AssurX QMS vs SimplerQMS

AssurX QMS is configurable quality management and regulatory compliance software for organizations in regulated environments. It automates electronic workflows that can include tasks, alerts, escalations and approvals. Listed functions cover audit, CAPA, calibration, change, complaint, document, risk, supplier quality, training and validation management. Dashboards, real-time KPIs, trending and analytical tools support review of quality activity. The software can be deployed as cloud software or on-premise, including in air-gapped environments, and is described as mobile-friendly on iOS and Android. AssurX offers web services and an open API for integration at no charge. The maker lists experience connecting with ERP, PLM, MES, LIMS, CRM, CMMS, SAP, Salesforce, Oracle and PTC/Windchill. AssurX states that it is ISO/IEC 27001:2022 certified and SOC 2 compliant, and that it encrypts data in transit and at rest with 256-bit encryption. Technical support is available to designated customer contacts by phone, fax or email, with same-day responses during regional business hours. Pricing is on request.

SimplerQMS is a cloud-based electronic quality management system for life science organizations, including medical device, pharmaceutical, biotech, laboratory, and CRO/CMO companies. Its modules cover document control, change management, training, CAPA, audits, design control, supplier and equipment management, and risk management. The platform automates document reviews, approvals, and routing, and links records to support traceability. It provides electronic signatures and time-stamped audit logs that the company says comply with FDA 21 CFR Part 11 and EU GMP Annex 11. Microsoft 365 integration lets users edit Word, Excel, and PowerPoint files and save them to the system; other listed integrations include ERP, CRM, PLM, and WMS, with an API for scripting environments. Single sign-on is available through Microsoft Entra ID and Google Workspace. Subscriptions include implementation, validation, migration, live training, hosting, templates, and 24/7 emergency phone support. A free Viewer license offers unlimited users read-only access. Starter costs $17,500 a year for up to 15 users; pricing for Team & Enterprise is by request.