Powerful compliance oriented functionalities

GxpManager platform functionalities


FDA 21 CFR part 11

ico-audit-trailAudit Trail: tracking changes to ensure integrity and coherence of data that is subject to standard rules and regulations.



Icon Electronic signature Electronic signature : Guarantee registration integrity, author identification and forbid any change
to the signed element.


ico-workflowWorkflow : Monitoring levels of approval for data or test implementation made easier.



ico-versionningVersionning : Automated versionning guarantees information stability in a sustainable manner by keeping a history of former versions.



icon Access managementAccess management: You can create a profile for each user or group of users according to their access rights for features, databases, reading, writing, deleting or implementation.


ico-piece-jointeAttachments : It is possible to create links to outside files or incorporate attachments (image, document…) directly as recordings.


ico-champs-calculesCalculation fields : You can build or insert complex calculation formulas (duration, standard deviation, averages, progress, any value from other fields…).



360° view : allowing you to see the chain of links related to a record immediately (links in all directions).


Email notifications : Share information by using your electronic mail (Microsoft Outlook© or other) with email attachments.


ico-statistiqueStatistics : You can create and view numerous types of graphic representations for analysing your data in real time, including calculation formulas


icon-matrice-tracabiliteTraceability matrix : You can define matrix for traceability (simple or in star shape) with an overall vision of data (specifications, tests, regulations… coverage).


icon-publication-rapportAutomatic Publishing of reports : Create, automatically publish and record personalised reports.



icon-import-exportImport and export in one click : Import data (and the links between data). Export your data in MS Excel®, MS Word® or MS Project®.

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