Compliance
QA buyers need precise language. Aureon LIMS is built for attributable records, e-signatures, and inspection-oriented history. Your quality system still owns intended use.
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.
Part 11 addresses electronic records and electronic signatures. Aureon is designed so regulated objects — samples, results, methods, reviews, and quality events — remain complete, attributable, and retrievable. Audit events are append-only. Signatures carry identity, timestamp, and meaning. We do not claim FDA approval or a “Part 11 certification.”
Assessments typically examine methods, competence, sample handling, and records. Aureon supports method and specification control, training-aware access, chain of custody, and nonconforming-work workflows. Accreditation remains your outcome.
Regulated laboratory data uses statuses such as disposed, obsolete, or superseded rather than silent deletion. The bench can finish with a sample; the record remains for retention and inspection.
IQ/OQ documentation packages and validation support materials are available on request. Customer validation remains the laboratory’s responsibility.
Role-based access control, unique user identity, and optional training gates before regulated actions. See also the security page for hosting and data-handling language.
Questions
It means the product is built with electronic records, attributable audit trails, e-signatures, and lifecycle controls that map to Part 11 topics. It does not mean the FDA has certified the software, and it does not replace your validation.
We will map product controls to your intended use — without over-claiming certification.