Analytik Jena releases a new FDA 21 CFR Part 11-compliant module for their latest TOC analysis series

Analytik Jena, a Germany-based manufacturer of laboratory equipment, has released a new pharma module for its multiWin pro TOC software. This optional software module enables full compliance with the FDA 21 CFR Part 11 standard and ensures data integrity in the highly regulated pharmaceutical industry for its TOC/TNb analyzers operated with multiWin pro software.

To enable their customers in the pharmaceutical industry to operate without interruptions and maintain data integrity in accordance with international pharmaceutical regulations and standards, Analytik Jena has launched a new FDA 21 CFR Part 11 compliant software module for their new TOC/TNb analyzers of the multi N/C x300 series. Thanks to the new features, customers benefit from significant time savings and user-friendliness when conducting audit-proof analyses in this strictly regulated industry.

The new software offers many convenient features: it eliminates manual calculation and documentation steps, such as during system suitability tests (SST), thereby reducing effort to a minimum. Additionally, it provides a clear overview of user roles and method or result versions. This allows customers to work much more comfortably and efficiently, reducing the risk of errors in manual documentation.

Among the new features are, among others, a user management system for assigning roles and editing rights to team members, a server-based central data management system to store data from multiple devices and access it from any computer, detailed logging and version control with a comment function, as well as electronic signatures based on the four-eyes principle.

The new module guarantees compliance with international guidelines, such as FDA 21 CFR part 11, and offers integrated TOC-SST functions that are compliant with USP for bulk water and sterile water, EP 2.2.44, JP 2.59, and KP.

The software validation of this module is available as part of Analytik Jena's device qualification service package. This shortens the time to device release and significantly reduces the effort for the customer.

Detailed information about the new software module can be found here: http://www.analytik-jena.de/tocnology