Qlutch provides a cloud‑native, modular quality management system that lets regulated organizations activate only the compliance apps they need, such as AI‑driven document control, digital checklists, and low‑code workflow automation. The platform offers role‑based access, API integration with ERP/LIMS/EHR, and a subscription pricing model that reduces total cost of ownership for small and mid‑size labs.
Funding
Funding not disclosed
Founders
Product
Problem
Regulated organizations often rely on legacy Quality Management Systems that are costly, rigid, and require extensive IT overhead, making it difficult for small and mid‑size labs to maintain document control, audit readiness, and compliance with standards such as ISO 9001, ISO 17025, or FDA 21 CFR 820. These systems typically demand manual versioning, complex approval hierarchies, and on‑site implementation, leading to slow change cycles and elevated operational expenses.
Solution
Qlutch delivers a cloud‑native, modular QMS platform that isolates each compliance function into interchangeable SaaS applications, allowing organizations to activate only the tools they need. AI‑enhanced document control automates drafting, revision tracking, and approval routing while preserving a complete, tamper‑evident audit trail. Integrated checklist and inspection modules digitize field audits, capture real‑time data, and generate instant compliance reports. Customizable form and workflow engines enable low‑code process automation, reducing manual data entry and error rates. Role‑based access controls and API endpoints ensure seamless integration with ERP, LIMS, or EHR systems, while a subscription model keeps total cost of ownership predictable. Human‑centered support and a user‑friendly UI minimize training time, enabling quality teams to focus on continuous improvement rather than system administration.
Target Audience
Primary users are quality managers, lab directors, and compliance officers in testing, inspection, certification, life‑science, manufacturing, and other regulated sectors seeking a cost‑effective, scalable QMS solution. The platform also serves small startups and mid‑size enterprises that require rapid deployment without extensive IT resources.
Features
- Secure, cloud‑hosted document repository with automated versioning, AI‑driven content suggestions, and configurable approval workflows.
- Digital checklist and inspection management with real‑time status dashboards and exportable compliance reports.
- Low‑code form builder and workflow engine for end‑to‑end process automation across quality, safety, and regulatory tasks.
- Modular licensing architecture that lets users add or remove QMS apps (Document Management, Inspection, Forms, etc.) on demand.
- Role‑based permissions, full audit trail, and FHIR/ISO‑compliant APIs for integration with existing enterprise systems.
- Built‑in AI analytics that flag policy gaps, suggest corrective actions, and surface trends for proactive risk management.
- Scalable SaaS infrastructure with multi‑tenant isolation, ensuring data integrity and regulatory‑grade security.
- Dedicated human support team offering onboarding assistance and ongoing technical guidance.