Analytik Jena launches new FDA 21 CFR Part 11 module for its latest TOC/TNb instruments

Analytik Jena, a Germany-based manufacturer of laboratory instrumentation, has released a new pharmaceutical software module for its multiWin pro software, designed for its TOC/TNb analyzers. This optional module ensures full compliance with FDA 21 CFR Part 11 requirements and guarantees data integrity within the highly regulated pharmaceutical industry.

To provide customers in the pharmaceutical sector with reliable operation and secure data integrity in line with international regulations and standards, Analytik Jena has developed this new FDA 21 CFR Part 11 software module for its latest TOC/TNb analyzers.

The module is compatible with all multi N/C x300 analyzers running multiWin pro and is available as an optional add-on. Thanks to its new functionalities, users benefit from significant time savings and enhanced ease of use when performing audit-proof analyses in strictly regulated environments. Key features include a user management system for defining access rights and assigning roles, server-based centralized data management allowing storage and access to data from multiple instruments on any workstation, detailed audit trails and version control with commenting functions, and electronic signatures based on the dual-control principle.

By implementing this new software module, manual calculation and documentation steps, such as those required for System Suitability Tests (SST), are eliminated, reducing workload to a minimum. The module also provides a clear overview of user roles and method or result versions, enabling more efficient workflows while significantly lowering the risk of errors associated with manual documentation.

The new module ensures compliance with international guidelines such as FDA 21 CFR Part 11 and includes built-in TOC SST functions that meet USP <643> requirements for bulk and sterile water, EP 2.2.44, JP 2.59, and KP standards.

Software validation packages for this module are available as part of Analytik Jena’s equipment qualification service offering. This shortens the time to operational release of the instrument and significantly reduces the customer’s validation effort. 

Detailed information about the new software module can be found here.