LAB SYSTEMSINDEX

Map the system. Preserve the evidence. Test the handoff.

Coverage desk

Manufacturing content governance

Source-backed reporting and analysis connected to the companies, capabilities, authorities, and operating domains it affects.

PAS-X preconfigured content needs effective-version proof

Körber presents PAS-X as modular suites, preconfigured industry solutions, content, analytics, and services spanning development through production and packaging. Vendor content can accelerate design, but it does not become an approved site instruction until scope, version, validation, and effective use are evidenced.

Uncountable AI edits need reviewer and rollback evidence

Uncountable says its Bodie assistant can edit tables, create records, and update fields. State-changing actions need identity, scope, source, preview, approval, version, validation, and reversal controls.

A SampleManager workflow is not the laboratory’s approved procedure

Thermo Fisher Scientific documents SampleManager LIMS capabilities for flexible workflow automation and step-by-step laboratory execution. Configured steps can guide and record work, but the approved procedure, method version, training state, deviation authority, and scientific review remain governed laboratory records.

ISO 15189 keeps point-of-care testing inside medical-laboratory governance

ISO 15189:2022 specifies quality and competence requirements for medical laboratories and states that it is also applicable to point-of-care testing. A result produced near the patient can shorten a handoff, but it does not remove method, device, operator, quality, result-review, clinical-use, and accreditation responsibilities.