内毒素测量和分析软件

EndoScan-V™ 是一种内毒素测量和分析软件,用于生成和报告定量鲎实验数据。该软件通过认证,符合 FDA 要求,可为产品放行执行必要的计算并创建批次报告。为了增加保护,它会对涉及文件和检测数据的所有操作生成安全数据文件和审计跟踪。该软件具有灵活的配置功能和性能选项,可提高运营效率。该软件完全符合 21 CFR Part 11 电子记录规定,确保用户在现场遵守数据完整性指南。

软件功能

  • 在 Windows 7 和 10 上验证
  • 单击并拖动功能可快速轻松地进行模板设置
  • 审计跟踪的自动存档
  • 条形码和自动导出功能可将数据导出至 Excel 或 LIMS
  • 符合最新的全球数据完整性指导标准并提升合规水平
  • 通过用户管理配置文件提高安全性和数据完整性
  • 用户定义的数据库选择经过验证的检测参数
  • 能够对涉及检测数据的所有操作生成安全数据文件和审计跟踪
  • 兼容 Endosafe® 仪和各种微孔板和读取器(Biotek Elx808、Tecan Sunrise 和 ATi 管读取器)
  • 我们的全功能内毒素软件平台集成到 Charles River Cortex™,可用于数据和仪器管理,调查分析和过程监控
  • 自动计算 PPC 中回收的内毒素量,并将其与孔中已知量的内毒素进行比较,为用户提供一定比例的回收

产品代码

产品 代码
EndoScan-V™ 内毒素测量软件 M1250
EndoScan-V™ 软件验证套件 TS600
电子签名 M1300
Endosafe® 客户门户网站

实验室分析师对鲎试剂进行质控检查轻松访问并下载 Endosafe® 分析证书、材料安全数据表、包装说明书和保修表格。立即登录

Endotoxin Testing Software Features


EndoScan-V™

  • Version 6 Features
    1. Eliminate the risk of data loss of your endotoxin testing data with the Backup and Restore functions of the database.
       
    2. EndoScan-V™  endotoxin testing software allows you to make informed, confident decisions through an integrated, all-encompassing endotoxin test management infrastructure.
       
    3. EndoScan-V™  meets current global data integrity guidance standards through digital signatures, searchable audit trails, and comprehensive user management.
       

    EndoScan-V™ and Cortex™ Features

    1. Maintain a complete state of control through real-time tracking and trending.
       
    2. Continuously monitor endotoxin results and create custom alerts to address issues and simplify lab investigations.
       
    3. Gain complete QA/QC oversight, increase visibility into key performance indicators, and proactively manage the operational integrity of your equipment fleet.
       
    4. EndoScan-V™  securely consolidates and analyzes all LAL testing data in real time for necessary internal QA and FDA trending reports, effortlessly elevating your compliance status.

       

  • Product Codes
    EndoScan-V™ 6.0 M1260
    EndoScan-V™ 6.0 Client Manager M1261
    Software Validation TS600

     

Data Integrity

  • Audit Trails, Backup, and Restore Capabilities
    1. EndoScan-V™  offers a Searchable Audit Trail, which allows the ability to reconstruct critical elements of data generation, gives firms more insight into the investigative process during unexpected events, and ultimately ensures compliance with data integrity standards.
       
    2. Search using open keyword or pre-defined searches for critical actions.
       
    3. Switch on comments for Post Assay changes, Global Settings changes, and Digital Signature changes allows the company to capture the Why to the Who, What, and When of an audit trail. This enables a reconstruction of all events if necessary.
       
    4. In EndoScan-V™  audit trail searches can be printed and manually signed.
       
    5. All data and global settings are stored within a PostGres database where a regularly scheduled backup can be set to ensure retrieval of all data and settings if needed. This ensures easy data recovery in the event of a disaster or other unexpected event occurs, eliminating the risk for unacceptable data loss.
       
    6. Automatically schedule database backups (minimum daily).


    Data Integrity Tutorials

LIMS Compatibility

21 CFR Part 11 Compliance

  • Digital Signature & User Management


    Digital Signature

    • The integrated digital signature option in EndoScan-V™  endotoxin testing software permits document review and sign off.
       
    • Implement, integrate, and comply with data integrity guidelines globally.
       
    • Digitally sign test records for all data with EndoScan-V™ and cartridge data.
       

    Digital Signature Tutorials


    User Management

    User management is about controlling user access to how data is generated and stored. It is critical for conforming to data integrity.
     

    • All of the settings and actions are attributed to a privilege in EndoScan-V™.
       
    • Privilege groups can be established so flexibility within user access to any part of the software can be as restrictive or open as needed.
       
    • For additional security each user requires a username and password.
       
    • EndoScan-V™ endotoxin testing software includes an automatic lock function when no activity occurs for a specified time while the test continues to run in the background.
       
    • Configure users, roles, report styles, and other settings.


    User Management Tutorials
    EndoScan-V™ version 6.0 User Management

Tutorials

EndoScan-V™ Supported Products

Lab where QC on LAL reagents is conductedOur endotoxin testing equipment reduces variability and increases operational efficiencies by achieving quantitative results and incorporating flexible configuration capabilities.
 

View Endosafe® testing equipment

Frequently Asked Questions (FAQs) About Endotoxin Testing Software