As required by US FDA’s 21 CFR Part 11, International Conference on Harmonization of Technical Requirements (ICH), EudraLex Annex 11, and other regulatory agency guidance documents, computer systems used in the pharmaceutical industry and output from software used in regulatory submissions must be validated to assure proper performance. To this end, companies must invest significant time and resources to manually write and perform the validation steps used in software execution.
Validation Made Fast and Easy
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. Updated validation template documents are aligned with the latest regulatory guidance computer system validation such as ICH E6 Good Clinical Practice (GCP) R2.
Automated validation for PopPK analysis
The NLME Validation Suite automatically runs a series of standard test cases and internally validates the Phoenix NLME software, therefore significantly reducing the time it takes to enable NLME to run PopPK analysis. Key features include:
- Runs standard test cases in the user environment
- Compares the 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