Unifize

Founded 2019

Manage quality events, change orders, and controlled documents across regulated manufacturing teams

Pricing model

Demo

You can use Unifize to manage regulated processes like CAPAs, change orders, and document reviews in one centralized place. It links team conversations directly to official quality records, ensuring that decisions and evidence remain tied together for audit compliance. Teams can track non-conformances, perform root cause investigations, assign containment tasks with specific due dates, and route approvals without chasing updates across separate email threads. The system supports electronic signatures and version controls to help manufacturers meet strict regulatory standards like ISO 13485 and FDA 21 CFR.

What Unifize does

Assign containment actions and track due dates across teamsAttach inspection photos and measurement logs directly to quality ticketsRoute engineering change orders for cross-departmental approvalsConduct root cause investigations using structured 5-Why frameworksCollect electronic signatures for compliance sign-offsUpdate manufacturing part stock status through ERP synchronizationArchive closed quality records with complete audit trailsDiscussion threads linked directly to official quality and compliance recordsAutomated task assignment with visible due dates and handoff trackingElectronic signatures compliant with 21 CFR Part 11 regulationsControlled document management with revision histories and automated retraining tasksRoot cause analysis workflows including 5-Why methodologies and interview recordsIntegration with ERP systems to update stock and lot status upon closureAudit trail logging that captures all reviews, approvals, and supporting evidence