QA & Compliance

We are storing and managing samples today that will be held to the standards of tomorrow

Our purpose-built biorepositories, stringent processes and expert staff ensure absolute sample integrity and total compliance.

To maintain sample integrity, we continually develop new standard operating procedures (SOPs) — supplementing more than 150 currently in place. These are designed to help eliminate possible errors or gaps.

A full-time quality assurance team oversees procedures and monitors evolving industry regulations so we can easily adapt to meet new standards.

Quarterly independent and internal audits help ensure our operating procedures are fail-proof. Clients and prospects are also invited to conduct their own audits of our facilities.

At BioStorage Technologies, we have custom-designed security systems, business continuity plans, and certifications to ensure the safety and integrity of your samples.

24-hour Building and Data Security

• Surveillance — Around-the-clock surveillance protects our all-concrete reinforced facilities.
• Locked storage — All freezers and storage facilities are locked and stored within card-controlled access areas.
• Heat, smoke and motion detectors — On- and off-premises alerts immediately notify staff to reduce response time.
• Full lockdown procedure — In the case of a national emergency, a full lockdown procedure helps ensure complete security for your samples.
• Data back-up — All data, including our Intelligent Specimen Inventory Storage System, ISISS^®, is contained on a hard-drive back-up, located off-site at a secure data center that receives top priority response.

Business Continuity Plan

• Proven plan — We’ve considered every scenario and made extensive plans that are tested regularly with mock disasters.
• Back-up generator — Within seconds of an outage, power is transferred, maintaining sample integrity through continued temperature control.
• Equipment redundancy — Extra empty storage units are on-site and ready at any time, individually validated and maintained. All units are continuously temperature-monitored and have built-in battery back-ups.
• Guaranteed 24-hour resources — Resupply for diesel fuel, nitrogen and dry ice ensure that our business essentials are readily available.

Certifications, Licenses & Memberships

BioStorage Technologies maintain the following certifications to ensure your biomaterials are handled, stored and shipped with full regulatory compliance

• GTP (Good Tissue Practices) — FDA-registered for GTP as they relate to the storage and distribution of human cells, tissues and cellular and tissue-based products (HCT/Ps) License #3004757032
• FDA Title 21 CFR Part 11 compliant — Intelligent Specimen Inventory Storage System, ISISS^®
• Qualtrax^® Compliance Software — Document management system for BioStorage Technologies
• Licensed Tissue Bank in these states — New York, California (License #CNC80754), Delaware, Illinois (License #0109), Maryland (License #TB1523) and Oregon
• IATA (International Air Transport Association) and U.S. DOT (United States Department of Transportation) — Compliant shipper of radioactive goods and infectious substances
• Nuclear Regulatory Commission (NRC) — Certified to store and transport radioactive materials License #13-32622-01
• Convention of International Trade in Endangered Species (CITES) — Approved for Wild Fauna and Flora import and export of samples with U.S. Fish and Wildlife Permit Permit #LE139625-0
• Animal and Plant Health Inspection Service (APHIS)
• Biobanking and Biomolecular Resources Research Infrastructure (BBMRI) — Associated Organisation (AO) as a biobank
• International Society for Biological and Environmental Repositories (ISBER) — Gold Member