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ValQMS Tools
AI Risk Assessment (GAMP 5 / ICH Q9)
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System Info
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Technical
3
Compliance
4
Operations
🎯 System Information
System Name
System Type
LIMS (Laboratory Information Management)
ERP (Enterprise Resource Planning)
MES (Manufacturing Execution System)
QMS (Quality Management System)
EDMS (Electronic Document Management)
CDS (Chromatography Data System)
ELN (Electronic Lab Notebook)
Custom Application
System Category (GAMP 5)
Category 1: Infrastructure Software (OS, Database)
Category 3: Non-configured Product (COTS)
Category 4: Configured Product
Category 5: Custom Application
Deployment Model
On-Premise
Cloud (SaaS)
Hybrid
Validated Cloud (AWS/Azure GxP)
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⚙️ Technical Assessment
System Complexity
Simple - Basic CRUD, minimal business logic
Moderate - Business logic, some integrations
Complex - Advanced workflows, multiple integrations
Very Complex - AI/ML, real-time processing, critical algorithms
Number of Integrations
0 - Standalone system
1-3 - Few integrations
4-7 - Multiple integrations
8+ - Highly integrated
Data Volume
Low - < 1GB, < 1000 records/day
Medium - 1-100GB, 1K-10K records/day
High - 100GB-1TB, 10K-100K records/day
Very High - > 1TB, > 100K records/day
System Maturity
New/Prototype - First deployment
Developing - Early versions, frequent changes
Mature - Established, stable releases
Legacy - Old technology, maintenance mode
Vendor Support Quality
Poor - Limited support, slow response
Fair - Basic support available
Good - Responsive, documented processes
Excellent - 24/7 support, GxP expertise
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📋 Compliance & Regulatory
Does System Handle GxP Data?
No - Non-GxP system
Yes - GxP critical data
Regulatory Scope
FDA (US) Only
EMA (EU) Only
FDA + EMA (Global)
MHRA (UK)
Multiple Regions (FDA, EMA, PMDA, etc.)
Electronic Signatures (21 CFR Part 11)
No
Yes
Audit Trail Requirements
No audit trail required
Basic - Create/Update/Delete logging
Comprehensive - All data changes tracked
Advanced - Real-time monitoring, tamper-proof
Data Integrity Risk (ALCOA+)
Low - Minimal DI concerns
Medium - Standard DI controls needed
High - Critical DI controls, inspection history
Patient Safety Impact
None - No direct patient impact
Indirect - Supply chain, quality data
Direct - Clinical data, batch release
Critical - Life-saving drug manufacturing
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🏢 Operational Factors
Business Impact if System Fails
Low - Minor inconvenience, workarounds available
Medium - Significant disruption, delays possible
High - Critical operations stop, revenue loss
Catastrophic - Patient safety risk, regulatory action
Number of Users
1-10 users
11-50 users
51-200 users
200+ users
Geographic Distribution
Single site
Multiple sites (same region)
Global (multiple regions)
Change Frequency
Rare - < 1 change per year
Low - 1-4 changes per year
Moderate - 5-12 changes per year
High - Monthly or more frequent changes
Historical Issues
No known issues
Minor issues, resolved quickly
Moderate issues, some downtime
Major issues, FDA observations, recalls
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