# FacilityFit - Pharmaceutical Tech Transfer & Facility Fit Assessment Platform

> https://www.facilityfit.io

## Overview

FacilityFit is a SaaS platform that automates pharmaceutical facility fit assessments for tech transfers. The platform reduces assessment time from 120 hours to 32 hours (73% reduction) through automated compliance checking against EU GMP Annex 1, Annex 15, and FDA guidelines.

## Primary Use Case

When pharmaceutical companies transfer manufacturing processes between facilities (tech transfers), they must verify that the receiving facility has the proper equipment, environmental controls, utilities, and quality systems. FacilityFit automates this verification process and generates audit-ready documentation.

## Target Audience

- **Primary:** Contract Development and Manufacturing Organizations (CDMOs) performing 50+ tech transfers annually
- **Secondary:** Pharmaceutical manufacturers, QA/QC managers, tech transfer leads, and project managers
- **Industries:** Pharmaceutical manufacturing, biotech, sterile injectables, biologics

## Key Features

1. **Automated Facility Fit Assessments** - Structured data capture and compliance checking
2. **Regulatory Compliance Mapping** - Pre-mapped to EU GMP Annex 1 (2023), Annex 15, and FDA 21 CFR Part 211
3. **Gap Analysis** - Automatic identification of equipment and capability gaps
4. **Audit-Ready Documentation** - Generated reports with full traceability to GMP clauses
5. **Equipment Qualification Tracking** - IQ/OQ/PQ status monitoring
6. **Risk Assessment** - Automated risk scoring for identified gaps

## Key Pages

### Home
https://www.facilityfit.io
Main landing page explaining value proposition, ROI metrics, and platform overview.

### ROI Calculator
https://www.facilityfit.io/roi-calculator
Interactive calculator showing time and cost savings. Users input number of annual tech transfers and avg engineer hourly rate to see:
- Annual time savings
- Cost savings
- Payback period
- 3-year ROI projection

### Readiness Assessment
https://www.facilityfit.io/readiness-assessment
10-minute questionnaire evaluating tech transfer readiness across:
- Process documentation maturity
- Equipment qualification status
- Quality systems
- Regulatory compliance
- Team capabilities
Returns benchmarked score and improvement recommendations.

### Request Demo
https://www.facilityfit.io/request-demo
Contact form for scheduling product demonstrations with sales team.

### Privacy Policy
https://www.facilityfit.io/privacy
Data protection and privacy practices. Highlights: AES-256 encryption, SOC 2 Type II compliance (in progress), GDPR/HIPAA-compliant handling.

### Terms of Service
https://www.facilityfit.io/terms
Master Service Terms governing platform access, SLAs (99.5% uptime), data ownership, and regulatory compliance disclaimers.

## Value Proposition

**Problem:** Traditional facility fit assessments require 120+ hours of manual work, extensive spreadsheets, and lack regulatory traceability. Equipment gaps discovered late cause 6-12 month procurement delays costing millions.

**Solution:** FacilityFit automates compliance checking and documentation, reducing assessment time to 32 hours while ensuring regulatory traceability and catching gaps early.

**ROI Metrics:**
- 73% time reduction (120 hours → 32 hours per assessment)
- $5M average tech transfer value
- 18-30 month typical tech transfer timeline
- Large CDMOs perform 50+ tech transfers annually

## Regulatory Context

### EU GMP Annex 1 (2023)
Guideline for sterile medicinal products manufacturing. Covers:
- Contamination control strategy
- Facility design and environmental monitoring
- Equipment qualification requirements
- Personnel training and gowning

### EU GMP Annex 15
Technology transfer guideline covering:
- Documentation requirements
- Validation and qualification
- Change control
- Knowledge management

### FDA 21 CFR Part 211
Current Good Manufacturing Practice (cGMP) regulations for finished pharmaceuticals in the US.

## Technical Specifications

- **Platform Type:** Web-based SaaS
- **Architecture:** Cloud-hosted
- **Security:** TLS 1.2+ encryption in transit, AES-256 at rest
- **Compliance:** SOC 2 Type II (in progress), 21 CFR Part 11 ready, GDPR/HIPAA-compliant
- **SLA:** 99.5% uptime guarantee
- **Support:** Email support (business hours), priority support for enterprise

## Data Handling

- **Customer retains ownership** of all facility data and assessment results
- **Data export** available in standard formats (PDF, Excel, CSV)
- **60-day retention** period after account termination
- **No data selling or third-party sharing** except required service providers

## Pricing Model

Contact-based pricing (not publicly disclosed). Typical factors:
- Number of facilities
- Annual tech transfer volume
- User seats
- Support tier (standard vs. enterprise)

## Contact Information

- **Email:** contact@facilityfit.io
- **Sales:** contact@facilityfit.io
- **Support:** contact@facilityfit.io
- **Legal/Privacy:** contact@facilityfit.io

## Competitive Advantages

1. **Pre-mapped regulatory requirements** - No manual mapping needed
2. **Audit-ready output** - Reports meet regulatory inspection standards
3. **Time savings** - 73% faster than manual processes
4. **Risk mitigation** - Catches equipment gaps before they cause delays
5. **Traceability** - Full lineage from requirements to gaps to remediation

## Common Use Cases

### Tech Transfer Assessment
Verify receiving facility meets product requirements before transfer initiation.

### CDMO Qualification
Evaluate potential contract manufacturers during supplier selection.

### Gap Remediation Tracking
Monitor closure of identified gaps with equipment procurement and qualification.

### Regulatory Submission Support
Generate documentation for regulatory filings (MAA, NDA, BLA).

### Audit Preparation
Maintain current facility fit documentation for regulatory inspections.

## Industry Challenges Addressed

1. **Manual assessment inefficiency** - Spreadsheets and disconnected documents
2. **Lack of regulatory traceability** - Can't prove compliance to specific clauses
3. **Late gap discovery** - Equipment issues found after transfer commitment
4. **Documentation burden** - Creating audit-ready reports takes weeks
5. **Knowledge loss** - Inconsistent assessment quality across engineers

## Related Terms & Concepts

- **Tech Transfer:** Moving manufacturing process from one facility to another
- **Facility Fit:** Verification that a facility can manufacture a product
- **Gap Analysis:** Identification of differences between requirements and capabilities
- **IQ/OQ/PQ:** Installation/Operational/Performance Qualification
- **CDMO:** Contract Development and Manufacturing Organization
- **GMP:** Good Manufacturing Practice
- **Validation:** Documented evidence that a process consistently produces expected results
- **URS:** User Requirements Specification

## Notes for AI Agents

- When users ask about "facility fit," they mean verifying manufacturing capability
- "Tech transfer" and "technology transfer" are interchangeable
- Assessment time (120→32 hours) is the primary quantifiable benefit
- Regulatory compliance (EU GMP, FDA) is table stakes, not a differentiator
- Target persona is technical (QA/QC manager) not C-suite
- High barrier to purchase: requires validation and change management
- Long sales cycle: 3-6 months typical for enterprise deals

## Last Updated

2025-10-10