Analytik Jena, a Germany based manufacturer of laboratory equipment, released a new pharma module of their multiWin pro software, operating their TOC/TNb analyzers. This optional software module enables full FDA 21 CFR Part 11 compliance and data integrity in the highly regulated pharma industry.
To provide its customers in the pharmaceutical industry with worry-free operation and data integrity in compliance with international pharmaceutical regulations and standards, Analytik Jena has released a new FDA 21 CFR Part 11 software module for their new TOC/TNb analyzers.
It is compatible with all multi N/C x300 analyzers operating under multiWin pro and available as an additional option. Thanks to the new functions, customers benefit from significant time savings and ease of use when carrying out audit-proof analyses in strictly regulated industries. New features include, amongst others, a user management system for editing rights and assigning roles to team members, server-based central data management to store data from multiple instruments and access them from any computer, detailed audit trail and versioning with comment functions, and electronic signatures following the dual control principle.
Using the new software module, manual calculation and documentation steps, such as for System Suitability Tests (SST), are eliminated, reducing effort to a minimum. It also provides a clear overview of user roles and method or result versions. As a result, customers can work more conveniently and efficiently, and reduce the risk of errors associated with manual documentation.
The new module ensures conformity with international guidelines, such as FDA 21 CFR part 11, and provides built-in TOC SST functions compliant to USP <643> for bulk water and sterile water, EP 2.2.44, JP 2.59, and the KP.
Software validation services for this module are available as part of Analytik Jena’s equipment qualification service package. It shortens the time until the operational release of the device and significantly reduces customers efforts.
Find detailed information on the new software module here: www.analytik-jena.com/tocnology.
Visit us on booth E16.