- ISO 9001 certification
- ISO 20387 certification
- CAP accreditation
GenVault sought to undergo the rigorous voluntary certifications to validate ongoing efforts to exceed industry requirements as a demonstration of commitment to consistent quality assurance and integrity of clients’ biological samples and the highest level of customer service and satisfaction.
“Providing truly comprehensive biorepository solutions means never being satisfied with the status quo,” said Keith DiMarino, CEO of GenVault. “We know that the biological samples and products entrusted in our care for storage or transport are irreplaceable, their value immeasurable, so they deserve the most stringent measures we can take to protect them.”
A GxP-compliance biorepository, all GenVault’s operating procedures fully follow FDA and other required standards and practices, such as GLP, GMP, GDP, and ISBER. Its custom Quality Management System (QMS) is in compliance with:
- 21 CFR part 11 (electronic records and signatures)
- 21 CFR part 211 (current good manufacturing practices)
- 21 CFR part 58 (good laboratory practices)
GenVault also offers an in-depth audit of its processes and documented procedures to clients before they choose to work with the company.
“As a transparent and trusted partner to our clients, we want them to see the extent of the measures GenVault puts in place to control and be accountable for preserving their precious assets that may one day lead to life-saving discoveries,” said scientist Emily Young, executive director at GenVault.
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GenVault is one of the nation’s most secure, comprehensive commercial biorepositories. Located in West Deptford, NJ, it shares a half-million square foot purpose-built campus with its sister facility DocuVault, which opened in 2002 as the region’s only facility specifically designed and built for records management. GenVault stores and transports large collections of biological materials, laboratory chemicals, infectious and non-infectious materials, and high-value equipment for academic research institutes, pharma companies, biotech, and government.