Arena QMS vs qmsWrapper
Arena QMS
arenasolutions.comqmsWrapper
qmswrapper.comSide by side
| Figure | Arena QMS | qmsWrapper |
|---|---|---|
| Price from | — | €291.58/mo |
| Free plan | — | — |
| Free trial | Yes | Yes |
| Open source | — | — |
| Web | Yes | Yes |
| Windows | — | Yes |
| Linux | — | Yes |
| API | Yes | — |
| Plans published | 3 | 3 |
| Spec score · Quality Management Software | 7.8 (#13) | 8.0 (#11) |
| Compliance | Arena QMS is positioned for regulated manufacturers managing FDA and ISO compliance, including medical device and biotechnology companies. | The maker says the platform supports work aligned with ISO 13485, ISO 14971, FDA QMSR, EU MDR and other listed regulatory frameworks. |
| Founded | 1985 | 2016 |
| Headquarters | Boston, Massachusetts, USA | Markham, Ontario, Canada |
| Security | Arena says its application security measures include data encryption, controlled access, secure integration APIs, redundant backed-up storage, and isolated multi-tenancy. | The maker says SOC 2 and ISO 27001 certifications are in progress and offers existing security controls and hosting documentation under NDA. |
| Support | Arena offers step-by-step in-product help, instructor-led or web-based training, and technical support for QMS customers. | The qmsWrapper documentation site provides a contact-support link for users needing help. |
Plans
qmsWrapper
- Foundation€3,499 a year
- LifecyclePriced on request
- VigilancePriced on request
In their own words
Arena QMS
Arena QMS has no write-up on Specifiction yet; its figures are above.
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.