QMS

Offer Description

Unifize QMS is an AI-powered, collaborative Quality Management System built for FDA- and ISO-regulated manufacturers. Designed to eliminate silos, reduce compliance risk, and accelerate quality workflows, Unifize centralizes CAPAs, deviations, audits, complaints, and change controls into a unified, collaborative workspace.

Unlike legacy eQMS tools that are reactive, rigid, and isolated, Unifize enables real-time resolution and continuous improvement by embedding chat, documents, and audit trails directly into every quality workflow. From non-conformance to resolution, every stakeholder operates on the same thread—with AI suggesting root causes, surfacing risks, and helping close the loop faster.

Key Features:

• Corrective and Preventive Actions (CAPA): Manage the full lifecycle—from issue through root cause, action plans, and effectiveness checks—with linked records, traceability, and automated reminders.
  

• Deviations and Non-Conformances: Capture quality events at the source, assign actions, and collaborate with stakeholders in real time to ensure quick resolution.
  

• Change Control: Assess, approve, and implement changes with risk evaluation, linked documents, and automated impact tracking.
  

• Audit Management: Schedule, conduct, and track internal and supplier audits with customizable checklists and real-time follow-ups.
  

• Customer Complaints: Centralized complaint handling with severity assessment, escalation workflows, and integrated CAPA linkage.
  

• Supplier Quality: Monitor supplier performance, manage SCARs, and ensure incoming material compliance.
  

• Integrated Collaboration: Every workflow includes threaded chat, mentions, and file sharing—so decisions are made in context and fully traceable.
  

Security & Hosting

Hosted on Microsoft Azure, Unifize QMS is SOC 2 Type II compliant, supports SSO and GovCloud deployments, and includes 21 CFR Part 11-compliant e-signatures, full audit trails, and role-based access controls .

Ideal For

• Quality, Regulatory, and Operations teams in FDA/ISO-regulated sectors
  

• Medical Devices, Industrial Machinery, Biotech, Nutritional Supplements, Cosmetics, Aerospace and Defence, Automotive, etc.
  

Key Benefits

• Shorten CAPA and NC cycle times by 50–70%

• Prepare for audits in days—not weeks—with real-time traceability

• Eliminate silos by bringing documents, decisions, and actions into one platform

• Deploy and configure in weeks with no-code flexibility