AI-powered Quality Management

Supercharge Your QMS Compliance

Unify document control, risk management, training, and audits in one AI-powered platform — built for life sciences teams.

Welcome to your dashboard

Platform

One unified platform. Three pillars that work together.

Running quality checks...
1.Reviewing SOP-QA-012 v3.1...
2.Linking CAPA-2026-04 to AUD-003...
3.Verifying audit trail integrity...
4.Updating compliance status...
5.Generating quality report...
6.Cross-referencing NCRs...
7.Validating e-signatures...
1.Reviewing SOP-QA-012 v3.1...
2.Linking CAPA-2026-04 to AUD-003...
3.Verifying audit trail integrity...
4.Updating compliance status...
5.Generating quality report...
6.Cross-referencing NCRs...
7.Validating e-signatures...

Quality Management

Document control, CAPA, audits, and nonconformance — all connected.

Tracking lifecycle...
Design review v2.3 approved
Validation protocol overdue
Risk assessment completed
Transfer to production ready
Post-market report pending
Design review v2.3 approved
Validation protocol overdue
Risk assessment completed
Transfer to production ready
Post-market report pending

Product Lifecycle

From design through commercialization, manage every phase with confidence.

Scanning regulations...
1.Checking ISO 13485:2016...
2.Analyzing FDA 21 CFR 820...
3.Scanning EU MDR updates...
4.Cross-referencing IVDR...
5.Detecting compliance gaps...
6.Generating gap report...
7.Prioritizing remediation...
1.Checking ISO 13485:2016...
2.Analyzing FDA 21 CFR 820...
3.Scanning EU MDR updates...
4.Cross-referencing IVDR...
5.Detecting compliance gaps...
6.Generating gap report...
7.Prioritizing remediation...

Compliance Intelligence

AI-powered gap analysis and real-time regulatory monitoring.

Features

Everything your team needs to stay audit-ready and compliant — powered by AI.

AI Assistant
Generate SOP for equipment calibration
Ask about compliance...

Medical Devices

FDA 21 CFR 820
ISO 13485
EU MDR
IVDR

Pharma

21 CFR Part 211
ICH Q10
EU GMP Annex 11

Biotech

GCP
GLP
ICH E6 (R2)
ISO 14155

CROs

GCP
GLP
ISO 9001
Multi-sponsor QMS

See it in action

Book a walkthrough with our team. We'll show you how EQMS fits your workflow.

Or explore on your own