Automated Deviation Management Software
Track temporary planned deviations by product and process with QT9 QMS.
Easily Track Deviations
Log, tag and monitor nonconformances in real time.
Root Cause Analysis
Identify causes faster with guided workflows.
Comply with Regulations
Ensure deviation processes meet FDA, ISO and GMP standards.
Instant Notifications
Alert teams immediately to new or unresolved deviations.
Deviation Records
Access all deviation data from one secure platform.
Speed Up CAPA Process
Link deviations directly to corrective actions.
What is Deviations Software?
Deviation management software helps organizations systematically identify, document, investigate and resolve nonconformances or deviations from established processes. It is a critical part of quality management systems (QMS) used across industries like manufacturing, pharmaceuticals and healthcare to maintain compliance with standards such as ISO 9001, FDA, and GMP.
QT9’s Deviations Software streamlines how companies handle deviations by automating deviation logging, root cause analysis, and corrective action workflows. Fully integrated within the QT9 QMS platform, it ensures efficient deviation tracking, timely notifications and comprehensive reporting to support regulatory compliance and continuous quality improvement.
Interactive Video Demo
QT9 QMS Deviations Demo
All-in-One Deviation Management System
Seamlessly link deviations to products and processes with QT9 QMS.
Manage Approvals
Assign approver/s and approve, reject or verify deviations.
Email Alerts
Send users email alerts and reminders based on your settings.
Real-Time Reporting
Track your deviations by any field. Create charts and export reports to Excel.
Assign Tasks
Assign unlimited tasks to responsible parties with email alerts.
Electronic Signatures
Capture signatures electronically at all approval levels.
User-Defined Fields
Create unlimited custom fields for tracking company-specific information.
Attach Related Files
Track certificates of analysis or compliance with unlimited file attachments on inspection records.
Date Ranges
Set up date ranges for deviations and receive email alerts on the end date.
Automated Notifications
Send automated email notifications when deviations end.
Link Risk Assessments
Link deviations to risk assessments for risk analysis.
Create Corrective Actions
Link deviations to corrective actions for business improvement.
ECR Escalation
Escalate deviations to an engineering change request for permanent resolution.
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FAQ: Deviation Management
The definition of a deviation varies slightly depending on the industry, but in general, a deviation is any departure from an approved process, procedure, specification or established standard. FDA current good manufacturing practice (cGMP) defines a deviation as any result that falls outside the expected range or fails to fulfill a specific requirement.
Deviation management is the systematic process undertaken to identify, document, investigate and address any unplanned events that deviate from approved processes during manufacturing, distribution, storage or testing. The goal of having a method for managing deviations is to avoid larger problems by promptly identifying, investigating and resolving any deviations.
Deviation management guidelines will vary depending on the guiding authority. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) require companies to maintain documented and approved procedures for controlling deviations. These procedures should use a systematic approach to recording, investigating and correcting deviations to prevent recurrence.
A planned deviation is one that is pre-approved and intentional. For example, a planned deviation would occur if a manufacturer were testing process improvements or the use of an alternative material.
An unplanned deviation is an unexpected departure from approved procedures, such as an equipment failure, material contamination or unforeseen manufacturing disruption.
When an unplanned deviation occurs, the corrective and preventive action (CAPA) process is used to evaluate, investigate and resolve the cause of the deviation. Preventive actions are put in place to ensure the deviation does not reoccur.
QT9 QMS has 25-plus interconnected modules that come standard, including Deviation Management, which seamlessly integrates with other key applications, such as CAPA management, risk management, customer feedback, and supplier management. Its cloud-based platform allows you to keep track of deviations and synchronize records with anyone, anywhere.
QT9’s QMS software is a highly rated, affordable, easy-to-use quality management system that excels at all of the processes that go into providing high-quality goods and services that are FDA and ISO compliant.
With QT9 QMS you get unlimited scalability and traceability at a great price, so you can bring quality products and services to market in the most efficient way.
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