assurance quality and compliance

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1 quality assurance and compliance Evidence-based and validated standard operating procedures and ongoing quality control programs are needed to ensure human biospecimens are handled in ways that maximize their usefulness and availability for molecular research. Molecular Oncology Biobanking for Better Healthcare 2008 Comprehensive sample asset management solutions consulting sample storage sample bioprocessing At our expert staff, state-of-theart biorepository facilities, high-quality processes and advanced technology ensure absolute sample integrity, adherence to GxP guidelines and total compliance with global sample management regulations and Good Storage Practices. Sample integrity through lifecycle management and documentation: To support our mission of ensuring sample integrity, we provide a complete chain of custody and temperature history for each sample utilizing US FDA 21 CFR Part 11 compliant uneditable databases. Quality assurance leadership, expertise and consultation: Our commitment to quality is maintained through our development of more than 150 Standard Operating Procedures (SOPs). An experienced quality assurance team consults with you on quality procedures and monitors evolving industry regulations to meet new industry standards and requirements. Excellent track record of passing regulatory audits: Biopharmaceutical companies and regulatory agencies routinely conduct independent audits of our facilities. Quarterly internal audits are performed by our quality assurance team to ensure our operating procedures meet or exceed applicable regulatory standards. onsite/offsite operations management logistics/relocation technology solutions The benchmark in sample management

2 BioStorage Technologies successfully passed our most recent FDA audit with no 483s issued. With expertise in the lifecycle management of samples, partners with you to understand your goals and to provide consult on the development of a business continuity plan for protecting your valuable sample assets. Business Continuity Plan Temperature Monitoring System Each ELPRO monitor is wired separately from the factory freezer thermocouple and is equipped to run on a backup battery which ensures data continues to be logged in the event of power failure. Disaster Recovery Procedures Disaster recovery procedures are available and continually mock tested at our facilities to ensure the highest level of security for your samples. Quality Audits Both internal and external audits are conducted throughout the year at our global biorepository facilities. Facility Back-up Power Our power backup systems are load-tested weekly for 30 minutes in order to ensure that power is transferred to a backup generator within seconds of a commercial power outage. Our facilities maintain continuous temperature control so that your samples maintain the highest level of integrity while in storage. Equipment Redundancy Plan Back-up freezers are onsite at our global biorepositories, ready at any time and are individually validated and maintained. Optimized Environmental Control System A redundancy plan for backup air conditioning exists within our global biorepository facilities. Green power and recycled external air is leveraged whenever possible to maintain a consistent temperature within our facilities. Guaranteed 24-hour Resources To support backup generators, we store onsite a sufficient quantity of fuel to ensure continuity of service and we maintain a 24-hour diesel refueling contract. Continuous liquid nitrogen and dry ice resupply ensures the integrity of sensitive samples.

3 At, we have state-of-the-art security and data protection systems along with alarm escalation procedures that ensure the safety and integrity of your sample assets. Biorepository Security and Data Protection Security Our biorepository facilities are custom-designed and purpose-built for storing samples. All 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 Each sample storage area is equipped with detectors that alert facilities staff when a response is needed. 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 ISISS, our Intelligent Specimen Inventory Storage System and our ELPRO temperature data 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. Redundant Automated Escalation System Our alarm notification system sends alerts via and text immediately to on-call personnel, and dials out to an ascending tree of personnel until the alarm is addressed. These alerts include temperature deviation and freezer power outage. Each freezer is verified on a scheduled basis to ensure the alarm is functional. Continuous Data Protection and Redundancy Client Access Primary Offsite Backup Secondary Offsite Backup Sample Inventory Management System

