Reports
Ordo fills your own template while the study runs and links every number back to the file it came from. Nothing is retyped, and nothing is left to the end.
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Slot · Study IDBIO-2026-017
The AI workspace
for regulated science
- GDPR
- GMP & GLP
- 21 CFR Part 11
- EU GMP Annex 11
Every lab. Every regime.
Ordo runs the checks your regime asks about and leaves the trail to match, from raw export to signed report.
GLP · 21 CFR Part 58 · OECD
Bioanalytical labs
CROs and assay-kit makers running immunoassays and LC-MS/MS under GLP.
From raw run to signed report.
Drop in the raw instrument export. Ordo reads it as it is, runs your checks, and hands back a report your reviewer can sign.
Traceability and sign-off
Every value links back to its source file, and every signing and record-lifecycle event sits on an immutable audit trail.
IMMUTABLE
value ← Study_Diary.pdf, p.4source
10:06 · approvedQuality unit
Data agent
Pull files from instruments, LIMS, and spreadsheets, then say what you need in plain words. Ordo builds the steps and runs them safely.
3 CONNECTED
InstrumentsRaw export
LIMSConnected
QC automation
Ordo checks the data and the draft against your SOP the same way every time, so your team only reviews what failed.
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FLAGGED
Customer Report writes dates as “July 2025”; Sample Manifest writes them as “2025-07”. Same dates, different formats.
Built for the most rigorous
standards in regulated science.
Ordo is built for the confidentiality and record-keeping demands of regulated laboratories. Each framework below is a position Ordo maps to and documents, rather than a certification it holds.
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.
Frequently Asked Questions
Would rather talk it through? Talk to us
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. The provider does not train on any of 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.
Explore the automation opportunity in your lab.
We map how your lab works today and show what can run on its own.