21 CFR Part 11 Modules are extented with new release of LabImage

– Functional enhancements to the 21 CFR Part 11 module improve compliance
– Improved device management with methods
– Improvements to data storage in network environments

More and more, 21 CFR Part 11 compliant software solutions for 1D gels and Western blots are finding their way into routine applications. That was reason enough for Kapelan to launch GLP compliance in 2015 with the first LabImage Part 11 software. With the current release, new functions will find their way into the Part 11 catalog. Thus, the login to the user management has been extended, so that several users can register with a personal access.
Access to the LabImage 1D has been possible since the first version with personal access. For this purpose, settings for e.g. Password length and security and history are set.

Each action is also logged in the Audit Trail of the project. In addition to a search function for actions and an extended login in the audit trail, the management of devices and their calibration has also been improved. These innovations allow the creation of image generation methods and thus form e.g. with an imager or transmitted light scanner, a closed system in which the image never leaves the protected environment.

The exclusion of modifications and a full audit trail are the result that seamlessly documents the complete process of image data generation to evaluation. In combination with the fully automatic data evaluation via macros (methods), systems with an high level of automation are created. A valuable time saving to relieve employees of routine procedures.

The use of LabImage in workgroups and multi-user systems has improved with centralized data management. So it is possible that several users work in parallel on a central database. With the use of schemas in data management, self-contained data stores can be created to logically separate workgroups or topic areas.

In the future, in addition to the support of other commercial database systems, the significant expansion of the access right  system is planned, in order to be able to adapt the very large functional scope of the LabImage even better and more flexibly to the desired rights of users and groups.