Validation results in minutes

制药行业中使用的计算机系统以及监管提交中使用的软件输出结果必须经过验证,以确保适当的性能。

公司必须按照美国 FDA 21 CFR 第 11 部分、技术要求国际协调会议 (ICH)、EudraLex 附录 11 和其他监管机构指导文件的要求,投入大量时间和资源来手动编写和开展用于软件执行的验证步骤。

The Phoenix NLME™ Validation Suite is integrated with Phoenix® software and provides validation in under 30 minutes with locked PDF reports containing links to results. 更新的验证模板文件与最新的监管指南计算机系统验证(例如 ICH E6 药物临床试验质量管理规范 (GCP) R2)保持一致。

Reduce time to enable NLME to run analysis

The NLME Validation Suite automatically runs a series of standard test cases and internally validates the software, significantly reducing the time it takes to enable NLME to run popPK analysis.

  • Runs standard test cases in the user environment
  • Compares generated numerical results to reference output results
  • Generates non-editable PDF Validation Report with embedded links to csv files of outputs and difference in outputs
  • Comes with Validation Suite template documents in Word for easy modification and use
  • Computation Engines Verification Report shows comparison of results from NLME with other software with similar run method
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Ensure compliance always

Use Phoenix NLME Validation Suite to ensure compliance under the following conditions:

  • Upon a new installation of Phoenix NLME
  • After upgrade to Phoenix NLME from a previous version of Phoenix NLME
  • Upon re-installation of Phoenix NLME
  • If a change to the implemented Phoenix NLME system is determined as part of the internal
    change control process to impact the validation status of the system
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Validation life cycle templates

Validation Life Cycle Templates included in Phoenix NLME Validation Suite:

  • Validation Plan
  • Phoenix NLME Requirements Specification
  • Test Plan
  • Phoenix NLME Traceability Matrix
  • Validation Summary Report
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