Change control system — available anytime, any place.

The Change Control Module in QT9™ QMS makes it simple to keep track of change control processes and synchronize records with anyone, anywhere.

Automate change control

Reduce staff time by eliminating manual change control processes.

Improve transparency

Track your impact assessments, change planning & implementation plan.

Connect & collaborate online

Utilize tasks, approval processes and even link to documents.

Manage change control

Manage inclusion of key personnel, processes and departments.

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Free up time with change control tools built-in to QT9™ QMS.

QT9's change control system seamlessly links to document control, deviations, and corrective actions to ensure all proper actions have been taken.

Link Processes

Link change control records to processes & departments.

Document Control

Full integration to document control.

Real-Time Reporting

Assist with data mining & trend analysis using charts & graphs.

Manage Approvals

Assign approver/s and approve, reject or verify change control records.

Improve Participation

Use Change Control tasks to get more people involved on any change control project.

User-Defined Fields

Create unlimited user-defined fields for tracking your company-specific information.

Email Alerts

QT9 QMS sends users email alerts and reminders.

Attach Related Files

Attach unlimited files to any change control record.

Change Control History

See the history of change control records.

Explore 25+ Modules Included

Frequently Asked Questions: Change Control

What is change control?

Change control is a process used to manage changes to a product, organizational structure, process, equipment, input or methodology so that changes are introduced and controlled in a coordinated manner. The goals of change control procedures are to ensure thorough evaluation and documentation of the change’s necessity, impacts and implementation so that there is minimal disruption to services and a cost-effective use of resources.

Why is change control important to quality management?

The goal of a quality management system is to ensure the ongoing quality and safety of your products and services. Any changes that occur in the process of creating these products and services must be thoroughly evaluated and documented to ensure their integrity and to meet regulatory requirements that hold organizations to these standards.

What regulations require implementing change control?

Both the International Organization for Standardization (ISO), GMP, and the U.S. Food and Drug Administration (FDA) discuss methods for managing change control in their regulatory requirements.


ISO 9001 and ISO 13485 require an organization to have plans in place to manage the change process, review the consequences of unintended changes and prevent or mitigate any adverse effects. GMP guidelines state, “Significant amendments to the manufacturing process, including any change in equipment or materials, which may affect product quality and/or the reproducibility of the process should be validated.”


FDA 21 CFR Parts 210, 211 and 820 all require manufacturers to establish and maintain procedures for the identification, documentation, validation, verification, review, and approval of design and manufacturing changes. In addition, any changes to documents require review and approval by a qualified monitor, and communication of changes to stakeholders in a timely manner.

How is change control different from project management?

While the goals of change control and project management differ, the basic approach to each is very similar – initiate, analyze, plan, execute, close. Change control, however, looks to manage the process of change and predict how it may affect already established systems. Project management is tasked with ushering a team or product from Point A to Point B until the project’s goal is completed.

How can QT9 QMS help me with change control?

QT9 incorporates a robust change control application into its eQMS. The module is able to integrate with related applications, such as corrective actions, deviations, and document control.


QT9 QMS is a total quality solution available at an accessible price point, with 25-plus standard modules that help simplify and centralize quality and compliance. Plus QT9 offers full customer support, an ERP integration and a Business Intelligence tool to help visualize and make informed decisions in real time.


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Get a real-time view of your change control records.

Sign in online anytime, anywhere to get a real-time view of your change control records.

Built-In Dashboard

Quickly view change control records from the QT9 dashboard, and easily personalize the view.

FDA & ISO Compliant

The QT9™ QMS change control module keeps you compliant with all FDA and ISO requirements.


Manage change control records from your desktop, tablet or mobile device from virtually anywhere.

QT9™ QMS is flexible for your business.

QT9 lets you choose modules based on what's best for your organization.

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.

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