Engineering processes designed for compliance audits

ComplianceMap™ is our AI-powered product for regulated engineering, built on the Kanzen Lifecycle Intelligence Layer. It takes you from product intent to a live, audit-ready engineering environment through a process your team actually works with.

Describe your product in plain language and it reveals the compliance and development process landscape your industry requires. One click publishes that model into your ALM platform: templates, processes, structure, and traceability, set up in minutes instead of days.

Platform-independent and plug-and-play by design, it integrates with virtually any ALM, requirements management, or test management tool, so everything you've invested in your platform keeps its value.

The complete solution includes: process modeling · the ALM platform publisher · industry accelerators · cctivation and adoption through "Week 0" · AI engineering assistance · continuous evolution and governance · "Forensics" memory and context (in development)

Most ALM or requirements management tool implementations fail not because of the tool itself, but because they ignore the connection between development reality, regulatory expectations, and tooling design. Our Kanzen 3-Layer Enablement Model (or "K3LEM") solves this by unifying all three layers — engineering, compliance, and tooling — into one integrated model that mirrors how high-performance organizations really work.

The result is an audit-ready, scalable, low-friction ALM ecosystem that teams end up adopting. This is the model we live and breathe and is directly embedded into everything we do.

From ComplianceMap and the Lifecycle Intelligence Layer, through the Kanzen Accelerate methodology and industry accelerators, and even down to our approach to the initial process health-check.

Every Kanzen journey starts with a conversation. The Process Health-Check is our version of a demo, which includes a focused assessment designed to uncover the gaps, inefficiencies, and risks in your current processes and ALM setup.

This "demo" is designed as a workshop where we review your tools, workflows, traceability, and safety processes against industry standards and your real audit exposure. Then we map your landscape real-time in ComplianceMap, which means you see your industry’s process landscape on screen before you’ve committed to anything.

You leave with a written findings document and a prioritized improvement roadmap that is written by us but is owned by you.

This is the adoption phase of any engagement we take on, and the reason our method works where tools alone fail. A process is only as good as its adoption and a fully configured environment only pays off when your team lives it.

Starting with "Week 0" through five days on-site, two process architects turn ComplianceMap's models into your process. Traceability model, development workflows, and compliance foundations implemented, fine-tuned, and adopted, with advanced, tailored training to match.

Hands-on support and Forensics memory continue through Continuous Evolution.

Automotive safety compliance:

• ISO 26262, ASPICE, ISO/SAE 21434, ISO/PAS 8800 & ISO 21448 (SOTIF)

MedTech compliance:

• ISO 13485, IEC 62304, ISO 10993, IEC 60601, ISO 14971, FDA 21 CFR Part 11, FDA 21 CFR Part 820 (QMSR)

Aerospace compliance:

• DO-178C, DO-254, ARP4754A/B, ARP4761A, DO-326A / ED-202A, DO-330

Data security:

• EU AI Act · EU Data Act · EU GDPR

• ALM & requirements management tool installation and setup

• ComplianceMap-published models

• Rollout of industry accelerators for automotive, medtech, and aerospace

• Optimization of workflows and safety processes

• Responsible AI use

• Full support for tools and configurations

• Advanced, fully customized training

• End-to-end lifecycle management consulting

• Traceability modeling

• Safety-critical systems engineering

• Requirements engineering & requirements management

• Risk management

• Test management

• Config management

• Variants management