Sample to COA — paperless, traceable, audit-ready.
Built by life science experts to simplify laboratory information management.
“Our QC lab is finally paperless. Releases that took two days now happen the same morning samples are ready.”
Improved traceability & automation
Replace manual coordination with structured, configurable workflows — with a full audit trail on every action.
Confident compliance
Designed to support FDA 21 CFR Part 11, EU GMP Annex 11 and ISO 13485 — inspection-ready by default.
Data-driven oversight
Monitor activity, backlogs and compliance KPIs in real time so leadership has the visibility it needs.
Faster implementation
Go live in weeks — not quarters — with structured rollout, training and 24/7 support.
From day one — every step controlled.
Sample lifecycle
- Log samples with barcoded labels
- Route through testing per specification
- Capture results with second-person review
- Release with controlled e-signatures
Instrument integration
- Acquire results directly from instruments
- Reduce transcription errors to near zero
- Maintain raw data with audit trails
- Support 21 CFR Part 11 data integrity
Stability & specifications
- Manage stability protocols and pull dates
- Maintain specifications by product and method
- Trigger OOS / OOT investigations automatically
- Generate stability trend reports
COA generation
- Auto-generate COAs from approved results
- Apply customer-specific templates
- Sign and release with e-signature
- Distribute via portal or email
Everything LIMS ships with.
Electronic worksheets
Method-driven worksheets with calculations and limits.
Specification library
Version-controlled specs by product and method.
Stability scheduler
Automated pull, test and reporting for stability studies.
OOS / OOT workflow
Structured investigation aligned to FDA guidance.
Instrument interfaces
Integrate HPLC, GC, balances, dissolution and more.
COA engine
Templated COA generation, signature and distribution.
Designed to support the standards you’re audited against.
See LIMS on your own data.
Bring a real scenario from your operations — we’ll show you exactly how Laboratory Information Management handles it.