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.

The 21 CFR Part 11 modules provides the following features:

User Accounting:

• Manage user accounts using the LabImage User Accounts and Data Management tool (UADM)
• Define roles and assign user rights (Administrator, User, Viewer)
• Define Password rules (length, history, strengths, expiration)
• User actions as login/logout, password changes are recorded

Secure Data Storage:

• Data is stored in a secured Database
• Data is transmitted via secured connection, additional security password is used

Record of Audit Trails:

• User interaction is recorded with time stamp, action and user name
• Audit trails can be displayed, exported and printed