Map the system. Preserve the evidence. Test the handoff.
Source-backed reporting and analysis connected to the companies, capabilities, authorities, and operating domains it affects.
SiLA 2 addresses service-oriented device and system communication, Allotrope separates a scientific data format, model, and ontology, and AnIML defines an XML-based analytical-data structure. A lab architecture can use more than one, but each boundary needs an explicit version and mapping.
21 CFR 211.160 requires written laboratory controls with scientifically sound specifications, standards, sampling plans and test procedures, including quality-control-unit review and approval. A laboratory should resolve the governing approved version before sampling or testing begins and preserve any later deviation or change separately.
The emerging ASTM XML standard can structure analytical records across systems without proving that a conversion, method, or result is valid.
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.
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.
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.
FDA's scope guidance requires a buyer to identify applicable predicate rules, electronic records, reliance, signatures, copies, and retention before evaluating controls.
The guidance connects complete data to metadata, audit trails, access, processing, review, investigation, and retained records across instruments and applications.
The official annex connects risk, suppliers, validation, operation, change, security, incidents, continuity, and archiving in one computerized-system lifecycle.
The regulator's publication page preserves its GxP guidance while noting that OECD Advisory Document No. 22 takes precedence for GLP data integrity.
The standard places software-supported records inside a wider system of impartiality, competence, resources, methods, equipment, sampling, handling, technical records, reporting, and improvement.
