Unifize Document Management System (DMS)
作者 Unifize
Centralized document control and training for FDA/ISO compliance.
Unifize DMS is a modern, AI-powered Document Management System built for FDA- and ISO-regulated companies. It centralizes your controlled documents, automates revisions, and embeds collaboration in every step, transforming how your teams manage, review, and train on documents.
Unlike legacy tools or file storage systems, Unifize DMS doesn’t stop at storing documents. It connects your people, processes, and data in real-time, enabling visibility, accountability, and compliance across the lifecycle of a document, from inception to obsolescence.
Key Features:
Granular Document Control: Create, upload, and manage SOPs, specs, and work instructions with versioning, approvals, and audit trails.
Integrated Training Management: Assign training on approved revisions and track completion with real-time dashboards.
Change Management: Automatically create draft revisions, link impact assessments, and streamline approvals.
SharePoint & Office 365 Integration: Edit and collaborate in real-time using tools you already use, without losing control or traceability.
CFR Part 11 Compliance: Includes secure, timestamped e-signatures with role-based access and full traceability.
Security & Hosting:
Hosted on Microsoft Azure with SOC 2 Type II compliance, Unifize supports SSO, GovCloud deployments, and robust access control to meet stringent enterprise and regulatory requirements.
Modular Capabilities within DMS:
Document Control: Full lifecycle management from creation to obsolescence—with versioning, approvals, audit trails, and secure access.
Change Management: Drive controlled updates with built-in impact analysis, draft revisions, linked records, and compliant approvals.
Training Management: Assign, track, and verify training on approved content with real-time dashboards and automated completion logs.
Ideal For:
Quality, Compliance, and Training Teams in FDA/ISO-regulated industries
Medical Devices, Pharma, Nutraceuticals, Cosmetics, Biotech, Manufacturing
Key Benefits:
Reduce audit prep from weeks to days
Automate revision cycles and eliminate bottlenecks
Onboard new employees faster with pre-linked training
Deploy in weeks—not months—with no-code configurability