We don't sell software and walk away. We build your compliance system.

Every engagement starts with your regulatory requirements, your product type, and your audit timeline.

Our approach

Process design first, then the system to run it

Business layer - quality process design

  • Before configuring software, we map your quality processes - document types, approval chains, training requirements
  • Pre-built quality modules adapted to your product type, regulatory path, and organizational stage
  • You get a system right-sized for where you are today, not an enterprise template or a blank canvas

Automation layer - QMS engine

  • Extensible platform that runs your quality processes with immutable audit trails
  • Integrates with ERP, LIMS, and existing tools where needed
  • Quality teams adjust workflows; developers extend with code when you outgrow standard modules

Timeline

Configured and recording in 3 weeks

Document control, CAPA, training, change control, audit management - configured for your processes and recording quality activities.

1

Week 1: Discovery

Your product, your stage, your audit timeline

2

Week 2: Configuration

Document types, workflows, user roles, approval chains

3

Week 3: Go-live

Working QMS recording quality activities

Investment

$15-30K

Depending on scope and integrations

Outcome

Audit-ready quality management system

Your team can operate and extend

Independence

Your system, your terms

Your data

Full sovereignty, export everything, no analytics on your business logic

Your deployment

Cloud, self-hosted, air-gapped - mix as needed

Your team

Standard code output, your developers can maintain without us

Your quality records

Your quality data remains your asset, regardless of vendor choice

Who we work with

Buying committee

  • Compliance / Quality Leader
  • VP Operations
  • IT / Security

What they care about

  • Passing audits and regulatory examinations
  • Right-sized system, not enterprise-bloated
  • Budget that doesn't consume the compliance budget

Company size

50-2000 employees across regulated industries

Industries

Pharma, medical devices, banking - regulated companies that need audit-ready systems

Ready to get audit-ready?

Your compliance system, configured and audit-ready in weeks.