GMP-Compliant Visitor
Management for Pharma
Cleanroom access control, contractor qualification tracking, and FDA-ready audit trails for pharmaceutical and life sciences facilities.
FDA ready · GMP compliant · 21 CFR Part 11
The Problem
Pharmaceutical Visitor Challenges
Manual processes risk FDA violations and compromise product integrity.
FDA & GMP Compliance Risk
Incomplete visitor records and uncontrolled access to production areas put your facility at risk of FDA 483 observations and costly remediation.
Cleanroom Contamination Risk
Visitors entering controlled environments without proper gowning verification or training certification compromise product integrity.
Audit Trail Gaps
Paper-based logs can't provide the detailed, tamper-proof audit trails FDA inspectors expect during facility inspections.
Features
Built for Pharmaceutical Compliance
Purpose-built features for FDA-regulated pharmaceutical and life sciences environments.
GMP Training Verification
Verify that visitors have completed required GMP training before granting access to production or cleanroom areas.
Cleanroom Access Control
Zone-based access ensures visitors are only permitted in areas matching their clearance level. Track gowning compliance automatically.
FDA 21 CFR Part 11 Ready
Electronic records with audit trails, electronic signatures, and access controls designed to meet 21 CFR Part 11 requirements.
Contractor Qualification Tracking
Track contractor certifications, training records, and qualification status. Block check-in for contractors with expired credentials.
NDA & Confidentiality Signing
Require visitors to sign confidentiality agreements and IP protection documents before accessing R&D or manufacturing areas.
Complete Audit Trail
Every visitor interaction is logged with timestamps, zones accessed, and documents signed. Generate FDA-ready reports instantly.
Visitor Type Segregation
Separate check-in flows for auditors, vendors, contractors, and guests with role-appropriate screening and access permissions.
Watchlist & Background Screening
Screen visitors against internal watchlists and debarment databases. Block entry for flagged individuals automatically.
How It Works
Compliant Check-In in 3 Steps
Deploy FDA-ready visitor management for your pharmaceutical facility.
Configure Compliance Policies
Define cleanroom zones, required training certifications, NDA templates, and visitor qualification requirements for each area.
Deploy at Entry Points
Place check-in kiosks at lobby and cleanroom gowning areas. Configure ID scanning, training verification, and document signing.
Audit & Report
Generate FDA-ready audit reports, track contractor qualifications, and maintain 21 CFR Part 11 compliant electronic records.
"Our last FDA inspection went flawlessly. The auditors were impressed with our visitor audit trails and contractor qualification tracking. KyberAccess paid for itself with that single inspection."
Dr. James Liu
Quality Director, NovaBio Pharmaceuticals
Trusted by pharmaceutical companies worldwide
40+
Pharma Facilities
100%
FDA Audit Pass Rate
15K+
Contractors Tracked
99.9%
Uptime
Pharmaceutical Compliance Built In
Meet the strictest pharmaceutical regulatory requirements with purpose-built visitor management.
Everything You Need
Complete visitor management for FDA-regulated facilities.
FAQ
Common Questions
Ready for FDA-compliant visitor management?
Protect your facility, your products, and your compliance record. Start free today.