Quality Assurance & Compliance

Accreditations that back our promise of integrity and safety.

Trusted standards. Proven compliance. Complete confidence.

At GenVault, quality is more than a requirement. It is the foundation of everything we do. Our processes, facilities, and systems are designed to meet the highest industry standards, ensuring the integrity, security, and compliance of every material we store.

We operate in full GxP compliance, aligning our practices with internationally recognized guidelines including ISBER, WHO, and ISPE.

Our operations are 21 CFR Part 11 and ALCOA+ compliant to ensure that all electronic records and signatures meet federal standards for integrity, traceability, and audit readiness.
We align with applicable USP standards to reduce variability, mitigate risks associated with sample degradation, and ensure regulatory compliance
We are registered with the FDA as a Third-Party Logistics Provider (3PL) and a Human Cell and Tissue Establishment (HCT/P establishment), meeting DSCSA and HCT/P regulatory requirements for the storage and handling of Finished Good Drug Product and human tissue materials.

Compliance & Accreditation Playbook

Discover how GenVault’s Quality management system, which is based on and certified to the requirements of ISO 9001:2015, supports regulatory readiness across the full sample lifecycle.

Our Certifications and Accreditations

These recognitions reflect our unwavering commitment to excellence as a biorepository and our dedication to maintaining the trust of our clients. Every protocol, every safeguard, and every audit is part of our mission to deliver the highest quality services with complete regulatory compliance.

CAP Accreditation

The College of American Pathologists (CAP) holds rigorous accreditation standards for biorepositories. We hold a Biorepository Accreditation, demonstrating compliance with the highest standards for specimen storage and an unwavering commitment to quality.

ISO 9001 System Certification

ISO 9001 defines requirements for a Quality Management System (QMS) focused on continuous improvement and customer satisfaction. This certification demonstrates our commitment to meeting the needs of our customers.

ISO 20387 Accreditation

We hold an ISO 20387 biobanking accreditation issued by the American Association of Laboratory Accreditation. This standard ensures the competence and consistent operation of biorepositories. This program covers the entire lifecycle of biological material, including collection, preservation, and distribution with an emphasis on enhancing research quality and data reproducibility.

FAQs About Biorepository Quality Assurance and Compliance

Which regulatory guidelines do GenVault's operations follow?

We operate in full GxP compliance and align our practices with internationally recognized guidelines including ISBER, WHO, ISPE, USP, DSCSA, and HCT/P regulatory requirements covering the storage and handling of both finished drug products and human tissue materials.

How does GenVault ensure the ongoing integrity of stored materials?

Every protocol, safeguard, and audit is built into our operational framework. From facility design to chain-of-custody documentation, our processes are engineered to protect material and sample integrity and maintain continuous regulatory compliance.

Can GenVault support clients who are subject to regulatory audits?

Absolutely. Our comprehensive documentation, validated systems, and established compliance frameworks are designed to support client audits with confidence. We provide the records, data, and operational transparency needed to satisfy even the most rigorous regulatory scrutiny.