# Adaptive QMS

> AI-powered Quality Management System for regulated industries. Purpose-built for ISO 9001, ISO 13485, FDA 21 CFR Part 11, MDSAP, EU MDR/IVDR, and GMP/GLP compliance.

Adaptive QMS transforms paper-based quality management into an intelligent, automated compliance platform. Designed for small and mid-size manufacturers, laboratories, and life science companies that need enterprise-grade compliance without enterprise complexity.

## Core Modules

- [Document Control Module (DCM)](https://adaptiveqms.com/dcm): Centralized document governance with compliance-first electronic signatures, version control, audit trails, and automated distribution.
- [Training & LMS Module (TRM)](https://adaptiveqms.com/trm-lms): Automated training management that links document releases to training assignments, competency verification, and closed-loop compliance tracking.
- [HR Management Module (HRM)](https://adaptiveqms.com/hrm): Unified HR lifecycle management covering onboarding, role-based access, competency records, and workforce compliance evidence.

## Key Capabilities

- Electronic signatures with meaning capture (21 CFR Part 11 compliant)
- Immutable audit trails with server-generated timestamps
- Automated training triggers on document release
- Role-based access control and permission management
- Risk-based integration across all modules
- Climate change risk registers (ISO 9001:2015 Amendment 1:2024 ready)
- MDSAP-ready unified compliance evidence

## Regulatory Standards Supported

- ISO 9001:2015 (including Amendment 1:2024)
- ISO 13485:2016
- FDA 21 CFR Part 11 (electronic records and signatures)
- FDA QMSR (effective February 2026, replacing 21 CFR Part 820)
- MDSAP (FDA, Health Canada, TGA, PMDA, ANVISA)
- EU MDR / IVDR
- GMP and GLP

## Key Pages

- [Home](https://adaptiveqms.com/): Overview of the platform and value proposition
- [Features & Modules](https://adaptiveqms.com/features): Complete list of available and upcoming modules
- [Compliance](https://adaptiveqms.com/compliance): Detailed regulatory compliance mapping and FAQ
- [How It Works](https://adaptiveqms.com/how-it-works): Implementation process and timeline
- [Validation](https://adaptiveqms.com/validation): Dual-track software validation approach
- [Request Demo](https://adaptiveqms.com/request-demo): Schedule a personalized demonstration

## Company

- Website: https://adaptiveqms.com
- Contact: https://adaptiveqms.com/request-demo
- Industry: Quality Management Software (SaaS) for regulated industries