The problem you recognise
Your Design History File, Design Basis Documentation, and RAMS evidence are scattered across PLM, ERP, DOORS, Excel, and SharePoint. Every regulatory submission requires weeks of evidence assembly that should take hours. The data is correct. The problem is that nobody has built a query against it — and there is no system that can.
Change management is a bureaucratic necessity, but the audit trail dies in email threads and CM tickets that do not reference the design intent. You can show the approver and the date. You cannot show the rationale, the baseline the change was made against, or the invariant constraints it was required to respect.
The standard differs — AS9100, ISO 13485, NQA-1, ISO 26262, EN 50126 — but the pain is the same: evidence assembly is a manual, error-prone, months-long exercise, every time. When the auditor finds a gap, you discover it after three weeks of work, not before.
What Clarity does for you
Structured audit trail — queryable at audit time. The full L0→L5 traceability chain is a live graph, not a document collection. Requirement to architecture, architecture to options, options to analysis, analysis to baseline, baseline to decision — every node carries @source provenance: who created it, from what document, when, and who reviewed it. AI generation and human overrides are both recorded at every node. The auditor navigates it directly; you do not assemble it.
ISO 10007 change management — structural, not configurable away. Every change in Clarity has proposedAt, proposedBy, approvedBy, fieldPath, rationale, and invariantStatus recorded. This is the schema. It is not a workflow someone can bypass. The change record references the baseline the change was made against and the decision that authorised it. The trail that used to die in email now lives in the digital thread.
Domain packs — evidence generated against the standard, not assembled around it. AS9100, ISO 13485, NQA-1, ISO 26262, and EN 50126 standards overlays are built in. The Lx model is generated with the standard as a constraint, not mapped to the standard retrospectively. When your auditor needs ISO 13485 §7.3.7 design verification evidence, Clarity generates a report from the live model against that specific standard — in minutes.
Scope-matrix reporting — any report, any standard, any combination. 13 lifecycle verticals × 39 assessment layers × standards overlays. The report scope is combinatorially defined, not selected from a catalogue. Formatted, current, traceable to the entities that produced it. Generated in seconds, not assembled in Word over weeks.
Why this matters specifically to you
The downstream consequences of a weak audit trail are budget and schedule events:
- FDA / TGA / NQA-1 audit finding — traceability gap requires corrective action; corrective action delays product release; product release delay in a regulated sector has a direct revenue consequence
- AS9100 audit non-conformance — customer notification required; risk of supply-chain disqualification
- Design History File assembled under time pressure — gaps found after submission, not before; the cost of fixing a DHF gap post-submission is ten times the cost of maintaining it correctly throughout the programme
- Change management failure — a change made without a complete rationale record becomes a root-cause mystery at the next audit; investigations are expensive; liability exposure follows
Clarity eliminates the assembly cost and closes the trail gaps before the auditor arrives.
How it works
- The Lx chain is built at programme inception — not assembled at audit time. L0 extracts requirements and constraints from source documents with
@sourceprovenance on every entity. - Every change is recorded at the API level. There is no pathway through Clarity that produces a change without a change record. Invariant constraints are enforced before the change is approved — three-ring enforcement prevents downstream propagation of constraint violations.
- Domain pack overlays apply at generation time. The AS9100, ISO 13485, or NQA-1 framework is applied during AI generation, not mapped retrospectively. The evidence chain is correct by construction.
- Reports are computed projections from live data. No separately maintained documents. The report that the auditor sees is generated from the same entities that drove the engineering decisions — always current, always traceable.
- Baseline diff on demand. Compare any two baselines. Every difference is a queryable change record with rationale and approval.
Your entry path
For regulated-sector quality leads and compliance officers — enterprise evaluation.
Contact us to discuss your specific standard requirements, domain pack coverage, and deployment model (SaaS, own-account, or air-gapped classified).
→ Request enterprise evaluation
For SMB quality managers with an audit approaching — free tier.
Three users, one product, full L0–L5 model. Start today with no credit card.
→ Start free at compliancewithclarity.com
Read more
- Sovereign Compliance for the 14 Eyes Nations — regulatory and sovereignty framework coverage in depth
- Breaking the DIKW Ceiling — why document-based audit trails are structurally insufficient
- The DeZolve Decision Intelligence Framework — how the evidence coverage panel scores decision trustworthiness
- Thirteen Lifecycle Phases, One Graph — the full lifecycle traceability chain
- Standards coverage — complete regulatory framework coverage