Welcome to the ProFlow CAPA

The ProFlow CAPA ensures the structured management of Corrective and Preventive Actions (CAPA), enabling organizations to identify, document, and resolve non-conformities efficiently. The module aligns with GMP, ISO, and regulatory compliance requirements, ensuring a proactive approach to quality assurance and continuous improvement.

Key Features

• Structured CAPA Lifecycle – From initiation to closure, every CAPA is systematically tracked.
• Role-Based Access Control – Ensures secure management of CAPA approvals and execution.
• GMP & ISO Compliance – Fully aligned with industry regulations for quality management.
• Risk-Based Decision Making – Supports impact assessments and effectiveness verification.
• Audit-Ready Documentation – Provides full traceability of actions and decisions.
• Automated Notifications – Keeps stakeholders informed at every stage of the CAPA process.

CAPA Process Overview

The CAPA process follows a structured workflow to ensure proper identification, execution, and verification of corrective and preventive actions.

1. CAPA Initiation – The need for CAPA is identified and documented.
2. Initial Review – The Head of Department (HOD) reviews and approves CAPA initiation.
3. Task Assignment – CAPA tasks are defined, assigned, and reviewed by QA.
4. Execution – Responsible persons implement corrective or preventive actions.
5. Effectiveness Review – If required, effectiveness checks are performed.
6. Final QA Approval – The CAPA is reviewed and officially closed by QA.

The module ensures that every CAPA is handled with full compliance, accountability, and transparency, preventing recurrence and strengthening quality management.