Workflow for CAPA

The MedQdoc CAPA workflow provides a structured, compliant, and fully traceable process to manage corrective and preventive actions throughout their lifecycle.

The following stages are part of the MedQdoc CAPA lifecycle, ensuring traceability, accountability, and visibility at every step:

• Information — CAPA request is logged and evaluated for scope and priority.
• Investigation — Data is reviewed, and a root-cause analysis is conducted (e.g., 5-Why, Fishbone Diagram).
• Action Planning — Corrective and/or preventive actions are defined; responsible owners and due dates are assigned.
• Implementation — Actions are executed, supporting evidence is attached, and related documents are updated.
• Effectiveness Verification — Outcomes are measured and validated to confirm that actions were effective.
• Closure — CAPA is reviewed, approved, and formally closed. All records are securely archived for audit purposes.

Key Benefits of CAPA in MedQdoc

• Integrated traceability across NCs, Complaints, Supplier issues, Changes, and Risk files.
• Audit-ready records aligned with ISO 13485 and FDA 21 CFR 820/QMSR expectations.
• Structured lifecycle with role-based reviews and approvals for strong governance.
• Action tracking, reminders, and effectiveness verification to ensure sustained results.

Regulatory Framework

MedQdoc CAPA supports regulatory expectations in both ISO and FDA frameworks:

• ISO 13485:2016 — Clause 8.5 (Corrective & Preventive Action)
  Requires documented methods to investigate nonconformities, determine root cause, plan and implement actions, assess effectiveness, and update risks and documentation where necessary.
• FDA 21 CFR Part 820.100 / QMSR
  Requires procedures for analyzing quality data, investigating causes of nonconformities, identifying actions, verifying/validating effectiveness, implementing and recording changes, communicating results, and disseminating information to relevant functions.

When to Use CAPA

• Significant recurring issues or trends (e.g., repeated NCs, complaints, supplier issues).
• Systemic process gaps revealed during audits, monitoring, or data analysis.
• Post-market information indicating product or process risk that requires systemic action.

Want to explore how Change Management works in MedQdoc?
See detailed examples of automated workflows and best-practice forms below.