Quality Assurance Certifications
Azenta Life Sciences facilities include manufacturing, storage, shipping and receiving, lab and office space. Azenta Life Sciences has established, documented, implemented and currently maintains a quality management system that meets the current revisions of ISO 9001:2015, ISO 13485:2016, College of American Pathologists (CAP) biorepository accreditation standards, as appropriate: GMP, GDP, GCP, GTP, GLP requirements, and fulfills the needs of customers.
Below is a summary of site-specific accreditations, certifications, and licenses as well as a high-level summary of Azenta Life Sciences security processes.
Consumables and Instruments & Cryo Stores
- ISO 9001:2015 Certified
Manchester, United Kingdom
- ISO 13485:2016 Certified
- ISO 9001:2015 Certified - (Registrar: DEKRA): Scope of certification per site outlined below.
|Indianapolis, Indiana (HQ)||Providing short- and long-term sample storage, 3PL distribution of pharmaceuticals and biologics, transport and cold chain/controlled temperature logistics management of sample shipments and basic lab services.|
|Griesheim, Germany||Sample Storage|
|Bronx, New York||Sample Storage and Logistics Management|
|Beijing, China||Sample Storage and Logistics Management|
|Quebec, Canada||Sample Storage and Logistics Management|
|Singapore||Sample Storage and Logistics Management|
|Fresno, California||Sample Storage, Logistics Management and Lab Services|
- US FDA Title 21 CFR Part 1270/1271 Good Tissue Practices (GTP) - All US Biorepositories are registered for the storage and distribution of human cells, tissues, and cellular and tissue-based products.
- Qualtrax® Compliance Software - SOPs are maintained with Qualtrax, a quality assurance document management system.
- International Air Transport Association (IATA) and U.S. Department of Transportation (US DOT) - Compliant shipper of radioactive goods and infectious substances.
Indianapolis, Indiana, USA
- European Medicines Agency (EMA) – Certification of GMP Compliance of a Manufacturer – Certified for storage of GMP master and working cell banks. Initial certification was received in 2016.
- PMDA Accreditation for Storage – Certification with the Japanese Foreign Manufacturers for storage of regenerative, cellular and gene therapy and biological products
- College of American Pathologists (CAP) Biorepository Accreditation – Received accreditation in January 2013 against the BAP and GEN Checklists.
- Licensed Tissue Bank – GTP licensed for several states across the US. License Locations can be provided upon request.
- Nuclear Regulatory Commission (NRC) – Certified to store and transport radioactive materials. The facility can store research samples Biosafety Level (BSL) 1 – 3. Available storage temperatures include: -190ºC, -80ºC, -70ºC, -20ºC Walk-in Environment, +5ºC Walk-In Environment, Controlled Ambient Temperature.
- NABP Drug Distributor Accreditation – Accredited for 3PL Distribution
- 3PL State Licensed Facility – Licensed for 3PL activities for several states across the US. License Locations can be provided upon request.
- GMP Material Storage – Registered with the German Authorities (German Medicinal Product Act Registration according to AMG §64) and allowed to store and distribute all classes of medical products for human use (APIs, IMPs, Final Drug Product, Intermediate Synthesis Product). The facility cannot receive a GMP certification as it is considered a storage operation only and is not a manufacturing site.
- GDP Compliant – Regularly inspected by German Authorities.
- GMO Storage – Certified for the storage of GMO Materials, Risk Class 1
- Certified as a Bekannter Versender — (known consignor) in Germany by the LBA.
- The facility can store research samples BSL 1 – 3, GMO BSL 1 and Animal products (ie Partially purified antibodies, virus suspension, etc.) Available storage temperatures include: -190ºC, -80ºC, -70ºC, -20ºC Walk-in Environment, +5ºC Walk-In Environment, Controlled Ambient Temperature.
Fresno, California, USA
- Licensed Tissue Bank – GTP licensed in the state of California
- The facility is not a registered GMP Material Storage site but is able to store research samples BSL 1 – 3 and GMOs BSL 1-3. Available storage temperatures include: -190ºC, -80ºC, -20ºC, +5ºC, and Controlled Ambient Temperature.
Bronx, New York, USA
- Licensed Tissue Bank – GTP licensed in the state of New York
- The facility is not a registered GMP Material Storage site but is able to store research samples BSL 1 – 3 and GMOs BSL 1-3. Available storage temperatures include: -190ºC, -80ºC, -20ºC Walk-In Environment and Upright Storage, +5ºC, and Controlled Ambient Temperature.
