Question 1

What is Adaptive QMS?

Accepted Answer

Adaptive QMS is an AI-powered Electronic Quality Management System (eQMS) built for regulated industries including Medical Devices, Life Sciences, and Pharmaceuticals. It automates document control, training management, HR compliance, and regulatory reporting for ISO 13485, FDA QMSR, 21 CFR Part 11, MDSAP, and EU MDR/IVDR.

Question 2

Which regulatory standards does Adaptive QMS support?

Accepted Answer

Adaptive QMS supports ISO 13485:2016, ISO 9001:2015 (including Amendment 1:2024), FDA QMSR (effective February 2026), FDA 21 CFR Part 11, FDA 21 CFR Part 820, MDSAP, EU MDR/IVDR, EU Annex 11, GMP, and GLP.

Question 3

Is Adaptive QMS pre-validated?

Accepted Answer

Yes. Adaptive QMS provides pre-executed supplier IQ/OQ qualification documentation. Customers execute PQ (Performance Qualification) using our fully templated scripts, inheriting our validation work and dramatically reducing time and cost to achieve compliance.

Question 4

How long does implementation take?

Accepted Answer

Most organisations are fully operational and audit-ready within 6–10 weeks. The process covers demo and scoping, system configuration, software validation using provided IQ/OQ/PQ templates, and go-live with team training.

Question 5

What is the pricing model for Adaptive QMS?

Accepted Answer

Adaptive QMS uses a demo-first SaaS pricing model. Pricing is tailored to organisation size, active users, and modules required. Request a personalised demo at adaptiveqms.com/request-demo to receive a custom quote.