Quality
Quality Management Systems
Built for Trust. Proven by Process.
Regulatory Compliance & Quality Assurance
At CellSecure Bio, quality is the foundation of everything we do; it is part of our culture. We operate under a comprehensive Quality Management System (QMS) supported by documented processes, procedures, and responsibilities. These systems ensure consistency, traceability, and regulatory compliance, providing confidence to clients operating in regulated environments.
Quality Systems That Support Regulatory Compliance
Protecting biological materials and cellular therapies requires more than maintaining temperature. Our quality management system is designed to support consistent operations, traceability, and documented processes throughout every stage of storage.
Our quality program includes:
- Standard operating procedures (SOPs)
- Equipment qualification and validation
- Continuous environmental monitoring
- Calibration and preventive maintenance
- Chain of custody documentation
- Electronic inventory tracking
- Deviation management and corrective actions
- Staff training and competency programs
- Comprehensive documentation and record retention
Reliable Solutions
Quality Assurance Process
Event Detection
Any deviation or issue is identified through continuous monitoring and routine checks.
Investigation & Evaluation
Our quality team assesses the root cause analysis to understand the problem.
Corrective Actions
Corrective actions are implemented, and preventive measures are defined to prevent recurrence (CAPA).
Documentation & Traceability
All events, investigations, and actions are fully documented for accountability and compliance.
Verification & Review
Post-action review ensures effectiveness and confirms material integrity is maintained.
Preventive Action
Redundancy in critical systems, chain-of-custody procedures, and mandatory training policies is in place as part of preventive action.
Licenses, accreditations & Registrations
We seek and secure the required regulatory licenses, accreditations, and registrations for our services, demonstrating our commitment to quality, compliance, and industry standards.
FDA
Our facility is registered with the US FDA and complies with all regulations to ensure that the storage and handling of clinical biological materials meet federal safety and quality standards.
ISO – International Organization for Standardization
Our ISO certification demonstrates our dedication to maintaining a robust quality management system to meet customer and regulatory requirements, delivering safe, reliable, and high-quality services.
cGMP
We maintain cGMP-compliant storage environments and follow established procedures for chain of custody, quality assurance, documentation, inventory management, personnel training, and equipment validation (IQ/OQ). This ensures stability, traceability, and identity of all biological materials stored at CellSecure Bio.
State of Illinois Tissue Banking and Transplant
We are registered with the State of Illinois Department of Public Health Services. We comply with all Illinois tissue banking and transplant regulations. All human tissue and related materials are stored and managed safely and legally.
FACT Accreditation
Our biorepository supports programs seeking FACT accreditation and adheres to high standards for cellular therapy and tissue storage. This ensures safe, quality-assured handling of cell and tissue-based materials.
Our cell storage methods are consistent with the FACT guidelines and follow all mandatory requirements listed in the latest edition of the FACT accreditation manual.
Audits & Documentation
Our team works closely with client QA and regulatory groups to streamline reviews and ensure confidence in our processes.
Testimonials
What Our Customers Say
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