Quality Inspection & CAPA Management
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Pharmaceutical Compliance Guide
Key Quality Challenges
Time-consuming Quality Inspections
Impact: Production bottlenecks and human error variability in visual inspection.
Inconsistent Deviation Identification
Impact: Reactive quality management and recurring issues that should have been prevented.
Manual CAPA Processes
Impact: Slow root cause analysis, ineffective corrective actions, and repeat deviations.
Scattered Laboratory Data
Impact: Lab data across instruments and paper records makes trend analysis difficult.
Quality Inspection Automation
Computer Vision for Consistent Quality
Visual inspection of tablets, vials, and packaging relies on subjective human judgment and is prone to fatigue. Inspectors working long shifts experience decreased accuracy, leading to inconsistent defect detection and quality escapes.
Our computer vision solution provides 24/7 automated inspection without fatigue. Quality images and inspection records are stored through our digitization services, creating a complete visual quality history for each batch.
- Computer vision checks for defects (cracks, color variations, fill levels)
- Real-time defect detection and automatic categorization
- 24/7 automated visual inspection without fatigue
- Consistent quality standards application across all batches
- Detailed defect trending data and analytics
- Integration with production line systems
Inspection Impact
Consistent detection across all inspection points
24/7 automated inspection without performance degradation
Analytics for continuous quality improvement
CAPA Intelligence
AI identifies patterns humans miss
Automated summarization and root cause suggestions
Stronger inspection readiness for regulatory bodies
CAPA Management Intelligence
GenAI-Powered Deviation & CAPA
Recurring deviations across similar equipment types were not easily correlated, leading to ineffective root cause analysis. Manual CAPA processes meant investigators spent hours gathering data instead of analyzing problems.
Our deviation management integrates with our records management system to provide complete traceability from deviation to resolution, with all supporting evidence securely stored and easily retrievable for audits.
- AI-assisted deviation intake and auto-classification (Critical/Major/Minor)
- Raise deviation against SOP/STP with evidence and photo attachments
- Generative AI analysis of deviation patterns across batches
- AI-suggested root cause analysis based on historical data
- Automated tracking of CAPA closure with effectiveness monitoring
- Trend analysis across product lines and equipment types
- Root cause tracking with approval/closure workflow
Laboratory Data Management
Intelligent Lab Data Integration
Lab data scattered across instruments and paper records makes trend analysis difficult. OOS investigations take days because investigators must manually gather data from multiple sources.
- Intelligent extraction from LIMS and laboratory instruments
- Automated OOS (Out of Specification) flagging and alerts
- Real-time trend monitoring across test parameters
- Paperless lab operations integration
- Full data traceability from sample to result
Key Benefits
- Faster OOS investigations with centralized data
- Full data traceability from sample to result
- Improved lab efficiency with paperless operations
QMS Integration
Quality Management System Backbone
Our quality solutions form the document backbone of your Quality Management System, feeding other QMS modules (CAPA, audit, training) with controlled documents. This helps pharma firms align with ISO 9001, ISO 27001, and FDA 21 CFR Part 11 requirements.
- Document control integration for controlled documents
- Change control integration for process changes
- Training records management and compliance tracking
- CAPA tracking support with effectiveness monitoring
- Audit tracking and findings management
Reports & Dashboards
- Document status reports and pending approvals
- Deviation and change control metrics
- Version histories and compliance dashboards
Quality & Compliance Framework
Our quality solutions meet the stringent requirements of pharmaceutical regulatory bodies worldwide
Electronic Records & Signatures
Good Manufacturing Practices
Data Integrity Principles
Quality Management Systems
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