CAPA Initiation — ParanoiaIQ

ParanoiaIQ | CAPA Initiation ISO 13485 §8.5.2 · 21 CFR Part 820

Open CAPA

Describe what happened. We'll fill in the details.

What happened? (plain language)

Include: what product, what part failed, how it failed, where it was found, when, and what triggered this CAPA. Don't worry about format.

Extracted Fields

What Broke?

Product Name *

What part or component failed? *

How did it fail? *

Lot / Serial (if known)

Where & When?

Where was it found? *

Date First Observed *

Units Affected *

Complaints / Reports Filed

Impact & Source

Patient Outcome *

What triggered this CAPA? *

Audit Finding Class

Risk Flags (check all that apply)

Sterile product — sterility assurance requirements apply Vulnerable patient population — pediatric, neonatal, or immunocompromised Life-sustaining / life-supporting device — ventilator, pump, cardiac monitor, dialysis

These affect priority tier and field action risk. Sterility and life-sustaining failures are never Minor.

Which population? (ICH E11 / FDA subgroups)

CAPA Record

CAPA ID (optional)

Date Opened *

Authentication

API Key *

📋

No CAPA opened yet

Describe the failure in the panel on the left — a sentence or two is enough — then click Open CAPA.

Building CAPA...

20–40 seconds · 7 tools

Problem Statement (IS / IS NOT)

Classification & Priority

Scope Boundary

Containment Actions

Field Action Risk (21 CFR 806)

Deadline Calculation

Investigation Agenda