Utilising JMP for the Validation of a GxP Regulated Bioassay (2026-EU-PO-2831)

The current software (MiniTab) being used requires operator input to perform statistical tests. It also lacks automation, which increases the potential risk. Certain statistical (proportionality) tests in MiniTab also require a manual reformatting of data spreadsheets to pair relevant data points together for analysis, which can pose a significant risk to data integrity.

The solution: using JMP and its scripting language to automate and, where necessary, create data analysis and outputs to support assay validation.

Once a JMP journal has been created, it prevents any alteration to encrypted scripts since it produces local copies of the scripts and keeps the master copies safe.