qmsWrapper vs SafetyChain
qmsWrapper
qmswrapper.com
SafetyChain
safetychain.comSide by side
| Figure | qmsWrapper | SafetyChain |
|---|---|---|
| Price from | €291.58/mo | — |
| Free plan | — | — |
| Free trial | Yes | — |
| Open source | — | — |
| Web | Yes | — |
| Windows | Yes | Yes |
| Linux | Yes | — |
| iOS | — | Yes |
| Android | — | Yes |
| API | — | Yes |
| Plans published | 3 | 3 |
| Spec score · Quality Management Software | 8.0 (#11) | 6.8 (#28) |
| Security | The maker says SOC 2 and ISO 27001 certifications are in progress and offers existing security controls and hosting documentation under NDA. | SafetyChain states it completed a SOC 2 Type 2 certification audit covering security, availability, and confidentiality controls over a six-month review period. |
Plans
qmsWrapper
- Foundation€3,499 a year
- LifecyclePriced on request
- VigilancePriced on request
SafetyChain
- AdvancedPriced on request
- EssentialPriced on request
- SupplierPriced on request
In their own words
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.
SafetyChain
SafetyChain has no write-up on Specifiction yet; its figures are above.