Synesis International is excited to announce the launch of the new generation of Synesis QMS — a comprehensive, AI-powered electronic Quality Management System purpose-built for manufacturers. Fourteen integrated modules. Closed-loop traceability. Predictive analytics. And a deployment model that puts you in control of where the system runs.
Why a New QMS Now
Quality teams have been asked to do more with less for years. Customer specs are tighter. Audits are more frequent. Supplier risk is harder to predict. And the systems most quality organizations rely on — shared drives for SOPs, spreadsheets for CAPAs, email chains for approvals — are not built for this level of demand. Synesis built the new QMS to close those gaps with intelligent automation, complete traceability, and the kind of intuitive interface modern manufacturing teams expect.
What's in the Platform
Synesis QMS now ships with eight platform module families, each with its own workflow, capability set, and ISO compliance coverage:
- Document Management — ISO 9001 compliant document control with full review and approval workflow, version history, published documents library, retention controls, and read-and-understand acknowledgments.
- Quality Events — Nonconformances, CAPA (six-step workflow with AI-assisted root cause), RMA, RGA, change control, and customer complaints — all linked through closed-loop traceability.
- Quality Operations — Audits (internal, supplier, process, system, layered, regulatory), receiving and in-process inspections, calibration, and quality-critical equipment management.
- Supplier & Risk — Qualification, AI-powered scorecards, SCARs, and a 5×5 risk register with automatic RPN scoring and predictive risk intelligence.
- Training Management — Role-based assignment, document-driven retraining, instructor scheduling, and audit-ready competency evidence.
- Reports, KPI and Dashboards — Drillable KPIs, document process analytics, ISO 9001 §9.3 management review, and Excel and Power BI exports.
- Approval Workflows — Three-channel approvals (in-app, email magic-link, Microsoft Teams) with first-response-wins idempotency and electronic signatures.
- ERP Connect — Native two-way integration with SAP Business One, SAP S/4HANA, Syspro, and Microsoft Dynamics 365.
AI Working Underneath Every Module
Artificial intelligence is built into every QMS module, not bolted on. AI assists with root cause analysis on nonconformances and CAPAs, classifies and routes quality events, predicts supplier risk, generates document descriptions and learning objectives, scores audit readiness, and identifies systemic issues across complaints, NCRs, and supplier batches before they cascade. The AI gets sharper as it runs, because it learns from your quality data — your processes, your suppliers, your customers.
Compliance, By Design
Synesis QMS supports the standards manufacturers actually have to meet: ISO 9001:2015, IATF 16949 (automotive), AS9100 (aerospace), ISO 13485 (medical devices), FDA 21 CFR Part 820 and Part 11, EU GMP Annex 11, SQF and BRC for food and beverage, and ISO 17025 for accredited calibration labs. Workflows, audit trails, electronic signatures, and reports are all built around real audit questions, so audit prep collapses from weeks of evidence gathering to minutes of report exporting.
Deploy Where You Want
Synesis QMS is hosting-agnostic. You choose where it runs:
- On-premise behind your firewall, alongside an on-premise SAP or other ERP system
- Microsoft Azure integrated natively with your existing Azure tenant and Microsoft 365 environment
- Amazon Web Services (AWS), leveraging your existing AWS infrastructure and security posture
- Any hosted provider — your IT team chooses the deployment that fits your security, compliance, and operational requirements
The same software runs the same way regardless of where it lives. No vendor lock-in. No forced cloud migration. No per-user Microsoft 365 license requirement — even though Synesis QMS integrates deeply with SharePoint, Teams, Outlook, Azure, Power Automate, Power BI, and Microsoft Copilot.
Available Now
Synesis QMS, MES, and CMMS are available immediately for new and existing customers. The platform runs on a modern Microsoft license-free architecture and deploys where you choose — on-premise, on Microsoft Azure, on Amazon Web Services, or on the hosted solution of your choice. No vendor lock-in. No per-user Microsoft 365 license dependency.
Part of an Integrated Manufacturing Platform
Synesis QMS is the quality pillar of a three-system manufacturing platform that also includes Synesis MES for production execution and Synesis CMMS for asset and maintenance management. The three systems share data, share workflows, and share an AI engine that learns across quality, production, and maintenance.
Get Started
Synesis QMS, MES, and CMMS are available now for manufacturers across automotive, aerospace, life sciences, food and beverage, textile and apparel, packaging, and discrete and process manufacturing. The Synesis team — with 30 years of manufacturing IT consulting experience — provides implementation, configuration, training, and ongoing optimization for every deployment.
Learn more about Synesis QMS or contact our team to schedule a demo.
