CAPA & Deviation Manager
CAPA & Deviation Manager is a Dolibarr module for managing quality deviations, investigations, root cause analysis, corrective and preventive actions, effectiveness checks and audit trails.
The module provides a structured workflow from deviation creation through investigation and CAPA implementation to effectiveness verification and final closure.
It is designed for laboratories, pharmaceutical environments, manufacturing, quality departments and other organizations that need a traceable deviation and CAPA workflow inside Dolibarr.
Main features
- Deviation creation and tracking
- Automatic deviation reference numbering
- Severity management: Minor, Major and Critical
- Workflow statuses: Open, Investigation, CAPA, Effectiveness and Closed
- Root cause investigation
- Root cause categories
- 5 Why root cause analysis
- Corrective actions
- Preventive actions
- Effectiveness check result
- Effectiveness status management
- Controlled deviation closure
- Due date and owner management
- Product, lot/batch, supplier and equipment reference fields
- File attachments and supporting evidence
- Complete audit trail
- Professional PDF reports
- Responsive desktop and mobile interface
- Integration with LabQC Pro
- Integration with Calibration & Equipment Pro
- Duplicate CAPA prevention for integrated source records
Dashboard
The dashboard provides a quick overview of deviations by workflow status and shows the most recent deviation records.
Users can immediately see how many deviations are Open, under Investigation, in CAPA, waiting for Effectiveness verification or already Closed.
Deviation management
The deviation list provides filtering by reference, title, severity and status.
Each deviation includes its reference, title, severity, current workflow status, due date and opening date.
Investigation and root cause analysis
Each deviation can contain a structured investigation with a root cause category and detailed investigation text.
The module also includes a dedicated 5 Why analysis section. Up to five sequential Why questions can be recorded to help document the investigation path and identify the underlying root cause.
Corrective and preventive actions can then be defined directly in the same deviation record.
CAPA workflow
The standard workflow is:
Open → Investigation → CAPA → Effectiveness → Closed
During the CAPA phase, users can document corrective and preventive actions.
During the Effectiveness phase, the effectiveness check result and effectiveness status are recorded.
A deviation cannot be closed until the effectiveness check result has been completed and an effectiveness status has been selected.
This helps maintain a controlled and traceable closure process.
Audit trail
CAPA & Deviation Manager records important actions in the audit trail.
The audit trail includes deviation creation, field updates, status changes, effectiveness status changes, attachment uploads and attachment deletions.
Each audit entry includes the date and time, event type, details and the user who performed the action.
Attachments
Supporting evidence can be attached directly to a deviation.
Examples include investigation documents, laboratory reports, screenshots, calibration evidence and other relevant files.
Attachments can be downloaded or deleted, and attachment events are recorded in the audit trail.
PDF reports
A professional PDF report can be generated for each deviation.
The report includes deviation information, investigation data, 5 Why analysis, CAPA actions, effectiveness information and the complete audit trail.
Mobile interface
The module is responsive and can be used from smartphones and tablets.
Deviation information, investigation data, 5 Why analysis, CAPA actions, attachments and audit trail remain accessible on smaller screens.
LabQC Pro integration
CAPA & Deviation Manager integrates with LabQC Pro.
A finalized FAIL / OOS QC test can create a CAPA deviation directly from the QC test page.
The CAPA form is automatically prefilled with available information such as:
QC test reference, product, lot / batch, specification, department, severity and source record.
After the deviation is created, LabQC Pro displays a direct link to the existing CAPA deviation instead of allowing a duplicate deviation to be created.
Calibration & Equipment Pro integration
The module also integrates with Calibration & Equipment Pro.
A calibration with result Failed or Conditional can generate a CAPA deviation.
Available calibration data is automatically transferred to the deviation, including equipment code, calibration date, calibration provider, certificate number, result and source record.
After creation, the calibration record links directly to the existing CAPA deviation.
Requirements
Dolibarr: 23.x or 24.x
PHP: 7.4 or later
Module version: 1.2.2
Installation
Copy the module folder into:
htdocs/custom/capadeviationmanager/
Then open:
Home → Setup → Modules/Applications
Find CAPA & Deviation Manager and activate the module.
After activation, the CAPA menu becomes available in Dolibarr.
Upgrade
To upgrade from a previous version, replace the existing module files with the new version and reactivate the module if necessary.
It is recommended to create a backup before upgrading production systems.
Support
Support contact:
support@panciucsoft.com
For bug reports, installation questions or integration support, include the Dolibarr version, PHP version, module version and a description of the issue.
License
CAPA & Deviation Manager is distributed as a Dolibarr external module under the license included in the module package.