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Quality system for small GxP teams

Quality records that stand up to inspection.

Carapace keeps your documents, signatures, deviations, batch records, notebooks, suppliers and equipment in one place, and records who did what and when.

Supports 21 CFR Part 11 and EU GMP Annex 11 requirements.
Audit-trailed. Electronic signatures.

The problem

Records sit in shared drives, spreadsheets and inboxes, and nobody is sure which version is current.

A signature on a PDF does not show what it covered, who could have changed the page afterwards, or when.

Enterprise quality systems are built for enterprise teams. A team of ten should not need a team to run it.

What it covers

One system for the whole quality record.

Full overview →

In use

Deviations
Example

Needs QA

1

Actions open

2

Ready to close

1

DEV-2026-0004 Temperature excursion, cold room 2QA review
DEV-2026-0003 Door seal worn throughCAPA open
DEV-2026-0001 Missing field at initiationClosed

DEV-2026-0004 · Major deviations need a CAPA before QA can close

Ask Cara
Example

Ask across your SOPs and records

What do we do when a cold room goes out of range?

Move product to the backup unit, record the excursion as a deviation and tell QA within the shift. A similar event last month was handled the same way.

Sources: SOP-2026-0007 v2 · DEV-2026-0003

Example data. Cara reads and drafts. A person decides.

The record

Who did what, and when.

Every change to a controlled record is written to an audit trail. Each entry is chained to the one before it, so a change after the fact shows up. Check the chain in the app, or export it and check it on your own computer.

Signatures carry a stated meaning and your password. If the content changes after signing, the signature is void.
Audit trail
Example
10:42 document.approveda41f…c92e
10:51 document.released5d02…e8a7
11:06 capa.verified91cc…4b60

Each entry stores the hash of the one before it.

Who it's for

Built for teams of 5 to 100.

  • Biotech
  • Cell and gene therapy
  • CDMOs
  • Medtech

Carapace supports your validation effort. It does not replace it. You remain responsible for validating the system for your intended use.

Questions

Does Carapace replace our validation?
No. Carapace is built to support 21 CFR Part 11 and EU GMP Annex 11 requirements, and it supports your validation effort. You remain responsible for validating it for your intended use.
Where do the rules live?
In the database, not just the screens. The author of a record cannot approve it, a signature is void if the content changes afterwards, and an audit entry cannot be edited or removed. Hiding a button is never the only protection.
Can we get our data out?
Yes, at any time. An administrator can download every record as CSV files, with the audit trail and a small script that checks the audit chain on your own computer. A read-only API is also available, with keys you create, scope and revoke.
What does Cara do?
Cara answers questions from your own SOPs and records and shows the source of every answer. She can draft a root cause or a CAPA for a person to review. She never signs, approves, releases or closes anything, and an administrator can switch her off.
How do we start?
Book a demo. Carapace is not a self-service sign-up: we set up your organisation, then you invite your team and give each person a role.

Curious? Let's talk.

A short call about how your team keeps its quality records today. No obligation.

Book a demo