Data Standards
AnIML separates analytical data exchange from scientific validity
The emerging ASTM XML standard can structure analytical records across systems without proving that a conversion, method, or result is valid.
Coverage desk
Data Standards
Source-backed reporting and analysis connected to the companies, capabilities, authorities, and operating domains it affects.
Regulation & Standards
21 CFR 211.194 makes the laboratory record a reconstructable test chain
For drug CGMP laboratory records within its scope, 21 CFR 211.194 connects the sample, method, raw data, calculations, result, performer, and second-person review. A final result in a LIMS is not the complete record when the source observations and review path cannot be reconstructed.
Regulation and Standards
NIH's 2026 DMS format makes data-lifecycle commitments explicit
The required simplified plan asks direct questions about sharing, timing, retention, limitations, participant protections, data types, and repositories. Lab systems need to connect those approved commitments to actual data and deposits without mistaking a plan for proof of execution.
Regulation and Standards
FDA's CSA record keeps assurance tied to intended use and process risk
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.
Regulation and Standards
Part 11 scope starts with the record—not the feature checklist
FDA's scope guidance requires a buyer to identify applicable predicate rules, electronic records, reliance, signatures, copies, and retention before evaluating controls.
Regulation and Standards
FDA's data-integrity record keeps metadata and review in the laboratory system map
The guidance connects complete data to metadata, audit trails, access, processing, review, investigation, and retained records across instruments and applications.
Regulation and Standards
EU GMP Annex 11 keeps vendor and system-owner responsibilities visible
The official annex connects risk, suppliers, validation, operation, change, security, incidents, continuity, and archiving in one computerized-system lifecycle.
Regulation and Standards
MHRA's current page points GLP readers to the later OECD data-integrity advisory
The regulator's publication page preserves its GxP guidance while noting that OECD Advisory Document No. 22 takes precedence for GLP data integrity.
Regulation and Standards
ISO/IEC 17025 is a laboratory competence system—not a LIMS badge
The standard places software-supported records inside a wider system of impartiality, competence, resources, methods, equipment, sampling, handling, technical records, reporting, and improvement.