Lab Systems Index

Lab Systems Indexhttps://labsystemsindex.com/2026-07-19T20:15:00.000ZFDA's CSA record keeps assurance tied to intended use and process riskhttps://labsystemsindex.com/news/fda-csa-keeps-assurance-tied-to-intended-use/2026-07-19T20:15:00.000Z2026-07-19T20:15:00.000ZLab Systems Index Research Desk

The current guidance frames confidence in production and quality-system software around intended use, risk, appropriate assurance activity, issues, and retained evidence—not documentation volume.

Part 11 scope starts with the record—not the feature checklisthttps://labsystemsindex.com/news/part-11-scope-starts-with-the-record/2026-07-19T19:15:00.000Z2026-07-19T19:15:00.000ZLab Systems Index Research Desk

FDA's scope guidance requires a buyer to identify applicable predicate rules, electronic records, reliance, signatures, copies, and retention before evaluating controls.

FDA's data-integrity record keeps metadata and review in the laboratory system maphttps://labsystemsindex.com/news/data-integrity-requires-metadata-and-review/2026-07-19T18:15:00.000Z2026-07-19T18:15:00.000ZLab Systems Index Research Desk

The guidance connects complete data to metadata, audit trails, access, processing, review, investigation, and retained records across instruments and applications.

EU GMP Annex 11 keeps vendor and system-owner responsibilities visiblehttps://labsystemsindex.com/news/annex-11-keeps-vendor-and-owner-responsibilities-visible/2026-07-19T17:15:00.000Z2026-07-19T17:15:00.000ZLab Systems Index Research Desk

The official annex connects risk, suppliers, validation, operation, change, security, incidents, continuity, and archiving in one computerized-system lifecycle.

MHRA's current page points GLP readers to the later OECD data-integrity advisoryhttps://labsystemsindex.com/news/mhra-points-readers-to-oecd-data-integrity-guidance/2026-07-19T16:15:00.000Z2026-07-19T16:15:00.000ZLab Systems Index Research Desk

The regulator's publication page preserves its GxP guidance while noting that OECD Advisory Document No. 22 takes precedence for GLP data integrity.

ISO/IEC 17025 is a laboratory competence system—not a LIMS badgehttps://labsystemsindex.com/news/iso-17025-is-a-competence-system-not-a-lims-badge/2026-07-19T15:15:00.000Z2026-07-19T15:15:00.000ZLab Systems Index Research Desk

The standard places software-supported records inside a wider system of impartiality, competence, resources, methods, equipment, sampling, handling, technical records, reporting, and improvement.

SiLA 2 standardizes an interface model—not laboratory workflow fitnesshttps://labsystemsindex.com/news/sila-2-standardizes-interfaces-not-workflow-fitness/2026-07-19T14:15:00.000Z2026-07-19T14:15:00.000ZLab Systems Index Research Desk

The official standard record helps device and platform teams compare service definitions, commands, properties, metadata, and communication while leaving safety, method, data, and operating assurance separate.

Allotrope separates scientific format, data model, and controlled terminologyhttps://labsystemsindex.com/news/allotrope-separates-format-model-and-ontology/2026-07-19T13:15:00.000Z2026-07-19T13:15:00.000ZLab Systems Index Research Desk

The official framework makes an important architecture distinction: storing a file, structuring scientific context, and aligning semantic terms are related but different responsibilities.

LabVantage's current portfolio shows LIMS, ELN, LES, and SDMS convergence without erasing the boundarieshttps://labsystemsindex.com/news/labvantage-portfolio-shows-suite-convergence/2026-07-19T12:15:00.000Z2026-07-19T12:15:00.000ZLab Systems Index Research Desk

The official informatics record spans sample operations, experiment records, procedure execution, scientific-data management, analytics, and specialty workflows on one portfolio.

Agilent SLIMS connects laboratory workflow with the OpenLab analytical ecosystemhttps://labsystemsindex.com/news/agilent-slims-connects-lab-workflow-and-analytical-data/2026-07-19T11:15:00.000Z2026-07-19T11:15:00.000ZLab Systems Index Research Desk

The current product record combines LIMS, ELN, and LES positioning with instrument and analytical-data connections, creating a useful system-boundary test for buyers.

Waters' current Empower record keeps CDS release and lifecycle questions visiblehttps://labsystemsindex.com/news/waters-empower-current-release-keeps-cds-change-visible/2026-07-19T10:15:00.000Z2026-07-19T10:15:00.000ZLab Systems Index Research Desk

The product page documents the current chromatography data-system family while buyers still need version-specific evidence for instruments, processing, controls, interfaces, migration, and retained records.

TetraScience's Tetra OS record clarifies the scientific-data platform boundaryhttps://labsystemsindex.com/news/tetra-os-clarifies-data-platform-boundary/2026-07-19T09:15:00.000Z2026-07-19T09:15:00.000ZLab Systems Index Research Desk

The official platform record centers ingest, engineering, harmonization, context, data products, and application access rather than replacing the LIMS, ELN, CDS, or instrument that creates an operational record.