Ensured compliance with Good Practices (FDA, EMA, ICH, etc.)
GxpManager’s Deviation and CAPA application allows you to create and manage your Deviation and CAPA in a simple and efficient way. You plan, launch and follow your action plans. You strengthen the coverage of your deviations and follow the information in real time.
Management of the CAPA process is automated. You improve the monitoring of deviations by accessing the provisional closing dates, actual delays and percentages of progress.
FDA 21 CFR part 11
Workflow
Monitoring levels of approval for data or test implementation made easier.
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.
Automatic Publishing of Reports
Create, automatically publish and record personalized reports.
Digitize Paper Forms
Digitize more than 1000 paper forms without altering the content and signature processes...
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