GatesFlow QMS vs qmsWrapper
GatesFlow QMS
gatesflow.comqmsWrapper
qmswrapper.comSide by side
| Figure | GatesFlow QMS | qmsWrapper |
|---|---|---|
| Price from | $20/mo | €291.58/mo |
| Free plan | Yes | — |
| Free trial | Yes | Yes |
| Open source | — | — |
| Web | Yes | Yes |
| Windows | — | Yes |
| Linux | — | Yes |
| iOS | Yes | — |
| API | Yes | — |
| Plans published | 4 | 3 |
| Spec score · Quality Management Software | 9.0 (#3) | 8.0 (#11) |
| AI features | Dedicated AI agents, natural-language queries, predictive analytics and an NLP-powered custom-module builder are advertised. | AI assists with form completion, document search, change-impact analysis and traceability, while authorized users review and approve regulated decisions. |
| Headquarters | LinkedIn lists headquarters at 633 Chestnut Street in Chattanooga, Tennessee. | Markham, Ontario, Canada |
| Security | GatesFlow states that data is encrypted with TLS 1.3 in transit and AES-256 at rest, with RBAC and MFA available for all accounts. | 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 for existing customers is available 24/7 via [email protected]. | The qmsWrapper documentation site provides a contact-support link for users needing help. |
| What it does | GatesFlow combines PLM, QMS, MES, ERP, CAD collaboration, inventory, finance and HR functions in one manufacturing platform. | qmsWrapper is an AI-enabled eQMS for medical-device, SaMD, IVD and growing manufacturer teams. |
Plans
GatesFlow QMS
- FreeFree
- Paid plans$20 a month
- Paid plans starting at$20 a month
- Visitor Kiosk$150 a month
qmsWrapper
- Foundation€3,499 a year
- LifecyclePriced on request
- VigilancePriced on request
In their own words
GatesFlow QMS
GatesFlow QMS is cloud-based quality-management software for manufacturing, covering FMEA, PPAP, control plans, inspections, and corrective and preventive actions. It is designed to support requirements including IATF 16949, ISO 9001, AS9100, ISO 13485, FDA 21 CFR Part 11, APQP, and PPAP. FMEA tools handle design and process records, risk ratings, automated RPN calculations, and action tracking. PPAP workflows track 18 elements and support multi-level submissions. CAPA tools cover non-conformances, root-cause analysis, corrective and preventive actions, and 8D reports. The system also supports internal, supplier, and customer audits, supplier scorecards, incoming inspection, and supplier PPAP approvals. FMEAs, control plans, and inspections can link to bills of materials, drawings, and specifications for product-to-quality traceability. GatesFlow describes AI agents for analyzing quality trends, predicting failures, and recommending corrective actions. A free account has no trial clock and requires no credit card; paid plans start at $20 per month. The service lists web and API access, approval workflows, document control, and integrations including Plex, SAP, Oracle, and NetSuite.
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.