AI report generation for GMP and GLP labs

Your template, filled from your raw data

Upload the report template you already use, as a Word document, and the files behind the work: instrument exports, CSV and Excel files, PDFs and Word documents. Ordo fills the template from those files while the work runs, so the report is not left to the end and nothing is retyped.

Every file you upload is kept exactly as it arrived, so the raw data is always there behind the report.

Every value traced to its source

When Ordo drafts a value from one of your files, it records the file and the passage the value came from, and it refuses a quote the file does not contain. A table filled from a file records which file. A value someone types or corrects by hand is marked and logged, and never shown as sourced.

Signing the report locks every source file behind it: none can be deleted, and you can show that none has changed since. So when an inspector points at a number in a signed report, you can show the raw file it came from, for as long as the record is kept.

QC checks from your SOP

Your SOP's QC checks become a checklist, written once or pulled out of the SOP document itself. Ordo runs them against the data and the draft, for things like missing values, outliers, drift and control failures, and drafts a finding for each check.

A named reviewer passes or fails every check, and that decision is what goes on the audit trail, not the finding the AI drafted. Ordo checks your work against your SOPs. It does not write them.

Review and electronic signature

A report is signed position by position under a signature policy you set, such as a review and then an approval. Each signature is an electronic signature under 21 CFR Part 11: the signer re-enters their password and a second factor and states what the signature means. The signatures that complete a report always come from different people, so a policy that asks for a second-person review gets a second person.

The final signature locks the report. A change after that is a new version, signed on its own chain and pointing back to the original, which is never altered. Every signature and every record-lifecycle event is written to an audit trail the application cannot alter.

The AI drafts. A person decides.

Ordo uses a large language model to draft report values, QC findings and the code that processes your data. Whether a drafted value is right is for your reviewer to decide. A named person reviews, accepts and signs every regulated output, and those human acts are what your validation qualifies.

Validation documentation

You validate Ordo for your own intended use. Ordo Labs supplies the Customer Validation Pack that makes that a job you can finish: a validation plan, a functional specification and traceability matrix, an installation qualification protocol, and a GMP and a GLP compliance position. It is shared under NDA.