Pharmaceutical Facility Fit Assessment Software
Structured compliance checking for equipment specifications, facility capabilities, and regulatory requirements. Generate audit-ready gap registers with full traceability to GMP clauses.
Your Tech Transfer Assessments
Shouldn't Take 6 Weeks
Large CDMOs perform 50+ tech transfers annually. At $5M and 18-30 months each, facility fit bottlenecks cost millions in delays. Automated facility fit assessment catches equipment gaps before they become 6-12 month procurement delays.
0%
of tech transfers experience quality problems from facility fit gaps¹
0M+
cost per tech transfer (18-30 months)²
0months
equipment procurement delays when gaps identified late³
0%
annual CDMO market growth to $465B by 2032⁴
Drag & drop files
Equipment_List_Site_C.xlsx
42 items · 2.4 MB
Room_Classifications.pdf
8 specs · 1.1 MB
HVAC_Specifications.pdf
Upload Facility Data
Import equipment specs, room classifications, and utility parameters from your existing documentation. FacilityFit automatically parses Excel, PDF, and CSV files to extract critical data points.
- ✓Supports multiple file formats (Excel, PDF, CSV)
- ✓Intelligent parsing extracts equipment specifications automatically
- ✓Real-time validation ensures data quality before mapping
Automated Regulatory Mapping
Our assistant engine automatically matches your equipment specifications against 127+ regulatory clauses from EU GMP Annex 1 and FDA guidelines, identifying gaps with confidence scoring.
- ✓Pre-mapped to EU GMP Annex 1 (2023) and FDA guidance
- ✓Intelligent gap detection with severity scoring
- ✓Real-time progress tracking with estimated completion
42 items
Laminar Flow Hood LAF-204
§4.12 · 98%
✅ Compliant
Autoclave AC-101
§4.18 · 95%
⚠️ Gap detected
🔄 Clean Room CR-A
Analyzing...
33 of 42 mapped · 3 gaps · 45s remaining
Assessment Summary
78%🔴 Autoclave AC-101
In ProgressTemp: 132°C (Req: 134°C)
M. Torres · Oct 15
💬 2 · 📎 Quote
⚠️ Cold Storage CS-305
ReviewRange: ±2.5°C (Spec: ±2°C)
S. Chen · Oct 10
ℹ️ SOP-VAL-204
✅ DoneMissing reference update
👥 3 active · Updated 5m ago
Review & Collaborate on Gaps
Your team reviews identified gaps together, assigns mitigation tasks, and tracks resolution progress. Full audit trail ensures regulatory compliance at every step.
- ✓Severity-based prioritization (Critical, Moderate, Minor)
- ✓Task assignment with due dates and owner tracking
- ✓Real-time collaboration with comments and attachments
Generate Compliance Report
One-click export generates an audit-ready facility fit assessment report with complete regulatory traceability, gap register, and mitigation plans—ready for QA review and signature.
- ✓48-page comprehensive report generated in under 1 minute
- ✓Includes gap register, equipment specs, and audit trail
- ✓Electronic signature support for QA approval workflow
Configuration
FACILITY FIT ASSESSMENT
Site B → Site C Transfer
Oct 2, 2025
1. EXECUTIVE SUMMARY
Assessment conducted...
2. REGULATORY FRAMEWORK
• EU GMP Annex 1 (2023)
3. GAP REGISTER
[Table showing gaps]
📊 48 pages · Ready for QA
✓ Generated in 42 seconds
Ready to Accelerate Your Tech Transfers?
Join leading CDMOs and pharmaceutical manufacturers who are reducing facility fit assessment time from weeks to hours with FacilityFit's automated compliance platform.