GxpManager

Standard functions

All GxpManager applications have a common technological base that integrates standard functions. This way, the solutions benefit from a proved reliability and can be customized in short time.

Compliance 21 CFR Part 11

Audit trail
GxpManager integrates an audit trail in compliance to the European and US regulations (21CFR Part11).

Electronic signature
GxpManager enables to define different approval statuses. It is possible to use an electronic signature to sign documents, workflows and approve data in the GxpManager base.

Traceability matrices

GxpManager applications integrate a function that facilitates the production of traceability matrices. This way, it is possible to link data of different origins together in order to produce relevant cross analysis. For example, you can create links between technical and regulatory data. GxpManager traceability matrices can be published automatically. It is possible to customize them as they are entirely modifiable.

Safety - Access right management

For each user or group of users, you can define rights on functions as well as on data in the base for reading, writing, deletion or execution. GxpManager secures access rights by organizing access authorizations according to users' profiles.

Import / Export

GxpManager enables you to directly import data and links between data. You have the possibility to export your project data in MS Excel©, MS Word© or MS Project© at any time. GxpManager integrates an automatic data import and export assistant.

Attached files

The powerful external files management functions enable to combine or integrate in the base itself any file (document, picture, spreadsheet...) that the user needs for his project. It is also possible to attach files either on the level of project steps or directly on the level of a record.

Multi-criteria research

Very powerful filters perform precise searches.

Automatic document publishing

You no longer need to spend time on the layout of your documents, GxpManager does it for you. All GxpManager applications offer standard ready to use documents that are published and edited directly with the data of the GxpManager database. Documents are published in Word or pdf format. You can swiftly create new document templates or adapt those provided by the application to meet your company's needs (headings, footer, style, format, standard content of document …).