质量保证认证

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
    切尔姆斯福德，马萨诸塞州
    Manchester, United Kingdom
  • ISO 13485:2016 Certified
    切尔姆斯福德，马萨诸塞州

Biorepository Services

  • ISO 9001:2015 Certified- (Registrar: DEKRA): Scope of certification per site outlined below.
Site Site Activity
印第安纳州印第安纳波利斯（总部） 提供短期和长期的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
布朗克斯，纽约 样品存储和物流管理
Beijing, China 样品存储和物流管理
Quebec, Canada 样品存储和物流管理
Singapore 样品存储和物流管理
Fresno, California 样品存储，物流管理和实验室服务
  • US FDA Title 21 CFR Part 1270/1271 Good Tissue Practices (GTP)- 所有美国生物剂量均已注册，用于人类细胞，组织以及细胞和组织产物的存储和分布。
  • Qualtrax®合规性软件- 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

  • 欧洲药品局（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已获得美国多个州的许可。可以根据要求提供许可位置。
  • Nuclear Regulatory Commission (NRC)- 经过保存和运输放射性材料的认证。该设施可以存储研究样品生物安全水平（BSL）1 - 3。可用的存储温度包括：-190ºC，-80ºC，-70ºC，-20ºC步入式环境， +5ºC步入式环境，控制环境温度。
  • NABP药物分销商认证– Accredited for 3PL Distribution
  • 3PL州许可设施– Licensed for 3PL activities for several states across the US. License Locations can be provided upon request.

Griesheim, Germany

  • 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- 由德国当局定期检查。
  • 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
  • 该设施不是注册的GMP材料存储站点，而是能够存储研究样本BSL 1-3和GMOS BSL 1-3。Available storage temperatures include: -190ºC, -80ºC, -20ºC, +5ºC, and Controlled Ambient Temperature.

布朗克斯，纽约, USA

  • Licensed Tissue Bank- 在纽约州获得许可的GTP
  • 该设施不是注册的GMP材料存储站点，而是能够存储研究样本BSL 1-3和GMOS BSL 1-3。可用的存储温度包括：-190ºC，-80ºC，-20ºC步入式环境和直立存储， +5ºC和受控环境温度。

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.

新加坡，新加坡，亚太地区

  • 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.

符合与我们服务有关的遵循指南：

21CFR第11部分（电子记录和签名） 21CFR第58部分（GLP）
21 CFR Parts 1270/1271 (GTP) 欧洲an Union GMPs – Eudralex Volume 4
21CFR部分210/211（制造中的CGMP） 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]

Sample Management

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库存管理系统包括电子审核步道，用于样品收据的工作流，登录和检索（用于运输或破坏请求）以及跟踪父样本和等分试样之间的关系。

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.

数据管理服务允许通过Azenta Life Sciences建立的清单或客户提供的数据文件将物质数据与库存数据关联。

系统报告技术允许自定义数据报告以支持改进的数据分析。必威注册网址

Azenta生命科学可以检索、包和史p 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.

在全球范围内，Azenta Life Sciences拥有超过160,000平方英尺的存储区域。在每个设施中，设备的数量适合当前和预测的工作。

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在环境故障的情况下以空的，完全合格的备份存储环境的形式利用冗余。