GenVault recently earned three new voluntary registrations and accreditations. These classifications meet and exceed all federal and business standards in place for biorepositories.
The GenVault Principle
“Providing truly comprehensive biorepository solutions means never being satisfied with the status quo,” said Heather Olsen, Quality Director 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.”
GenVault has pledged to constantly improve its capabilities. This ensures research and medical client samples are stored in the correct conditions and handled by heavily-trained staff. GenVault recently received three significant classifications, augmenting its already robust list of accreditations, registrations, and compliances. GenVault sought to undergo these rigorous voluntary processes to validate ongoing efforts to exceed industry requirements. These additions are:
- ISO 9001 Registered
This registration is the international standard that lays out requirements for a quality management system (QMS). This standard is used by a wide range of organizations to demonstrate their ability to regularly provide products and services that meet regulatory and customer requirements. For an organization to achieve ISO 9001 registration, it must demonstrate that it follows the ISO 9001 standard guidelines, fulfills its own requirements, maintains documentation, and meets customer, statutory, and regulatory requirements. The intent of this registration is to show consumers the organization is credible because its services and products meet expectations.
- ISO 20387 Accredited
This accreditation is the international standard used to promote confidence in biobanking procedures and institutions. It dictates the quality and technical requirements for the impartiality, competence, and consistent operations of biobanks, as well as all aspects of biobank management, including personnel, facilities, structural, equipment, and process management. The standard also covers quality management systems and every step of sample handling, from collection to distribution. To get certified, the organization must meet and follow every requirement within the standard. ISO 20387 accreditation is regarded as one of the most crucial standards that a biobanking organization can meet.
- CAP Accredited
After a facility acquires Clinical Laboratory Improvement Amendments (CLIA) accreditation, it can pursue a higher accreditation with the College of American Pathologists (CAP). The certificate is administered to laboratory facilities that perform complex, high-proficiency testing requiring significant education, expertise, and training.
Maintaining Standard Requirements
Market growth and capital investment have risen significantly in the research and clinical fields, driving advancement in organizations that work with biological samples. These facilities and laboratories need a place that meets all standard requirements to store the samples that arise from the new studies and experiments. Though GenVault has sought out higher-level, optional accreditations, it still maintains the mandatory conditions biosample storage and transportation organizations must meet.
As a GxP-compliant biorepository, all GenVault’s operating procedures 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 the following:
21 CFR part 11 (electronic records and signatures)
21 CFR part 211 (current good manufacturing practices)
21 CFR part 58 (good laboratory practices)
After meeting all required practices and guidelines, the focus moves toward advancement and relevance to clients working with biosamples. Though GenVault’s facility was built by biorepository professionals, the practices in place could become obsolete if they were not continuously updated.
GenVault is a secure, comprehensive commercial facility for bioinventory storage and transport. GenVault prioritizes space, security, and support for all its clients with six floors of storage and 24/7 monitoring. To substantiate quality, GenVault 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.
GenVault supports the storage of many different types of biosamples in a wide range of customizable storage solutions. Internal and external security features, as well as multiple redundancies, yield maximum protection.
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 the government. GenVault was built to be a state-of-the-art facility that keeps its clients’ samples secure. Protecting the integrity of these samples requires constant evaluation and updating of procedures and designations, especially because they work within the rapidly evolving research and clinical medicine fields.
Request a consult to learn more about the GenVault biorepository storage standards, as well as its lab transport services. The facility is located in West Deptford, NJ.