Unifize – AI Governed Layer for Quality & Document Management
Unifize · Logistics & Supply Chain
Certification per Microsoft Marketplace.
Evidence tier Source Confirmed · 7 captures on record
What the publisher says
As described on Microsoft Marketplace.
Offer Description
Unifize is an AI-governed layer for quality and document management built for regulated industries. It replaces the patchwork of email threads, shared drives, and disconnected tools with a single governed layer where every CAPA, change order, document approval, and audit runs end-to-end, with full traceability, accountability, and AI assistance built in from day one.
Show the rest of the publisher’s description (31 more lines)
Unlike traditional QMS and DMS tools that operate as separate systems with distinct data models, Unifize integrates AI, collaboration, quality management and document control into a single platform and works alongside your existing systems. Every record is linked. Every decision is traceable. When you are ready to expand, PLM, MES, EHS, and CMMS can be deployed on the same layer: no migration, no re-implementation.
Choose your entry point: QMS for quality management or DMS for document and training management.
Key Features:
QMS
- Change control with linked impact assessments, approvals, and full traceability
- CAPA management with collaborative root cause analysis and closure tracking
- Audit management with audit-ready records and corrective action linkage
- Supplier quality with qualification workflows and performance tracking
- Nonconformance management with full traceability to source events
- AI-assisted workflows with Microsoft Copilot
DMS
- Controlled document lifecycle: authoring, review, approval, version control, and distribution
- SOP management with full cross-functional approval workflows
- Training auto-assignment on document update, with completion tracking and records
- Revision control linked to change requests and impact assessments
- SharePoint integration: documents stored in SharePoint, lifecycle governed in Unifize
- 21 CFR Part 11-compliant electronic signatures
Security & Hosting
Hosted on Microsoft Azure. Unifize 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
- MedTech organizations under regulations like FDA 21 CFR Part 820, ISO 13485, or EU MDR
- Pharma and biotech teams under regulations like cGMP, GxP, or 21 CFR Part 11
- Life sciences organizations are replacing legacy or homegrown QMS and DMS systems
- Quality and operations teams that need one system of record across change control, documents, and training
- IT and compliance leaders evaluating validated, audit-ready platforms within the Microsoft stack
Key Benefits
- Shorter CAPA cycles – close investigations faster with structured threads and AI-assisted drafts
- Real-time audit readiness – audit trails are a byproduct of execution, not a separate effort
- Faster change control – approvals, evidence, and traceability in one place, not across email and spreadsheets
- One platform, no re-implementation – expand to DMS, PLM, MES, EHS, or CMMS on the same governed layer
- First value visible within 90 days
Preview
5 images
Agent build and provenance
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Compliance
- FedRAMPConfirmedNot listed90%, registry-checkedNo FedRAMP Marketplace entry matched this vendor's domain, checked 2026-08-27registry recordas observed 2026-08-27
Confirmed means matched to a public authoritative registry. Claimed means the vendor or its listing states it, not yet cross-checked. A framework not shown was not found in any source we hold, which is not evidence against it. Not listed means a scoped registry check found no match for this vendor's domain: a No is a scoped registry check, not a compliance judgment. Confidence bands: 95% domain-verified, 90% registry-checked, 80% self-attested, 70% weak signal. Self-attested items marked “vendor's site” are gathered from the vendor's own website and are not verified by us.
Plans and pricing as listed
2 listedSources
Publisher resources
6 linksLinked repositories
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