What this domain asks
The control system for assigning identity, preserving parent-child and container relationships, recording location and custody, managing quantity and condition, and retaining every material transition from receipt through disposition.
The domain should retain its own evidence, decision owner, materiality criteria, exception path, and consequence even when it shares organization identity, workflow, or technology with adjacent domains. Aggregation can support oversight; it should not erase the evidence behind different risks or operating outcomes.
Buyer questions
- Which identifier is authoritative at each boundary?
- How are splits pools derivatives and re-labeling retained?
- What evidence records receipt transfer storage and disposal?
- How are quantity condition and temperature exceptions handled?
- Can a result be traced to the exact material and process history?
Mapped workflows
Sample Registration Identity And Lifecycle Management
A demonstration should show the trigger, source, accountable role, decision, exception, evidence, and downstream handoff for sample registration identity and lifecycle management within this domain.
Aliquot Batch Container And Chain-Of-Custody Management
A demonstration should show the trigger, source, accountable role, decision, exception, evidence, and downstream handoff for aliquot batch container and chain-of-custody management within this domain.
Biobank Specimen And Storage-Location Management
A demonstration should show the trigger, source, accountable role, decision, exception, evidence, and downstream handoff for biobank specimen and storage-location management within this domain.
Inventory Reagent Standard And Consumable Management
A demonstration should show the trigger, source, accountable role, decision, exception, evidence, and downstream handoff for inventory reagent standard and consumable management within this domain.
Electronic Signatures Audit Trails And Record History
A demonstration should show the trigger, source, accountable role, decision, exception, evidence, and downstream handoff for electronic signatures audit trails and record history within this domain.
Authority context
21 CFR 211.194
The section specifies content for laboratory records, including samples, methods, test data, calculations, results, initials, dates, second-person review, and investigation references.
ISO/IEC 17025:2017
ISO/IEC 17025 specifies requirements for laboratory competence, impartiality, and consistent operation across resources, processes, and management systems.
ISO 15189:2022
ISO 15189 specifies quality and competence requirements for medical laboratories, including governance, resources, pre-examination, examination, post-examination, information, risk, and improvement.
Relevant operating models
- Enterprise LIMS And Laboratory-Informatics Suite
- Configurable Specialist And Midmarket LIMS
- Clinical, Biobank, And Sample-Management Platform
Evidence boundary
Lab Systems Index provides market, standards, regulatory, product, and operating research. It does not validate a computerized system, certify Part 11 or GxP compliance, accredit a laboratory, approve a method, determine scientific validity, interpret patient results, or replace laboratory, quality, validation, regulatory, security, legal, data-integrity, or scientific review. A provider's documented capability can identify a research candidate but cannot establish buyer-specific adequacy for this domain.