Montreal, Quebec, Canada
- The facility is not a registered GMP Material Storage site but is able to store research samples BSL 1 – 3. Available storage temperatures include: -80ºC, -20ºC, and Controlled Ambient Temperature.
Singapore, Singapore, APAC
- The facility is not a registered GMP Material Storage site but is able to store research samples BSL 1 – 2. Available storage temperatures include: -190ºC, -80ºC, -70ºC, -20ºC, +5ºC, and Controlled Ambient Temperature.
Beijing, China, APAC
- The facility is not a registered GMP Material Storage site but is able to store research samples BSL 1 – 2. Available storage temperatures include: -80ºC, -70ºC, -20ºC, +5ºC, and Controlled Ambient Temperature.
Compliant to following guidelines as they relate to our services:
|21CFR Part 11 (Electronic Records and Signatures)||21CFR Part 58 (GLP)|
|21 CFR Parts 1270/1271 (GTP)||European Union GMPs – Eudralex Volume 4|
|21CFR Part 210/211 (cGMP in manufacturing)||OECD – GLP|
|Good Clinical Practice – ICH||Applicable Regulations from various states within the USA|
|10 CFR Parts 30, 31, 32, 33, 34 35, 36, 39, 40 and 70 (Nuclear Regulatory Commission)|
Facility Security and Data Privacy
Azenta Life Sciences Services utilizes card readers and locked entries for access-control, providing restricted and controlled access. In combination with 24-hour security patrols, our facilities have motion sensors and a full lock down procedures. All staff employed by Azenta Life Sciences must pass a security vetting procedure before hire. To gain access, all visitors to our facilities are required to show identification and must wear a visitor badge. Guests are always to be escorted by an Azenta Life Sciences member of staff.
Access to software systems is controlled through username and password – secondary factor authentication is utilized for remote access to systems.
All Azenta Life Sciences employees must annually review the International Data Protection Policy SOP provided by the Azenta Life Sciences QA department. [G200-0220, International Data Protection Policy]
Azenta Life Sciences Services utilizes Inventory Management Systems to track our customers material within our facilities and associated sample data beyond storage. Systems are FDA 21 CFR Part 11 compliant and utilize audit trails to ensure data integrity is maintained.
Azenta Life Sciences Inventory Management Systems include electronic audit trails, workflows for sample receipt, accessioning and Retrieval (for shipment or destruction requests) and tracking of relationships between parent samples and aliquots.
Systems are flexible in identification of materials and can accommodate client's preferred bar-code nomenclature or custom labels to improve sample tracking.
Project specific information is maintained by Azenta Life Sciences (method dependent on site where service is provided) to allow for consistency in storage amongst common protocols or material types as specified by our clients.
Data Management Services allow for association of material data with inventory data via Azenta Life Sciences built manifest or client provided data file.
System reporting technology allows for custom data reporting to support improved data analysis.
Azenta Life Sciences can retrieve, package and ship materials for next day delivery (amounts dependent on site where service is provided and client-service agreements.) Samples are destroyed only upon client's written request. The requestor must be an authorized project contact.
Globally, Azenta Life Sciences has more than 160,000 square foot of storage area. At each facility, equipment is maintained in volumes appropriate to current and forecasted work.
For each type of equipment, appropriate test cases are developed, and a revision-controlled validation protocol is created and executed (SOP 3000-3001, Validation Master Plan). Equipment qualification is performed by appropriately trained personnel. In addition, a member of Quality Assurance acts as the final reviewer of all testing.
Storage Environment Temperatures are recorded and monitored 24-hours a day by validated remote alarm systems. As soon as a predefined temperature range is exceeded for (defined in temperature monitoring procedures) appropriate personnel are informed via email and call. Temperature monitoring procedures include alarm response requirements. Outside of business hours a dedicated, trained On-Call Team is available to immediately respond to any storage environment or maintenance alarms or other emergencies.
- In case of power failure, Diesel-powered generators provide back-up electrical power to the facility and all temperature critical equipment.
- All storage environments and alarm systems are maintained on a prescribed basis per SOP utilizing guidance from the equipment manufacturer.
- Azenta Life Sciences utilizes redundancies in the form of empty, fully qualified back-up storage environments in case of environment failure.