AssurX QMS vs qmsWrapper
AssurX QMS
assurx.comqmsWrapper
qmswrapper.comSide by side
| Figure | AssurX QMS | qmsWrapper |
|---|---|---|
| Price from | — | €291.58/mo |
| Free plan | — | — |
| Free trial | — | Yes |
| Open source | — | — |
| Web | Yes | Yes |
| Windows | — | Yes |
| Linux | — | Yes |
| iOS | Yes | — |
| Android | Yes | — |
| API | Yes | — |
| Self-hosted | Yes | — |
| Plans published | 3 | 3 |
| Spec score · Quality Management Software | 8.5 (#5) | 8.0 (#11) |
| Founded | The company says its founders incorporated AssurX in California in March 2000. | 2016 |
| Headquarters | Reno, Nevada, United States | Markham, Ontario, Canada |
| Security | AssurX states that it is ISO/IEC 27001:2022 certified and SOC 2 compliant. | The maker says SOC 2 and ISO 27001 certifications are in progress and offers existing security controls and hosting documentation under NDA. |
| Support | Technical support is available to designated customer contacts by phone, fax, or email, with same-day responses during regional business hours. | The qmsWrapper documentation site provides a contact-support link for users needing help. |
| What it does | AssurX is an enterprise quality-management and regulatory-compliance platform for regulated organizations. | qmsWrapper is an AI-enabled eQMS for medical-device, SaMD, IVD and growing manufacturer teams. |
Plans
AssurX QMS
- AssurX Cloud QMSPrice not published
- AssurX QMSPriced on request
- Custom AssurX subscriptionPriced on request
qmsWrapper
- Foundation€3,499 a year
- LifecyclePriced on request
- VigilancePriced on request
In their own words
AssurX QMS
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.
qmsWrapper
qmsWrapper is a cloud eQMS for medical-device, SaMD, IVD, and growing manufacturer teams. Its Foundation, Lifecycle, and Vigilance levels allow organizations to add capabilities while keeping records and processes in one system. Foundation includes controlled forms and records, documents and approvals, training, tasks, and storage. Lifecycle adds workflows for CAPA, change control, deviations, nonconformities, feedback, suppliers, and risk. Vigilance covers post-market surveillance, Technical File visibility, and audit and regulatory evidence. AI can help complete forms, search documents, assess change impact, and support traceability, while authorized users review and approve regulated decisions. Jira projects and issues can connect to qmsWrapper, appear in its Traceability Matrix, and link to risks. The maker lists electronic signatures aligned with 21 CFR Part 11 and tamper-evident audit trails. It describes the service as pre-validated SaaS, but customers remain responsible for final validation for their intended use. EU and US hosting regions are available. Foundation costs €3,499 a year; a 14-day trial is available.