Welcome to ProFlow Deviations

The Deviations Module is designed to manage, track, and resolve deviations effectively, ensuring compliance with GMP regulations, internal quality standards, and industry best practices. The system provides structured documentation, risk assessment, investigation, and resolution workflows to support quality assurance and continuous improvement.

Key Features

• Complete deviation lifecycle management with full traceability
• Automated notifications for key milestones and approvals
• Structured risk assessment to classify deviations based on severity and recurrence probability
• CAPA (Corrective and Preventive Actions) integration for long-term quality improvements
• Role-based access control ensuring proper authorization and compliance
• Comprehensive audit trails for regulatory compliance
• Customizable workflow steps to fit organizational processes

Process Overview

The Deviations Module follows a structured workflow to ensure every deviation is properly handled from detection to resolution:

1. Deviation Identification – Users log deviations with a unique tracking number, linking them to affected products, batches, or equipment.
2. Classification – Each deviation is categorized as Planned or Unplanned and assigned a severity level (Critical, Major, Minor).
3. Risk Assessment – Evaluates impact, probability, and detectability to determine risk level.
4. Investigation – Root cause analysis is conducted, with supporting documentation recorded.
5. Customer Notification – If applicable, contract manufacturing deviations require customer notification and tracking.
6. Corrective & Preventive Actions (CAPA) – When necessary, CAPAs are assigned, tracked, and resolved.
7. Approval Workflow – Investigations and CAPA resolutions are reviewed and approved by responsible stakeholders.
8. Final Closure – Deviations are closed only after all steps are completed, ensuring compliance and process improvements.

This structured approach ensures that every deviation is thoroughly reviewed, investigated, and resolved in compliance with GMP regulations. The module facilitates efficiency, transparency, and quality improvements across operations.