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Quality Assurance & 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.

Our commitment to quality is maintained through our development of over 150 Standard Operating Procedures (SOPs).

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.

All sample storage units are equipped with ELPRO® temperature monitoring technology. Temperatures are continuously recorded every second and permanently logged every 10 minutes in a US FDA 21 CFR Part 11 compliant uneditable database.

Biorepository Security and Data Protection

  • Security – Our biorepository facilities are custom-designed and purpose built for storing samples. Our facilities are auto-secured by card-controlled access areas which admit only trained and certified staff.
  • Surveillance — Around-the-clock and 24/7 video monitoring system and surveillance procedures protect each of our facilities.
  • Heat, smoke and motion detectors — Fast response times to security alerts sent to the smart phones of our facilities managers.
  • Protected Data Infrastructure — Sample data is stored in an offsite, Category 5 data center which is prioritized for protection by the US government.
  • Data Redundancy — All data within ISIDOR® is backed-up every day and we mirror data storage on redundant servers located onsite at our biorepository and offsite at our secure data center.

Business Continuity Plan

  • Quality Audits — Both internal and external audits are conducted throughout the year at our global biorepository facilities.
  • Facility Back-up Power — Within seconds of an outage, power is transferred, maintaining sample integrity through continued temperature control.
  • Equipment redundancy — Back-up freezers are load-tested weekly for 30 minutes in order to ensure our facilities maintain continuous temperature control and your samples in storage maintain the highest level of integrity. Within seconds of an outage, power in transferred to a backup generator.
  • 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 compliancecap accredited

  • ISO 9001:2008 Registered – We are certified by NSF for our facilities in the US and Europe.
  • College of American Pathologists (CAP) Biorepository Accreditation — We received accreditation from the College of American Pathologists (CAP) Biorepository Accreditation Program in January 2013.cap accredited
  • GTP (Good Tissue Practices) — We’ve been registered by the FDA with a GTP license for the storage and distribution of human cells, tissues and cellular and tissue-based products (License #3004757032).
  • US FDA Title 21 CFR Part 11 Compliant — Both ELPRO® and our BioInventory are validated and US FDA regulatory compliant.
  • Qualtrax® Compliance Software — Our SOPs are maintained with Qulatrax, a quality assurance document management system.
  • 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
  • Certified Cargo Screening Facility — We are a US certified cargo screening facility as part of the Transportation and Safety Administration’s security program.
  • Certified as a Bekannter Versender — (known consignor) in Germany by the LBA (DE/KC/00901-01/0218)

BioProcessing Solutions Alliance Partner RUCDR Infinite Biologics Certifications

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