Modern Document Control for Life Sciences.
A secure, Part 11-ready document management system built specifically for regulated teams.
iQuality DX is the foundation of a unified compliance platform.
Why Modernize Document Control?
Document Control Is Not File Storage. It's Regulated Evidence.
Regulatory expectations continue to rise
Manual routing introduces risk
Legacy systems create friction and audit stress
Modern document control should be
Secure and cloud-native
Enterprise-grade infrastructure with encryption at rest and in transit.
Audit-ready by design
Every action logged, every trail preserved automatically.
Structured and traceable
Version-controlled documents with full lifecycle visibility.
Intuitive for regulated teams
Designed for compliance professionals, not IT specialists.
Q Insight
iQuality DX was built to meet today's compliance requirements, not yesterday's.
Modern document control. Secure. Compliant. Ready.
Built on the unified iQuality platform architecture, DX establishes a secure, inspection-ready compliance foundation.
iQuality DX transforms documents from static files into controlled, traceable compliance evidence, all within a structured, regulated environment.
No spreadsheets.
No email-based approvals.
No audit scrambling.
No disconnected signature tools.
Q Insight
Controlled documents are only part of compliance. Verified execution completes the evidence trail.
Electronic Signatures Built for Regulated Workflows
iSign is iQuality's integrated electronic signature capability, designed specifically for GxP environments.
Unlike generic signature tools built for contracts, iSign is built for regulated documentation.
iSign Features
No third-party plug-ins.
No dual systems.
No reconciliation gaps.
Q Insight
Electronic signatures should strengthen compliance, not complicate it.
Responsible Innovation by Design
iQuality is developed and operated within an ISO/IEC 42001 certified AI management system
Structured AI governance oversight
Formal oversight processes embedded into development workflows.
Documented risk controls
Every AI-related risk identified, assessed, and mitigated.
Responsible development practices
Ethical considerations baked into every design decision.
Alignment with emerging global AI standards
Proactively meeting international regulatory expectations.
As intelligent validation and quality modules are introduced, governance is already embedded at the foundation.
Compliance does not start when AI launches.Responsible AI doesn't begin at deployment. It begins with design.
Q Insight
The foundation you build today supports the systems you'll need tomorrow.
The iQuality Platform Roadmap
iQuality is building a unified quality and compliance platform designed to support the full lifecycle of regulated operations.
Document Xcellence
Secure document control with iSign integrated iQuality electronic signature.
Validation Xcellence
Validation lifecycle management is designed to modernize validation to bring systems live faster.
Join the Early Access List
We are inviting a limited number of life sciences organizations to preview upcoming modules before public release.
Early access participants will:
If validation modernization or QMS transformation is on your 12 to 18 month roadmap, we would welcome the opportunity to discuss.
Join VX and QX Early AccessQ INVITATION
Preview what's coming next.
Designed for Life Sciences
Purpose-built for organizations where compliance is mission-critical.
Pharmaceutical Companies
Structured document governance across R and D and manufacturing.
Biotech Innovators
Modern document control without legacy complexity.
Medical Device Firms
Structured, Inspection-ready document governance without legacy complexity
Trust First. Always.
Compliance is not overhead. It is the foundation of safety and credibility.
What We Believe
Compliance by Design
Systems should make the right process the easy process.
Clarity Over Complexity
Powerful capability delivered with intuitive structure.
Built for Life Sciences
Designed by professionals who understand regulated environments.
Foundation Before Automation
Strong document control is the backbone of modern quality systems.