FDA 21 CFR Part 11 Regulations - GxP

Even if researchers at pharmaceutical companies use the same scientific methods as their colleagues in other research departments or at a university, they will always face additional challenges. Standards for Good Laboratory Practice (GLP) as well as other practice standards (GxP) have their impact on any software deployed in pharmaceutical development. First of all, it is essential that the software allows for the assignment of various roles to the users, e.g. granting administrator rights or limiting a user's ability to create new projects. At the same time, an extremely high level of detail is key to a complete and consistent documentation.

This LabImage application fulfills all needs within a regulated environment - from authorization and user authentification to secure data storage to documenting all document changes within a specific audit trail. When installing the LabImage platform, researchers in the pharmaceutical industry can simply decide to have the GxP application run with every analysis, thus ensuring GxP-compliant software processes that will stand every GxP test.