What Carapace does.

Controlled documents, signed properly.

Draft, review, approve, effective. One effective version at a time, and the earlier version is superseded on release.

• Electronic signatures. Each one is bound to a meaning, such as review or approval, and needs your password. If the content changes after signing, the signature is void.
• Deviations. Record severity, investigate, send to QA review. Closing needs QA and a signature. Major and critical deviations need a CAPA first.
• CAPA. Actions with owners and due dates. QA checks effectiveness, then signs to close.
• Change control. Raise a change, assess its impact, route it for approval, track the tasks and close it with evidence. Larger changes need two different approvers.
• Training. People are assigned the effective version and sign to confirm they have read and understood it.
• Controlled copies and access review. Issue numbered PDF copies of effective documents and withdraw them. Review who has access on a schedule, and sign the review.

A lab notebook that can be witnessed.

Numbered entries linked to your documents, deviations and batches. The author signs, a different person witnesses, and later corrections are addenda, never edits.

• Numbered entries. Each experiment is a sequence of entries, in order, with the time they were written.
• Signed, then witnessed. The author signs. A different person witnesses. The author cannot witness their own work.
• Addenda, not edits. After signing, a correction is added alongside the original, and both are kept.
• Linked to the rest. Point an entry at the SOP it followed, the deviation it raised or the batch it relates to.

Run batches step by step.

Build a batch template and approve it. Run batches against it, step by step, with limits. A second person releases, and the signature covers every recorded step.

• Approved templates. A template is approved before anyone can run a batch from it.
• Limits on steps. Each step can carry limits for what is recorded.
• Materials used. Add released lots to the batch as you go. Each use is recorded once, with the quantity.
• Second-person release. The person who ran the batch does not release it.

Know what you buy, and where it went.

Qualify suppliers, raise corrective action requests, receive each delivery into quarantine, release it, and see every batch it went into.

• Supplier qualification. Proposed, assessed, then decided by QA with a review date. The person who proposed a supplier cannot approve it.
• Supplier corrective actions (SCARs). Raise one against a supplier and track it to closure. The person who raised it does not close it.
• Lots in quarantine. Each delivery is a lot. QA or Admin releases or rejects it. The person who received it cannot release it, and an expired lot cannot be released.
• Supplier gate. A lot from a supplier that is not approved or conditional cannot be released.
• Traceability. From a lot, see every batch it went into. From a batch, see its lots. Use cannot exceed what is left.

Equipment that is in date, or out of service.

A register of the equipment you rely on, with calibration records that are written once and never changed.

• Calibration records. Date, pass or fail, who did it, certificate reference, notes. Nothing is edited afterwards.
• A fail takes it out of service. Straight away, with notes on what failed.
• Independent return to service. QA or Admin, with an in-date pass, and not the person who recorded the calibration.
• At a glance. In service, due soon, overdue, out of service or retired. Retiring is permanent and the records stay.

A record you can show an inspector.

Who did what, and when. Each entry is chained to the one before, so a change after the fact shows up. The rules that matter are held by the database, not just the screens.

• Tamper-evident. Each entry is hash-chained to the one before it. Verify the chain on demand.
• Checkable elsewhere. Export the audit trail and verify it on your own computer, without trusting us.
• Segregation of duties. Enforced in the database. The author of a record cannot approve it.
• Archived, not deleted. Records are archived rather than removed, so history stays whole.

An assistant that shows its working.

Ask questions of your SOPs and records and see where each answer came from. Cara drafts; people decide.

• Sources on every answer. Each statement points to the record it came from, so you can read it before you act.
• Drafts for review. On a deviation she can suggest a root cause or a CAPA. Nothing is saved until a person edits and applies it.
• Never decides. She does not sign, approve, release or close anything, and works with the access of the person asking.
• Under your control. An administrator can switch her off for the whole organisation.

Your data stays yours.

Take everything out whenever you like, or let your own tools read it with a key you control.

curl -H "Authorization: Bearer cpk_…" \
  ".../v1/deviations?limit=10"

• Full export. Every record as CSV files, with the audit trail and a small script that checks the chain.
• Read-only API. An administrator creates keys that read records, the audit trail, or both. Each key expires within two years, can be revoked, and is limited to 60 requests a minute.
• Nothing written back. The API cannot change anything.

curl -H "Authorization: Bearer cpk_…" \
  ".../v1/deviations?limit=10"