Core LIMS
QC signals and CAPA closure in the same system of record
Keep SPC and QC samples beside production work. When a result is out of specification, open OOS, deviation, and CAPA without leaving the laboratory record.
The problem
Why this matters on the bench
When QC charts live in one tool and CAPA lives in another, investigators lose time reconstructing context. Closure dates slip, and inspectors ask why the sample record and the quality record disagree.
Capabilities
How it works
QC, OOS & CAPA, step by step
Run QC with the work
QC samples and limits sit with methods and batches so analysts are not switching systems to see control status.
Signal OOS and OOT
Out-of-specification and out-of-trend events can open investigations from the result that triggered them.
Investigate with context
Deviation records carry sample, method, instrument, and analyst context instead of a pasted ticket number.
Close CAPA with evidence
Actions, effectiveness checks, and closure are attributable and remain linked to the originating record.
Regulatory relevance
Compliance, precisely stated
OOS investigation and CAPA are expected elements of GMP quality systems and are relevant to ISO/IEC 17025 nonconforming-work control. Aureon is designed to support those workflows; it does not replace your quality manual.
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
Yes. Investigations can start from the failing or suspect result and remain linked to that record.
See qc, oos & capa against your SOPs
Book a demo or talk to sales about scope and validation support.