Quality expansion
Certificates of analysis from approved data — not a side spreadsheet
Generate CoA and release documentation from the same controlled results, specifications, and signatures that QA already trusts.
The problem
Why this matters on the bench
When CoA is assembled in a desktop file, version drift is inevitable. The LIMS says one thing; the PDF says another. Inspectors notice.
Capabilities
How it works
Reporting & CoA, step by step
Use approved results only
Reporting draws from reviewed, in-specification (or dispositioned) results — not a parallel workbook.
Bind specifications
Method and spec versions used at test time appear on the report so limits are not rewritten by hand.
Apply release meaning
Signatures and release status travel with the document package.
Issue a controlled output
Issued CoAs are records. Revisions are new issues, not silent overwrites.
Regulatory relevance
Compliance, precisely stated
Release documentation is part of the regulated record. Aureon is designed so CoA content is traceable to approved results and signatures. Template qualification is part of customer 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.
Questions
What evaluators ask
Templates are configured during implementation. We do not claim every historical layout is available without design work.
See reporting & coa against your SOPs
Book a demo or talk to sales about scope and validation support.