The LDLC Map makes relationships navigable. Start from a requirement and trace its governance implications. Start from a document and understand its position in the governed architecture.
The LDLC numbering system is not a filing convention. It is an ontology. Each prefix denotes a fundamentally different kind of object with different governance rules.
The deliverable, controlled output, or governed record. DHF 100624, DMR 100518, V&V Protocol 100427, Hazard Analysis 100312, Technical Documentation 100781. Documents are issued, revised, and governed by the QMS.
The notice, requirement, statement, record content, or governed information object. URS 401042, TDR 401087, ECN 401247, Verification Acceptance Criterion 401427. Distinct from the document that contains them.
The action, activity, or task. Create ECN 600247, Conduct Design Review 600311, Execute Verification 600412, Perform Design Transfer 600515. The work that governs and produces documents and information units.
Individual manufactured units with unique serial identifiers. Distinguished from models (3xxxxxx) and stockable parts (9xxxxxx). Each serialized unit links to its DHR and production records.
Device models or product configurations. Model 300005: Accu-Seal 6300SP Heat Sealer — Impulse Heat. The model is the governed configuration baseline to which all design and production records trace.
7xxxxxx: Accounts — material suppliers (700021), regulatory reviewers (700034), contract manufacturers (700052). 9xxxxxx: Stockable Parts — polymer resin (900118), patient-contacting components (900221).
A governed trace path shows every step from user need to production specification, with every governed relationship along the way.
In a governed system, this trace is unambiguous. URS 401042 → TDR 401087 is a governed derivation relationship. TDR 401087 → Hazard Analysis 100312 is a governed risk input relationship. Each arrow has a defined governance rule. Each relationship is maintained under ECN 401247 / Work Unit 600247.
The full interactive LDLC Map is under development. Contact to discuss early access or framework application.
Request Early AccessThe framework applies to your actual documents, information units, and work units — not to a demonstration dataset.