Core LIMS
Inspection-oriented history, not a hidden log file
Aureon LIMS is designed around attributable, contemporaneous records: an immutable audit trail, e-signatures bound to meaning, and exports QA can walk through with an inspector.
The problem
Why this matters on the bench
Many systems record that something changed. Fewer make it practical to show who did what, why, and whether the signature meaning still holds. That gap appears during inspection, not during a demo.
Capabilities
How it works
Audit trail & compliance, step by step
Record every regulated change
Create, update, review, and status events are attributable. Meaning is captured with the action, not reconstructed later.
Keep history immutable
Audit records are append-only. Corrections are new events. Regulated data is not hard-deleted.
Bind e-signatures
Signatures carry role, meaning, and timestamp so review and approval are first-class records.
Export for inspection
Filter and export history for a sample, batch, method, or date range in a form QA can review.
Regulatory relevance
Compliance, precisely stated
Aureon LIMS is designed to support 21 CFR Part 11 expectations for electronic records and signatures, and ISO/IEC 17025 record-control practices. It is not FDA-approved or “Part 11 certified.” Customers remain responsible for validation.
Aureon LIMS is designed to support 21 CFR Part 11 and ISO/IEC 17025 workflows. It is not FDA-approved or “Part 11 certified.” Customers remain responsible for system validation, SOP alignment, and regulatory interpretation in their own quality system.
Related modules
Questions
What evaluators ask
No product is “Part 11 certified” in the sense some vendors imply. Aureon is designed to support Part 11 workflows. Your validation demonstrates fitness for intended use.
See audit trail & compliance against your SOPs
Book a demo or talk to sales about scope and validation support.