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TOCnology Made for Pharma

Wed 18 Dec, 2024

Analytik Jena launches new FDA 21 CFR Part 11 compliance module for operating their latest series of TOC analyzers

Jena, December 18, 2024 – 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 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. 

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. 

Find detailed information on the new software module here: www.analytik-jena.com/tocnology

About Analytik Jena GmbH+Co. KG 

​Analytik Jena is a leading global supplier of analytical measurement and automation technology in the fields of chemical analysis, molecular biology, and liquid handling. Precise results and ease of use are the top priorities in the development of Analytik Jena's laboratory analysis products. Instrument-specific consumables and outstanding customer services and complete the extensive range. Analytik Jena is part of the Endress+Hauser Group, a family-owned company based in Switzerland. 

Contact Analytik Jena GmbH+Co. KG
Christin Domin | PR & Media
Tel: +49 170 7659446
pr@analytik-jena.com | www.analytik-jena.com

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