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How case text is handled

This page describes the controls that are actually in the workspace. It does not claim 21 CFR Part 11, GAMP 5, SOC 2, ISO 27001, or a HIPAA business associate agreement.

Data handling

You paste a narrative or upload a PDF, Word file, text, email, CSV, or image. The file is parsed in your browser. The file itself is not uploaded. The extracted text is sent to the AE Connect API when you create a case or run an assessment.

When an Anthropic API key is configured, that text is sent to Anthropic to produce the draft. If the key is not set, the server returns a deterministic mock and does not call the model. We do not sell personal information, and we do not use case narratives to train a public model of our own. The Privacy Policy is a draft and names the other processors (Netlify, the database host, Stripe, Google Fonts). A street address is not published.

Audit trail

Each field decision is stored on the signed-in account: what the draft said, whether you accepted it or overrode it, and the value you kept. Cases are scoped to that account. This site has no e-signature step. Sign-off, if your quality system requires one, belongs in the safety database your process names.

MedDRA

The draft suggests a MedDRA preferred term and system organ class, with a short reason. A reviewer accepts or overrides it. AE Connect does not grant a MedDRA license, and the suggestion is not a coding certificate. The MedDRA term in Oracle Argus, ArisGlobal LifeSphere, or Veeva Vault Safety is the one your MedDRA subscription and your coder stand behind. AE Connect integrates with those safety databases. They remain the system of record.

Trial workspace

A company email starts a 14-day sandbox with unlimited cases. That sandbox is a product workspace, not a validated computerized-system environment, and not an environment we claim is qualified. AE Connect can feed your safety database or be the safety database for the full ICSR and the E2B(R3) file.

Questions: info@qfsnow.com.