From first draft to inspection.

Set up your team

We set up your organisation. You invite your people by email and give each one a role: Admin, QA, Author, Reviewer or Read-only. What someone can do follows from their role.

Carapace is invite-only. Nobody signs up on their own.

Write and control documents

Draft an SOP, send it for review, approve it, release it. Only one version is effective at a time, and the earlier one is superseded when the new one is released.

Assign the effective version to your people. They sign to confirm they have read and understood it.

Sign with a meaning

Every signature says what it means, such as review or approval, and needs the signer's password. The person who authored a record cannot approve it, and a signature is void if the content changes afterwards.

Record what goes wrong, and fix it

Log a deviation, investigate it, and send it to QA. Major and critical deviations need a CAPA before they can close. QA checks that the fix worked, then signs to close.

Control change

Raise a change, assess its impact, route it for approval and track the tasks. Larger changes need two different approvers. Close it with evidence.

Run the work

Record experiments in the lab notebook: the author signs and someone else witnesses. Run batches against an approved template, step by step, with limits, and have a second person release.

Corrections after signing are added as addenda. The original stays.

Control what goes in

Qualify suppliers and track corrective actions against them. Receive each delivery into quarantine; QA releases or rejects it. Add released lots to batches, and see every batch a lot went into. Keep equipment calibrated, or take it out of service.

Show it, and take it with you

Every change is written to a hash-chained audit trail that you can verify in the app or on your own computer. Export everything, or let your own tools read it through a read-only API.

Ask Cara questions of your SOPs and records. She shows her sources, and she never decides.