21 CFR Part 11 Compatible
The LabChip® GX Touch and Reviewer Software contains built-in technical controls and features specifically designed to be compatible with 21 CFR Part 11 requirements. These features include a shared user account database, access controls, device check, enforced sequencing of run steps, audit trails, record copying, record retention, system documentation, and electronic signature controls.
LabChip® Touch instruments generate data records in electronic form which are archived in a Central Data Repository. The LabChip® GX (GxP) Reviewer application can be run from any computer connected to the instrument network and allows modification and maintenance of the records with the ability to perform electronic signatures on the records generated from instruments in the lab system.
The robust and comprehensive LabChip® GXP Software uses secured, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records (Figure 5). In addition, unique combinations of user ID and password for electronic signature are used. Once locked, a record cannot be further modified without a separate signed unlock action (Figure 6).