4 provides flexible sample storage options and utilizes the most advanced temperature monitoring and alarming systems to protect your valuable samples. Secure and Flexible Sample Storage Storage Temperatures Temperatures include controlled room temperature at 15 C to 27 C, walk-in storage at -20 C and 5 C, freezers at -70 C or -80 C and liquid nitrogen tanks in both vapor and liquid phase at -190 C. Chain-of-Custody The chain-of-custody for each sample is traceable at any time throughout the sample lifecycle. Custom barcoding of samples is also available. Our best-in-class procedures ensure accurate audit trail reporting of each sample from arrival through departure or disposal. Sample Tracking Every individual sample in our biorepository is reviewed, inspected and registered with a unique identifier assigned in ISISS (Intelligent Specimen Inventory Storage System), placed in a specific customized storage unit location and stored in one of our secure onsite temperature-controlled areas. Our commitment is to ensuring the integrity and viability of samples to support future research. Greg Swanberg Chief Executive Officer, Temperature Monitoring 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. Qualified Storage Units Dual Alarm Systems Every storage unit is initially temperature mapped to ensure uniform operation. All units contain dual alarm systems that are tested annually along with an ELPRO temperature calibration. Independent Wiring System All storage environments are independently wired for power, temperature monitoring, and alarming, with wires stored above the units and out of the way of traffic.

5 provides you with a team of global logistics experts to help you navigate transportation regulations and manage logistical challenges faced when transporting temperature-sensitive samples to destinations around the world. Reliable Global Logistics Validated Shipping Material Our shipping cartons maintain temperatures for a minimum of 72 hours and up to 120 hours, depending on carton size. Flexible Packaging Standard or custom-designed sample packaging solutions are available upon request. Shipping Hub Our Indianapolis facility is in close proximity to the world s second largest FedEx distribution center. Expedited Cargo Transport Our North American certified cargo screening facility ensures outbound packages are Transportation Security Administration (TSA) compliant, which enables packages to bypass airport screening to reduce shipping delays. Relocation Services A full suite of logistics and relocation services provides transport flexibility for samples from any location around the world. Relofleet Our custom sample transport vehicle can move samples and freezers within the US and Canada. It is vital for clinical trial materials to be packaged and shipped in compliance with industry and government standards, and closely monitored by properly trained individuals. International Clinical Trials May 2011

6 maintains US FDA 21 CFR Part 11 compliant technology systems and is a federally regulated facility adhering to GxP guidelines of Good Tissue Practices, Good Clinical Practices, Good Manufacturing Practices, and Good Laboratory Practices. Certifications, Licenses & Memberships maintain the following certifications to ensure your biomaterials are handled, stored and shipped with full regulatory compliance: ISO 9001:2008 Registered Our facilities in the US and Europe are certified. College of American Pathologists Biorepository Accreditation Good Tissue Practices (GTP) We have 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 # ). US FDA Title 21 CFR Part 11 Compliant Both our ELPRO and our Intelligent Specimen Inventory Storage System (ISISS ) are validated and US FDA regulatory compliant. Qualtrax Compliance Software Our SOPs are maintained with Qualtrax, a quality assurance document management system, which also meets US FDA 21 CFR Part 11 compliance standards. Licensed Tissue Bank We are licensed as a tissue bank in New York (License #TS088), California (License #CNC80754), Illinois (License #0109), Maryland (License #TB1523), Delaware and Oregon. Headquarters 2910 Fortune Circle West, Suite E Indianapolis, IN Phone: Fax: Europe Operations Im Leuschnerpark 1B Griesheim Germany Phone: Fax: Asia-Pacific Operations 4 Kaki Bukit Ave 1, #07-04, Singapore Phone Suite 2401, Room 2480 China Central Place, Tower 3 77 Jianguo Road, Chaoyang District Beijing , China Phone: +86 (10) International Air Transport Association (IATA) and United States Department of Transportation (US DOT) Our trained personnel follow regulations for the shipment of radioactive goods and infectious substances. Nuclear Regulatory Commission (NRC) We are certified to store and transport radioactive materials (License # ). International Society for Biological and Environmental Repositories (ISBER) We are a member of the ISBER Science Policy Committee and participate in the ISBER DNA Quantification and Purity and RNA Integrity Proficiency Testing Programs. Certified Cargo Screening Facility We are a US certified cargo screening facility as part of the Transportation and Safety Administration s security program. The benchmark in sample management Certified as a Bekannter Versender (known consignor) in Germany by the LBA (DE/KC/ /0218)