Pharma Module for TOC/TNb Analyzers

FDA 21 CFR Part 11 compliance module for the highly regulated pharma industry

  • Pharma Module for TOC/TNb Analyzers
    Pharma Module for TOC/TNb Analyzers

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 of the multi N/C x300 series. Thanks to the new functions, customers benefit from significant time saving and ease of use when carrying-out audit-proof analyses in this strictly regulated industry. The new software offers many comfortable functions: It eliminates manual calculation and documentation steps, like for system suitability tests (SST), thus reducing effort to a minimum. It also provides a clear overview over user roles and method or result versions. With it, customers work much more conveniently and efficiently and reduce the risk of errors associated with manual documentation. 

Ensuring guideline confirmity

New features include, amongst others, a user management system for assigning roles and editing rights 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. 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> standards for bulk water and sterile water, EP 2.2.44, JP 2.59, and the KP. The new software module is available as an additional option and is compatible with all multi N/C x300 analyzers operating under multiWin pro. 

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.