizations should educate themselves about all federal and state laws.

Regulation of cannabis for medical use falls under the jurisdiction of the U.S. Food and Drug Administration (FDA). “The FDA’s role in the regulation of all drugs, including cannabis and cannabis-derived products, also includes review of applications to market drugs to determine whether proposed drug products are safe and effective for their intended indications.”

In the interest of providing safe and effective products, many cannabis companies have adopted quality guidelines put forth by general manufacturing practice (GMP) or ISO 9001 standards. ISO 9001 outlines criteria for any organization establishing a quality management system. You can find more about ISO 9001 standards by visiting our ISO 9001 page.

It is important to note that the legality of cannabis, whether for recreational or medical use, varies by country and can be industry dependent. For additional information on the legal status of cannabis in various countries, the following Wikipedia article may help: Cannabis Legality *

* Disclaimer: This information is provided for educational purposes only and not as legal advice or opinion. The reader retains full responsibility for the use of the information contained herein. Any reader seeking a determination of legal rights should seek the counsel of an attorney or designated official of the applicable regulating agency.

Cannabis QMS software provides a centralized platform for managing quality, automating workflows and synchronizing documentation. With an automated quality management system, cannabis companies can integrate and streamline quality processes, including document control, risk management and supplier management. Automation brings efficiencies that enable businesses to:

Manage risk
Reduce costs
Manage suppliers
Communicate with customers
Improve workflows
Ensure compliance

With more than 25 modules that come standard, QT9 QMS excels at all of the processes you need for managing quality, including:

Document Control
Risk Management
Audit Management
Corrective Actions
Supplier Management
Employee Training
Inspections

QT9 QMS is a highly rated, easy-to-use quality management system based in the cloud for ultimate collaboration and connection. QT9 QMS offers unlimited scalability and traceability, full customer support, an ERP integration and Business Intelligence tool to help visualize and make informed decisions using real time data.

Modules for any business size

With multiple modules to choose from, there's solutions for nearly anyone.

A solution that scales with you

Whether you are a large corporation or a small start-up you can use as many modules as you want.

Cross-Platform Support

Whether you use Android, iOS or Windows, QT9 works from virtually any web browser.

“I love that QT9 is an all-encompassing suite of modules that covers every part of my QMS. We maintain an ISO9001:2015 certification, and this program will take the place of countless spreadsheets and emails.”

Sara Cutigni

APR Allen Plastics

“Easy to use and helps to organize information across our company. I like that you can easily load in tasks and reminders. Also, you can see who in the group still needs to complete something.”

Bill Ranous

Fulton

“QT9 QMS Software is a gamechanger for my organization. Implementation of the software was easy and quick. The customer support was unmatched. ”

Tara Buchanan

Torrent Photonics

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Cannabis Quality Management Software for Seed-to-Sale Excellence

Why cannabis businesses need a smarter QMS

Varying Regulations

Document Control

Traceability

Simplify cannabis regulatory compliance

Tailored QMS tools for cannabis operations

Document Control

Batch & Lot Traceability

CAPA Management

Audit Management

Change Management

Employee Training

Risk Management

Complaint Handling

Equipment Calibration

Built to support cannabis compliance

ISO 9001

FDA 21 CFR Part 11

Pre-validated QMS software

QT9 QMS is pre-validated for accelerated compliance.

Trusted by the world's leading cannabis companies

FAQ: Cannabis Industry

QT9™ QMS is flexible for your business.

Modules for any business size

A solution that scales with you

Cross-Platform Support

See what quality leaders say about QT9 QMS

Explore QMS resources

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