Quality & Compliance · For manufacturers

Vedashwa QMS

One of very few quality systems with design control and post-market surveillance together — 30+ modules built for audited environments.

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A quality-control scientist handling samples in a regulated manufacturing lab

Four pillars, one system

Everything below is live today, from a single multi-tenant codebase.

Quality Core

Live

The everyday quality system

  • Document Control (SOPs, versioning, approval workflows)
  • CAPA — corrective & preventive actions
  • Nonconformance & incidents
  • Complaints handling
  • Change management
  • Audit management (internal & external)
  • Training records
  • Electronic signatures & tamper-evident audit logs

Design Control

Live

ISO 13485 §7.3 · 21 CFR 820.30

  • Design projects (DHF)
  • Design inputs
  • Design outputs
  • Design verifications
  • Design validations

Supplier & Risk

Live

ISO 14971 risk management

  • Supplier quality management
  • Risk file (hazards → controls → verification)
  • Risk-control verification links

Clinical & Post-Market

Live

EU MDR post-market · UDI / traceability

  • Post-market surveillance, surveys & analytics
  • Recalls
  • Clinical studies, subjects & case report forms
  • Devices, products & batches (UDI / traceability)

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Chatbot coming soon

Cortex already reads your quality data to answer questions with provenance, and an in-app Cortex assistant is coming to QMS — ask your records in plain English, cited.

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See Vedashwa QMS in action

A walkthrough of the quality management workflow

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