Quality Assurance, Specimen Safety and Data Security

KamTek’s Quality Management System (QMS) guides our operations across biorepository management, laboratory services, logistics, and IT infrastructure. Our quality systems are structured around:

• FDA’s cGMP and GLP guidelines (21 CFR Part 211)
• ISO 9001:2015 aligned Quality Practices
• 21 CFR Part 11 compliant electronic records and signatures
• ISBER & NCI Best Practices for biorepositories
• NIST-traceable calibration standards.
• HIPAA, OSHA, EPA, and USDA safety standards

Highlights:

• 80+ SOPs across biorepository, lab, and cell culture
• 100+ QA/QC logs, forms, and worksheets
• Daily to annual QA/QC inspections, Incident Reporting, CAPAs, Vendor Qualifications, training programs and more
• Independent QA team reporting directly to executive leadership

KamTek is powered by trained experts:

• PhD-level directors, QA managers, and biosafety officers
• Technicians certified in SOPs, cGMP, and emergency response
• Annual training with job-specific SOP recertification on version changes
• 24/7 on-call personnel for immediate alarm or system response

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KamTek ensures zero downtime for biospecimen safety.

Power Continuity:

• 300-kW backup diesel generator (96-hour autonomy) with Automatic Transfer Switch (ATS)
• Dual diesel tanks (300-gallons & 500-gallons)
• Weekly and biannual tests and fuel inspections
• Instant real time alerts to staff on power failure and generator activation

Environmental Redundancy:

• 7 HVAC units with redundant compressors providing 80 tons of cooling
• Redundant compressors in walk in cold rooms
• Instant real time alerts to staff on non-optimal temperatures

Storage unit Backups:

• At least 10% of storage units are backups.
• 3000 gallon LN2 bulk supply tank always maintained at 60% of its capacity

KamTek has a proven disaster preparedness plan tested in real emergencies (e.g. Hurricane Sandy). We activate full checklists during weather alerts:

• Emergency contact networks
• Generator and ATS (Automatic Transfer Switch) test
• Fuel level inspections
• Dry ice and shipping materials on standby
• Alternate freezer capacity for emergency transfers
• Weekly readiness drills, system tests, and full execution checklists

Backup systems support all cryo-storage, communications, and monitoring functions even during power or internet outages. Every scenario is covered, every second counts.

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Access Control:

• Dual employee authentication for entry (Key Card + Password)
• Monthly audits of access logs
• Stringent visitor and vendor access protocols

Surveillance:

• 24/7 monitoring dome sirens, glass-break, freeze, flood, motion and contact sensors
• 24/7 monitoring motion enabled AI 4K cameras
• Intrusion detection with real-time alerts and law enforcement integration
• Panic buttons throughout the facility

Emergency Alerts:

• Monthly system checks and simulations (R-G046)
• Remote access to security systems for immediate response
• 24/7 on call staff for emergency alerts

Every door is logged, every visitor signed in, and every motion tracked. Security simulations are conducted monthly, and only authorized personnel are permitted near samples and sensitive systems.

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KamTek’s digital security strategy safeguards both data and operations:

• Data maintained by ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate)
• 21 CFR Part 11-compliant digital documented data systems
• Controlled access with MFA and restricted privileges
• HIPAA rules for patient data confidentiality
• Security Edge system for threat detection and prevention
• Advanced threat detection against phishing and ransomware
• Documentation

Network &Data:

• Daily full backups of all business data
• Data stored on-cloud with backup on-site and off-site
• Internet failover with 5G GSM redundancy

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