质量Management

Superior outcomes are supported by a culture of accountability and inquiry.

We are committed to ensuring the safety and reliability of the products and services we bring to market through quality strategies, quality systems, and continuous improvement in all aspects of our business.

Azenta Life Sciences不仅将质量定义为我们产品的功能，而且还考虑了我们通过流程和服务所提供的价值，考虑到客户的当前和新兴需求以及市场和行业的变化。结果，我们相信我们可以通过客户的持续成功来最好地衡量我们的成功。

We succeed in continually improving our performance and quality by empowering each employee to act with:

  • Personal accountability and a strong commitment to customer satisfaction
  • A focus on data-driven decision making and rapid problem resolution
  • 与Azenta Life Sciences员工以及外部与我们的供应商和客户内部合作和团队合作

Azenta Life Sciences质量管理系统基于ISO：9001国际标准以及许多其他认证。请访问我们的Certifications pagefor more details.

生物座席服务

Our biorepository services can only be the best in the industry if our people are trained, certified, and fully understand what quality means.

The security and integrity of your research samples are the standard we use to judge ourselves. To ensure we’re doing all we can, we conduct quarterly internal audits of each of our global biorepositories. We also enlist independent auditors to evaluate our practices to ensure operating procedures are practically fail-proof – though we never take that fact for granted.

Whether we’re using a mobile biorepository to transport a lab or storing your samples until they’re needed, your success and satisfaction is our central goal.

存储和管理样品以满足明天的标准

  • Purpose-built biorepositories, stringent processes, and expert staff ensure sample integrity and compliance.
  • Azenta maintains a commitment to quality with over 300 Standard Operating Procedures (SOPs).
  • 全职质量保证团队监督程序并监视不断发展的法规，以使我们遵守新标准。正式安排的独立内部审计确保我们的操作程序是防备故障的。还邀请客户和潜在客户对我们的设施进行自己的审核。

生物设施安全和数据保护

  • Security- Azenta Biorepository设施是定制设计的，并且用于存储样品的专门构建。我们的设施是由接受培训员工的卡控制访问区自动保护的。
  • Surveillance- 24/7视频监控系统和监视程序保护我们的每个设施。
  • Heat, Smoke and Motion Detectors- 对安全警报的快速响应时间发送到我们设施经理的智能手机。
  • Protected Data Infrastructure– Sample data is stored in an offsite, Category 5 Data Center prioritized for protection by the US government.
  • 数据冗余– 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.
  • 在process Testing- 传入的材料检查和释放，可靠性测试，设计测试，诊断测试脚本和盲型测试脚本都进行了，以确保单元的质量从最终发布到客户的最终版本，从设备开始。
  • On-going monitoring– Performance monitors are in place to ensure equipment in use at customer sites is operating correctly. This monitoring allows Azenta 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.

Business Continuity Plan

  • Facility Backup Power- 对于BiorePrositories，设施备份发电机在中断的几秒钟内激活。传递功率以维持连续的温度控制并保护样品。所有其他站点都有可以根据需要激活的发电机。
  • 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.
  • 保证24小时的资源– Biorepository resupply for diesel fuel, liquid nitrogen, and dry ice ensures that our business essentials are readily available.