FDA 21 CFR Part 11 - Electronic Records (GLP, GMP)

All LabImage platform applications can be combined with the highly advanced 21 CFR Part 11 (GLP, GMP) module, ensuring secure logging of all actions. A documented approval process, secure data storage and the prevention of data manipulation are essential for working in a GxP setting - the new LabImage module delivers it all. Authorization, authentification and data access are spelt out in detail. The user account system is based on the user's roles within a GxP setting but can easily be extended depending on individual needs. Specific auditing protocols make sure that all LabImage applications are ready for use in 21 CFR Part 11 conforming environments and the GxP module delivers an audit trial to document the analysis steps.

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