Ordo Labs
Develops Ordo, an AI workspace for regulated laboratories that drafts reports, runs SOP-defined QC checks, and traces reported values to source data.
Past recognitions
About Ordo Labs
Ordo Labs is bringing AI into regulated labs. In paid pilots with labs in the US and Europe, Ordo cut post-analysis work by 90%+. CROs and CDMOs are a $314.8B industry, but they can't rely on generic AI tools, because every result must be traceable, every system validated, and every change QA-approved. Ordo is the AI-native OS for regulated labs: each lab gets its own deployment built to be validated, every output links back to its source data, and scientists and QA sign off on every result. Every workflow on Ordo inherits these controls. Live today: data analysis, quality review and reporting. We're advised by laboratory executives and have interviewed 100+ scientists. Our goal is to make regulated labs AI-native, so science can move at the speed of AI. Run a CRO or CDMO? Email us at founders@ordolabs.ai.
Products
AI workspace for regulated labs that drafts reports from raw files, runs SOP-based QC checks, and supports human review, source traceability, and electronic signatures.
Security and compliance
As reported by Ordo Labs. Ask for audit reports before you buy.
- Good Manufacturing Practice (GMP)Certified
- Good Laboratory Practice (GLP)Certified
- 21 CFR Part 11Certified
- EU GMP Annex 11Certified
- OECD GLP PrinciplesCertified
- 21 CFR Part 58Certified
- Report values link back to their original source data.
- Electronic signatures require re-authentication, a second factor, and a stated signature meaning.
- Signing and record-lifecycle events are recorded in an immutable audit trail.
- Signed reports and their source files are locked; changes require a separately signed new version that preserves the original.
- Company-level data access is enforced in the database; external reviewer links are limited to a single report.
- Qualified people retain quality decisions; AI suggestions are not the record.
- Customer data is not used to train models. The default AI route does not retain files, records, or requests; secondary scanned-page processing may retain pages flagged by abuse monitoring.
- Each customer receives its own deployment with separate validation and production environments.
- Releases include risk-classified change notices and require customer authorization before production upgrades.
- Customer validation support includes a validation plan, functional specification, traceability matrix, installation qualification protocol, and URS and PQ templates.
Is this your company?
Claim the profile to keep facts current, answer buyers and submit evidence for the next ranking review.
Claim Ordo Labs