CAPA record

Supplement Appendix D

Corrective and preventive action record for REJECT, ALARM, or escalated CLINICAL REVIEW events. Includes root cause analysis, corrective action plan, and regulatory notification assessment.

Device information

Common header

Device name *

Include version number

Intended use *

Reference IEC 62304 or IFU documentation

Author name *

Author role *

Date *

Organisation *

Event identification

Supplementary Appendix D

Iteration number *

Decision trigger *

Alarm conditions triggered

Trigger metrics and values *

Event date *

Root cause analysis

Supplementary Appendix D

Root cause category *

Root cause description *

Supporting evidence

Corrective action plan

Supplementary Appendix D

Corrective action description *

Responsible person *

Target completion date *

Verification method *

Preventive action

Regulatory notification assessment

Supplementary Appendix D

Regulatory notification required *

Notification rationale

Notification date (if applicable)

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