🔒BOM
🔒REQ
🔒COMP-A
🔒COMP-B
🔒TEST
Baseline locked · Rev A
LOCKING
A locked baseline is a structural guarantee, not a folder name.
Click lock. Every item, every attribute, every linked child is sealed. Provable. Permanent. Auditable.
Quality Manager
Lock what's certified. Trace every change. Govern who touches what.
Koddex gives quality managers structural guarantees, not naming conventions. Baselines that hold, revisions that are explicit, and audit trails that are always ready.
EU MDR · ISO 13485 · AS9100 · DO-178C / DO-254 · ISO 10218 · IEC 61508 · 10 CFR 50 App. B
Across every regulated industry, certification has shifted from "deliver a binder of documents" to "prove your engineering data was under structural control at every stage." MedTech (EU MDR, FDA QMSR, ISO 13485), aerospace and defense (AS9100, EASA Part 21, DO-178C, DO-254), robotics (ISO 10218, EN ISO 13482, IEC 61508), nuclear and energy (RCC-M, 10 CFR 50 App. B, IAEA SSG-39) and advanced manufacturing (ISO 9001, IATF 16949) all converge on the same requirement: traceable design history, locked baselines, explicit revision lineage, and audit-ready records.
For quality managers, the structural problem is identical regardless of regime: prove the configuration that was certified, prove every change since, and prove who had the right to touch what — without spending weeks reconstructing it.
Most teams' tooling (Word, Excel, shared drives) was never designed for that level of structural proof. Auditors expose the gap.
Koddex closes it upstream, before the QMS layer.
- 01
Auditors demand structured proof, not documents. Whether the regime is EU MDR, AS9100, DO-178C / DO-254, ISO 10218 or 10 CFR 50 App. B, your file must demonstrate continuous traceability from inputs to verified outputs, with explicit version control at every stage. A folder of PDFs doesn't satisfy any of them. The auditor will ask: "Show me the baseline that was in effect when this product was certified." You need to answer without reconstructing it.
- 02
Every post-certification change triggers a re-evaluation cycle. MDR Article 83, AS9100 § 8.5.6, DO-178C § 7 and 10 CFR 50.59 all require documented impact analysis on every design change. Each change must be traced back to affected requirements, risk assessments and verification activities. Without a structured graph, this is weeks of manual work per change.
- 03
"Locked" doesn't mean anything in a shared drive. Your design freeze lives in a folder called _FINAL_v3. Someone edits a file without telling anyone. The configuration drifts. You find out during a Notified Body, FAA or AIB audit — or after a field safety corrective action.
Rev A / 2025-11-14 / J. Martin
Rev B / 2026-01-09 / S. Lecomte
Rev C / 2026-03-22 / A. Nguyen
▮
REVISION LINEAGE
Every revision knows where it came from.
Full history of who created which revision, when, and from which state. No reconstruction. No guesswork.
TEAMvieweditlockmanage
SUPPLIERvieweditlockmanage
AUDITORvieweditlockmanage
PERMISSIONS
The right access. For the right actor. At the right scope.
Assign view, edit, lock, and manage rights by group, by item, by model. Contractors get exactly what they need.
›item_locked / BOM_Senova_RevA / 09:14:02
›revision_created / COMP-117 / 09:15:44
›attribute_edited / mass_kg / 09:17:11
›item_locked / BOM_Senova_RevA / 09:14:02
›revision_created / COMP-117 / 09:15:44
›attribute_edited / mass_kg / 09:17:11
ACTIVITY LOG
Every action. Every actor. Every timestamp.
Full activity log per item, ready for EU MDR, ISO 13485, AS9100, DO-178C / DO-254, ISO 10218, IEC 61508 and 10 CFR 50 audits — without reconstruction.
Certifications changed the standard. Your tooling hasn't.
Whether you certify under EU MDR, AS9100, DO-178C / DO-254, ISO 10218, IEC 61508 or 10 CFR 50 App. B, the underlying audit question is the same: prove that, at the moment of certification, every requirement was linked to a verified output, every component was at a known revision, every baseline was locked, and every change was traceable to an authorized actor.
The gap most teams discover too late: their design control layer (requirements, components, verification, design outputs) lives in disconnected tools with no structural link between them. When the auditor asks "prove that this design output was linked to a validated input at the time of certification," the answer requires days of manual reconstruction.
Koddex structures that layer upstream. Requirements, components, design outputs and test results are explicitly linked in a single graph. Baselines are locked at the item level, not the folder level. Every change is a traceable revision with author, date and reason. When the audit comes — under any regime — the technical file isn't assembled. It's already there.
How Koddex compares for quality managers in regulated industries
| Criteria | Excel / SharePoint | MasterControl / Veeva QMS | PTC Windchill | Koddex |
|---|---|---|---|---|
| Structured engineering objects with typed attributes | ||||
| Item-level baseline locking (structural, not document) | 1 | |||
| Full revision lineage with author, date, predecessor | 2 | |||
| Requirements linked to design outputs in same graph | 3 | |||
| Design change impact trace across full system | 3 | |||
| Granular permissions at individual item level | 4 | |||
| Audit trail per item exportable without reconstruction | ||||
| Deployable by a 100–500 person team without dedicated IT | 5 | |||
| Accessible to AI agents via MCP with full traceability |
- 1.Windchill manages part and document baselines within its PDM structure, scoped to CAD and BOM objects, not arbitrary engineering graph items.
- 2.MasterControl and Veeva track document version history and signatures within their QMS layer, not engineering item revision lineage upstream of the design file.
- 3.Windchill supports requirements linkage via integrations (e.g. with DOORS), not natively within a unified graph.
- 4.Veeva Vault has document-level and vault-level permissions, not item-level permissions on typed engineering objects.
- 5.MasterControl and Veeva are SaaS QMS tools accessible to smaller teams, but they operate on the document layer, not the engineering data layer.
Quality management across our industries
MedTech
Class II–III device makers under EU MDR, FDA QMSR, ISO 13485.
Robotics
Industrial, mobile and humanoid platforms under ISO 10218, EN ISO 13482, IEC 61508.
Aerospace & Defense
AS9100, DO-178C, DO-254 and EASA Part 21 programs with locked baselines.
Nuclear & Energy
RCC-M, 10 CFR 50 App. B, IAEA SSG-39 design control for reactor and SMR systems.
Advanced Manufacturing
ISO 9001 / IATF 16949 plants with structured BOMs and revision control.
Complex Infrastructure
Multi-decade systems with long-lifecycle configuration and audit obligations.
