Purpose-built biorepositories, stringent processes, and expert staff ensure sample integrity and compliance.
Brooks maintains a commitment to quality with over 300 Standard Operating Procedures (SOPs).
A full-time quality assurance team oversees procedures and monitors evolving regulations to keep us compliant with new standards. Quarterly independent and internal audits ensure our operating procedures are fail-proof. Clients and prospects are also invited to conduct their own audits of our facilities.
- Security – Brooks biorepository facilities are custom-designed and purpose-built for storing samples. Our facilities are auto-secured by card-controlled access areas that admit only trained and certified staff.
- Surveillance – 24/7 video monitoring system and surveillance procedures protect each of our facilities.
- Heat, Smoke and Motion Detectors – Fast response times to security alerts are sent to smartphones of our facilities managers.
- Protected Data Infrastructure – Sample data is stored in an offsite, Category 5 Data Center prioritized for protection by the US government.
- Data Redundancy – All data is backed up daily. We mirror data storage on redundant servers located onsite at our biorepository and offsite at our secure data center.
- In-Process Testing – Incoming material inspection and release, reliability test, design testing, diagnostic test scripts, and blinded test scripts are all performed to ensure that quality of the units is best-in-class from the inception of the equipment through final release to the customer.
- On-going monitoring – Performance monitors are in place to ensure equipment in use at customer sites is operating correctly. This monitoring allows Brooks Life Sciences to proactively service equipment before critical failures occur and negatively impact our clients.
- Change Control – All changes are documented and reviewed by the quality unit and executed using a risk-based approach. Customers will be notified of the planned changes as needed.
- Facility Backup Power – For Biorepositories, the facility backup generators activate within seconds of an outage. Power is transferred to maintain continuous temperature control and protect samples. All other sites have generators that can be activated as needed.
- Equipment Redundancy – Back-up generators are load-tested regularly for 30 minutes to ensure our facilities maintain continuous temperature control and stored samples maintain the highest integrity.
- Guaranteed 24-Hour Resources – Biorepository resupply for diesel fuel, nitrogen, and dry ice ensures that our business essentials are readily available.
Brooks Life Sciences maintains the following certifications to ensure your biomaterials are handled, stored and shipped in a fully compliant manner.
ISO 9001:2015 Certified – Brooks is certified by DEKRA for our facilities in the United States and Europe. See certificate here.
European Medicines Agency (EMA) – Certification of GMP Compliance of a Manufacturer, Brooks is EMA certified in Indianapolis, IN to store GMP working and master cell banks since 2016.
US FDA Title 21 CFR Part 1270/1271 Good Tissue Practices (GTP) – All US Biorepositories are registered by the US Food and Drug Administration with a GTP license for the storage and distribution of human cells, tissue, and cellular and tissue-based products.
College of American Pathologists (CAP) Biorepository Accreditation – Brooks received accreditation in Indianapolis, IN from the College of American Pathologists (CAP) Biorepository Accreditation Program in January 2013.
US FDA Title 21 CFR Part 11 Compliant – Software ELPRO® and BioInventory are validated and US FDA compliant.
Qualtrax® Compliance Software – Our SOPs are maintained with Qualtrax, a quality assurance document management system.
Licensed Tissue Bank in these states – All US sites hold license in New York, California, Delaware, Illinois, Maryland, and Oregon.
International Air Transport Association (IATA) and U.S. Department of Transportation (US DOT) – Compliant shipper of radioactive goods and infectious substances.
Nuclear Regulatory Commission (NRC) – Certified to store and transport radioactive materials in Indianapolis, IN.
Certified Cargo Screening Facility – Brooks is a US certified cargo-screening facility as part of the US Department of Homeland Security’s Transportation Security Administration.
Certified as a Bekannter Versender – Known consignor in Germany by the LBA.