ComSoft 21 CFR Part 11 - 醫藥行業專業版軟體

訂貨號  0554 1705

  • 适用于制药工业的直观并且可验证的软件

  • 用图形和表格显示所有测量参数

  • 轻松创建和管理报告

  • 数字签名和审计跟踪确保了最大的安全性

软件 ComSoft 21 CFR Part 11 是一种可验证的、用于编程和读取 Testo 数据记录仪以及用于数据存档的软件。它满足 FDA 21 CFR Part 11 的要求。

産品描述

The ComSoft CFR 21 Part 11 software is validatable software and fulfils all the FDA's requirements in the framework of a closed system. Conformity with the CFR directives is confirmed by an independent institution.

Advantages and functions of the ComSoft 21 CFR Part 11 software

  • Digital signature and audit trail for the traceability of user activities offer maximum security and safety
  • Storage of raw data in tamper-proof file format
  • Detection of transfer errors using checksums
  • Inactivity lockout to prevent unauthorized access
  • Intuitive and clearly-structured user interface. It guides users through individual work steps and enables effortless export of data, creation of reports and carrying out of analyses
  • The software offers the opportunity to display and evaluate all recorded measurement parameters in both graphic and tabular format
  • Measurement menus can be individually tailored and the data loggers can be brought together and organized into groups in clear tree structures according to the application site and intended use. That enables clear display of the whole transportation route
  • Further advantages: Online measurement, creation of formulas, scientific-statistical evaluation (min./max./mean value, limit value violation)

 

産品包含

电脑PC安装 testo ComSoft 21 CFR Part 11 软件(需注册下载),包括说明手册。