One system. Every quality process connected. AI that finds risk before you do. Trusted by 18,500+ organizations.
Non-conformances slip. Documents go stale. Audits become fire drills. Ideagen connects document control, CAPA management, audits, training, supplier quality and inspection in one platform.
Every record traceable. Every workflow structured. ISO 9001 (including the 2026 edition), ISO 13485, 21 CFR Part 11, AS9100, IATF 16949 - built in. No bolt-ons.
Every standard met. Every record audit ready. Ideagen's quality management system is built so regulated industries never have to chase compliance again.
Nuffield Health. South Tees NHS. Both chose our QMS to centralize pathology compliance, streamline CAPA and hit ISO 9001 and ISO 15189 – across every site.
Centralized CAPA, calibration, training and EU GMP compliance across 3 sites. Torbay Pharmaceuticals did it. So can you.
BSL-3 labs and clinical trials can't run on paper. Duke University Medical Center digitized SOPs, audits and incident reporting – and eliminated the risk.
ISO 9001, non-conformance trending and PDCA – built for manufacturing operations. 6,000+ customers use it daily. The results speak for themselves.
Calculate your ROI with Ideagen
Find out how much time your quality team is losing to manual document control, CAPAs and audits, and what you'd get back with Ideagen Quality Management.
Automatically track ISO standards and regulatory changes across all jurisdictions. New requirements embed directly into existing workflows – with full audit trails and clear change impact visibility.
Don't just fix the problem. Stop it coming back. Automated CAPA workflows deliver systematic root cause analysis and predictive insights. Audit scores improve by 25–40%.
Audits shouldn't be fire drills. Automated evidence, adaptive checklists and real-time collaboration keep you ready – ISO 15189, MHRA, FDA. Every finding traced to action.
Your quality standards are only as good as your team's training. Automated competency tracking, refresher scheduling and GCP/ISO alignment – new hire training cut by 40%.
Verdantix's independent Green Quadrant analysis evaluates 14 QMS platforms serving life sciences, healthcare and manufacturing. See how Ideagen earned the highest scores for AI operations, workflow automation and supplier management. Access this $3,000 report courtesy of Ideagen.
Mazlan doesn't just tell you what happened. It tells you where risk is forming before the audit, before the recall, before the board asks. Three days of investigation becomes three hours. 80%+ adoption on the floor.
Human-approved, every time.
Your quality management system doesn't work in isolation. Ideagen Hub connects quality, EHS, compliance and risk – same data, same audit trail, same view.
Through our calibration and maintenance records stored in [Ideagen], we can prove to inspectors – the MHRA, for example – that our equipment does what it says it does.
Whether you manage 5 sites or 500, we've seen your quality challenges before. This demo shows exactly how we solve them – from CAPA to Mazlan AI.
What you'll see in the demo
Includes a personalised walkthough tailored to you organization.
No login. No sales call. No pressure. Just real document control, CAPA and audit workflows running in environments like yours. See it when you're ready.
Document control, CAPA management, audit management, inspection management, training and competency management, supplier quality management and regulatory intelligence, all in one connected QMS platform.
ISO 9001 (including the 2026 edition), ISO 13485, 21 CFR Part 11, AS9100, IATF 16949, ISO 17025 and more built directly into the workflows. You don't check for compliance. You just are compliant.
Yes. Ideagen Quality Management supports ISO 9001:2026, published in September 2026. Document control, CAPA, audit, risk and training and competence run in one connected system, so the evidence the 2026 edition asks for comes from day-to-day work.
30 days to go live. Our AI configures itself through natural conversation, not months of requirements workshops. We've done this 18,500 times. We know what you need before you ask.
Every Mazlan AI output – from root cause suggestions to drafted reports – requires human review and approval. Accountability stays with your team. AI does the heavy lifting; you make the decisions.
Yes. Ideagen is built for enterprise-scale quality management. Standardize processes globally while giving regional teams the flexibility they need. One platform. Every site. Full visibility.
Our team knows your industry. If your question isn't answered above, talk to us. No sales pitch, just answers.
