Platform — The Foundations Under Every DnXT Product
The foundations under every product
What IT, security and quality teams want to know: where DnXT runs, how customer data is kept apart, how access is decided, what is recorded, and how regional rules and AI are governed.
Security and compliance
Hosting
Hosted on SOC 2 Type II certified Microsoft Azure infrastructure. Traffic encrypted; sessions time out.
Security →Customer data separation
Each customer’s data is held in its own database — separation is structural, not a filter.
Data separation →Single sign-on and access
Microsoft Entra ID or Okta sign-in; access denied by default and granted per role and per dossier.
Security and SSO →Audit trail
Who did what and when, recorded across the products and available for inspection.
Audit trail →Electronic signatures
Signer, time and meaning recorded, for internal and external signers.
eSignature →Validation support
Requirements, risk and test evidence to support your computer system validation.
Validation guide →Shared capabilities
Regional rules
Module 1, vocabularies and validation criteria for 16 eCTD regions — more than 2,500 criteria.
Regions →Search
Keyword and meaning-based search, filtered by each user’s access on every query.
Search →AI gateway
Every AI feature through one gateway: provider per customer, features enabled individually, usage limits.
AI gateway →Workflow
Configurable review and approval routes with signatures at each step.
Workflow →Integrations
Veeva Vault, SharePoint, Box and Egnyte as document sources.
Integrations →Document checks
PDF properties, fonts, bookmarks and links checked where documents are created and approved.
Document QC →Frequently asked
Does DnXT hold its own SOC 2 report?
DnXT is hosted on SOC 2 Type II certified Microsoft Azure infrastructure.
How is our data kept apart from other customers?
Each customer’s data is held in its own database.
Bring your IT and quality questions
We will walk your teams through the foundations, in the product.