Computer systems used in the pharmaceutical industry and output from software used in regulatory submissions must be validated to assure proper performance.
Companies must invest significant time and resources to manually write and perform the validation steps used in software execution, 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.
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.
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
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
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