Page History
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Pharma & Life Sciences
FDA 21 CFR Part 11 Compliant Automation
FrameworX delivers validated solutions for pharmaceutical
manufacturing with complete audit trails and electronic signatures.
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Key Capabilities
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- FDA 21 CFR Part 11 compliance features
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- Electronic signatures and audit trails
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- Clean room environmental monitoring
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- Validated system templates
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Solution Examples
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HIKMA PHARMACEUTICALS
Replaced closed Honeywell chart recorders
FDA 21 CFR Part 11 compliance achieved
Open data access for reporting
[View Online] [Download PDF]
"Enhanced trending functions with flexible security"
- Hikma Pharmaceuticals
CLEAN ROOM MONITORING BLUEPRINT
Environmental parameter tracking
Particle counting integration
Alarm and deviation management
[View Details →]
BATCH RECORD BLUEPRINT
Electronic batch records
Material tracking and genealogy
Quality parameter monitoring
[View Details →]
EQUIPMENT VALIDATION BLUEPRINT
IQ/OQ/PQ documentation templates
Change control procedures
21 CFR Part 11 assessment
[View Details →]
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Common Applications
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- Clean room monitoring
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- Batch manufacturing
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- Equipment validation
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- Laboratory systems
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- Clinical trial data
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- Cold chain monitoring
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Bottom CTAs
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[Schedule Pharma Consultation] [Download FDA Compliance Guide]
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Use Cases
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