Plumely

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Deviation & CAPA Tracker

Mobile-first deviation logging and CAPA tracking built for the shop floor, not just the QA office.

The problem it solves

Deviations get noticed on the floor but written up later from memory in the QA office, and CAPA closure often has no real accountability step — just a status flipped to "closed" by whoever remembered to do it.

How it works

  1. 1Log a deviation against the batch it affects, as close to the moment it happened as possible.
  2. 2Work through root-cause analysis, then open a CAPA with its own tracked tasks.
  3. 3Close the CAPA with a real electronic signature — password re-authentication, a captured meaning (e.g. "reviewed and approved"), and a record hash binding the signature to that exact version of the record.

Who it’s for

Production managers and QA managers on the shop floor and in the quality office.

Is the e-signature step actually enforced, or just a checkbox?

It's enforced server-side: closing a deviation requires re-entering your password, capturing what the signature means, and binding it to a hash of the record at that moment. The underlying signature record is also append-only — it can't be edited after the fact, including by an administrator.

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