qmsWrapper vs Qualsmart

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.

Qualsmart is cloud software organized into modules for quality management and food safety compliance. Smart Regulatory offers food regulation searches by country and commodity, alerts, and risk assessment models. Smart HACCP supports digital food safety plans, risk matrices, process flow diagrams, and CCP/PCP determination. Smart Lab manages sample workflows, customer portals, quotations, analysis planning, audit trails, electronic signatures, and lab assets. Smart Record provides a form builder with more than 36 field types, conditional rules, validations, and record traceability; its iOS and Android apps can create records offline and sync when connectivity returns. Other modules cover documents, suppliers, audits, compliance, specifications, environmental monitoring, training, recalls, corrective actions, visitors, and identity and access management. Smart Docs includes document workflows, version control, audit logs, search, and PDF export, and supports document controls aligned with 21 CFR Part 11. The company also describes IoT connections, blockchain-based supply-chain traceability, regional cloud hosting, and security controls including role-based access, SSO, and MFA. Qualsmart is available on the web, Android, iOS, and through an API. Pricing is on request.