CAD Compliance Made Simple: Audit Trails Without the Headache

When the FDA auditor asks "show me every change made to this device between Rev 3 and Rev 7," you'd better have an answer. And "let me search my emails" isn't it.

Regulated industries—medical devices, aerospace, automotive—require documentation of what changed, when, why, and who approved it. Most teams cobble this together with spreadsheets, email archives, and PDM systems that weren't designed for visualization workflows.

The Compliance Documentation Challenge

Engineering teams in regulated industries face multiple documentation requirements:

• FDA 21 CFR Part 11: Design controls, change documentation, electronic signatures
• ISO 13485: Quality management for medical devices, design history file
• AS9100: Aerospace quality management, configuration control
• IATF 16949: Automotive quality, design change records
• ITAR: Defense export controls, access logging, nationality verification

Common thread: you must prove what happened at each stage of design.

Where Current Workflows Fail

What Auditors Actually Want

When an auditor reviews your design history file, they're looking for:

1. Change records: What was changed between versions
2. Timestamps: When did each change happen
3. Attribution: Who made or requested each change
4. Approval evidence: Who reviewed and approved
5. Rationale: Why was this change made (not just what)

How Spatial Comments Create Audit Trails

When design review happens through a 3D viewer with spatial commenting:

Every Comment is Logged

• User ID + timestamp + exact 3D location + camera angle
• Full text of comment preserved
• Thread replies tracked with their own timestamps

Resolution is Documented

• Comment status: Open → In Progress → Resolved
• Who resolved it and when
• Optional: link resolution to specific CAD revision

Version Comparisons are Captured

• Comments from Rev 3 remain visible when viewing Rev 7
• Auditors can see the evolution of feedback
• Export full comment history as compliance artifact

Access Control for Sensitive Data

For ITAR-controlled or confidential designs:

• View tracking: Log every user who accessed a project, when, and for how long
• Link expiration: Automatic access revocation after set period
• Geography restrictions: Block access from non-approved countries (ITAR compliance)
• Zero-retention processing: Files processed in memory only, not stored to disk

See: Zero-Trust Sharing for architecture details.

The Geometry-Lock Compliance Story

If you use AI-assisted visualization, auditors may ask: "How do you know the render matches the approved CAD?"

With geometry-locked generation:

• Output geometry is mathematically constrained to input CAD
• Visual modifications (materials, lighting) cannot alter silhouettes
• Verification pass confirms pixel-level accuracy
• Auditor can trust that the render represents the actual design

Exportable Compliance Artifacts

For design history files, you should be able to export:

FAQ

Further Reading

• Zero-Trust Sharing — Security architecture for IP protection
• Geometry-Lock Protocol — AI accuracy for compliance
• Design Reviews Take Weeks — Speeding up approval cycles