GxpManager’s risk analysis application allows you to manage all your procedures for risk management and automatically publishes the risk management file: identification, evaluation, control, acceptability, report…..we ensure complete control of your risk analysis in full compliance with applicable standards such as Gamp5, FDA, ISO 14971, 13485,…
Traceability Matrices
You can define matrix for traceability (simple or star shaped) with a data overall vision (specifications, tests, regulations… coverage).
Statistics
You can create and view numerous types of graphic reprezentations for analysing your data in real time, including calculation formulas.
Calculated Fields
You can build or insert complex calculation formulas (duration, standard deviation, averages, progress, any value from other fields…).
Automatic Publishing of Reports
Create, automatically publish and record personalized reports.