The problem
of project time went to manual data work.
How it works
Agents do the repetitive work. Your scientists make the calls.
run_014_export.csv
The original is kept, unchanged.
- Calibrators in rangeNo issue
- Controls in rangeNo issue
- Sample IDs match the manifestNo issue
- S-004 within assay rangeAnalyst decided
A qualified person decides every check.
Method
Results
run_014_export.csv, row 4
Conclusion
Every value links to its source.
Audit trail
IMMUTABLE- 09:41 signed, authorshipAnalyst
- 09:52 signed, reviewReviewer
- 10:06 signed, approvalQuality unit
Once signed, the report is locked.
The difference
less time on a first QC pass
less time to fill and review a report
Who it's for
We start where AI is hardest: regulated labs.
Compliance
Every number, traced to its source.
Sources are sealed when a report is signed, so you can prove nothing has changed.
Each framework below is a position Ordo maps to and documents, rather than a certification it holds.
Results
Row 4
Electronic signature
Approval · 2026-11-03 10:06:12 UTC · SHA-256 10cd49ee…bdd691b
GDPR
Hosted in the EU or the US, your choice, with the default AI route running inference only in the same one. No customer data is used to train models, at any point.
GMP & GLP
Records, review, and sign-off built to good manufacturing and good laboratory practice expectations.
21 CFR Part 11
Electronic records and signatures, with every signing and record-lifecycle event on an immutable audit trail.
EU GMP Annex 11
Validation support covering computerised systems used in GMP environments, set out in Ordo’s Customer Validation Pack, available under NDA.
Ordo is built for the confidentiality and record-keeping demands of regulated laboratories.
Mapping to 21 CFR Part 11 and EU GMP Annex 11 in Ordo's Customer Validation Pack, available under NDA on request. The pack includes a GMP compliance position, and a GLP compliance position mapped against the OECD GLP Principles, with 21 CFR Part 58 alongside for work that reaches FDA.
FAQ
Questions your QA lead will ask
Inference runs only in EU regions, or only in US regions for a deployment in the US. On the AI route Ordo runs by default, nothing is stored at the AI provider, not your files and records and not the requests we send, and the provider does not train on any of it. Scanned pages may also be read by a second provider in the same region, which keeps a page only if its abuse monitoring flags it.
Only people at your company, and the reach is deliberately wide: anyone you add can see your company's projects. Ordo enforces this in the database, not just the interface, so it holds however a request arrives. If you want an outside reviewer to see a report, you send it to them yourself: they get a link to that one report, which they can read, download and comment on, and nothing else.
A person does. The AI drafts. It proposes the steps, fills your template, and drafts a finding on each QC check. Every quality decision stays with a qualified person: on a QC check they pass or fail it, informed by what the AI drafted, and that decision is what goes on the audit trail. The AI's suggestion is never the record.
Signing is an electronic signature under 21 CFR Part 11. You re-authenticate, confirm with your second factor, and state what the signature means. You decide how many signatures a report needs and who can give each one. Where more than one is required, two different people sign, and every signature lands on the report's audit trail.
Nothing can change it. Once signed, the report is locked and the exact source files behind it are pinned, so nothing it rests on can shift underneath it. If something needs to change you create a new version. It is signed on its own chain and records where it came from, and the original is never altered.
Yes. Validation depends on your intended use, so it stays yours. What Ordo supplies is the package that makes it tractable: a validation plan, a functional specification and traceability matrix, an installation qualification protocol you execute and file, and URS and PQ templates to start from. Our team supports you through it.
Nothing. Ordo works from the files your instruments and systems already produce: CSV, Excel, PDFs, Word documents and images. You upload them, and Ordo keeps every original, so any number in a report traces back to the file it came from. There is no integration project to run first.
Ordo runs it, and there is nothing for you to install or maintain. You get your own deployment, and that is not reserved for large companies: it comes with a validation environment alongside your production one. Every release comes with a change notice classified by risk, so you take the release on validation first, re-check whatever the notice asks you to, and an owner at your company authorises the production upgrade once your QA team is satisfied. For your validation file, we supply the installation qualification protocol your system owner executes and records.
See what can run on its own in your lab.
Bring your own files, as they are. No integration project first.
Investor, or want to build this with us? Talk to us