Regulatory Intelligence
EU GMP · FDA · ICH · ISO
Platform
One Intelligent Platform. Every Quality Function.
GQMI brings regulatory content, controlled company documentation and user context into a single working environment for quality and compliance teams.
How it works
Three Sources. One Intelligent Answer.
Structured, context-aware guidance aligned with applicable requirements and organizational knowledge.
Company Knowledge
SOPs · Policies · Procedures · Validation documents
User Context
Natural-language questions · Role-specific requirements · Process context · Applicable jurisdictions
Product experience
One Intelligent Platform. Every Quality Function.
Explore how each area of GQMI supports day-to-day quality and compliance work.
AI Quality Workspace
Ask questions, review controlled documents and generate structured quality outputs using organizational knowledge and applicable regulatory sources.
AI Quality Workspace
Natural language
Ask GQMI naturally.
Select an example question to see the structure of an evidence-linked answer.
Illustrative demonstration
How should this deviation be investigated according to EU GMP?
- Finding
- The investigation record does not document a root-cause methodology or a rationale for the batch-impact conclusion.
- Regulatory context
- EU GMP Part I, Chapter 1 (Pharmaceutical Quality System) and ICH Q10 expectations for documented investigation and root-cause analysis.
- Document reference
- SOP-QA-014 “Deviation Management”, Section 6.3 — investigation documentation.
- Risk classification
- Medium — documentation completeness gap, no product impact identified in the reviewed evidence.
- Recommended next step
- Complete the root-cause section using the methodology defined in SOP-QA-014 and record the batch-impact rationale before closure.
- Confidence and source information
- Based on 3 retrieved passages from 2 source documents. Confidence indicators are not guarantees and require review by authorized personnel.
Example content shown for illustration only. Actual output depends on the configured document set and regulatory content, and requires review by authorized personnel.
Coverage
Support Across the Quality Lifecycle
GQMI assists quality teams throughout the processes they already operate — always as decision support for qualified professionals.
Quality Management Systems
Provides structured guidance on QMS elements and their documented expectations.
Electronic QMS
Assists teams working alongside eQMS records by organizing related knowledge and context.
Deviations
Supports investigation structure, questioning and documentation completeness reviews.
CAPA
Helps teams draft structured corrective and preventive action plans for professional review.
Change Control
Assists with impact considerations and identification of affected documents and processes.
Quality Risk Management
Provides structured support for risk questions aligned with recognized frameworks.
Audit Management
Helps prepare audit agendas, topic lists and supporting evidence overviews.
Supplier Quality
Supports review of supplier documentation and qualification-related questions.
Complaint Management
Assists with structured complaint assessment and follow-up documentation drafts.
Validation
Enables faster access to validation evidence, protocols and related requirements.
CSV and CSA
Provides structured guidance on computerized system assurance considerations.
Training
Helps teams locate role-relevant procedures and build training-support material.
Regulatory Intelligence
Enables faster access to applicable regulations, guidance and standards.
Inspection Readiness
Supports preparation with structured question sets and evidence overviews.
Batch Record Review
Assists with comparison of records against approved master documentation.
Management Review
Helps compile structured inputs for periodic management review meetings.
KPI Analysis
Supports interpretation of quality indicators your organization already maintains.
Knowledge Management
Organizes organizational quality knowledge so it can be retrieved in context.
Continuous Improvement
Supports identification of recurring themes across quality records.
Why GQMI
From Compliance Workload to Quality Intelligence
- Purpose-built for regulated-industry workflows
- Combines regulatory and organizational knowledge
- Context-aware natural-language interaction
- Structured and evidence-focused outputs
- Supports global regulatory frameworks
- Designed for enterprise deployment
- Promotes consistent quality decision support
- Helps reduce repetitive administrative work
- Supports organizational learning and continuous improvement
Turn Quality Knowledge Into Better-Informed Decisions
Discover how GQMI can support regulatory intelligence, document review, inspection readiness and quality decision-making across your organization.
GQMI™ — Transforming Quality. Empowering Compliance. Driving Excellence.