FDA 21 CFR part 11
Audit Trail: tracking changes to ensure integrity and coherence of data that is subject to standard rules and regulations.
Electronic signature : Guarantee registration integrity, author identification and forbid any change
to the signed element.
Workflow : Monitoring levels of approval for data or test implementation made easier.
Versionning : Automated versionning guarantees information stability in a sustainable manner by keeping a history of former versions.
Access 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.
Attachments : It is possible to create links to outside files or incorporate attachments (image, document…) directly as recordings.
Calculation 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.
Statistics : You can create and view numerous types of graphic representations for analysing your data in real time, including calculation formulas
Traceability matrix : You can define matrix for traceability (simple or in star shape) with an overall vision of data (specifications, tests, regulations… coverage).
Automatic Publishing of reports : Create, automatically publish and record personalised reports.
Import and export in one click : Import data (and the links between data). Export your data in MS Excel®, MS Word® or MS Project®.