Analytik Jena Launches 21 CFR Part 11 Compliance Module for qPCR Instruments
Jena / Germany – Analytik Jena has expanded its qPCRsoft 6.0 software for the qTOWER iris with an optional module for 21 CFR Part 11 compliance. This enhancement ensures the software now meets the requirements of the U.S. FDA regulation for electronic records and signatures — a crucial step for laboratories operating in regulated environments such as pharmaceuticals, biotechnology, and GxP settings.
The paid module supports laboratories operating in regulated environments in meeting compliance requirements. It ensures consistent, documented, and traceable data processing throughout the entire workflow — from template creation to result approval — providing maximum transparency and accountability.
With this feature, Analytik Jena closes a critical gap for its customers. “Our customers are increasingly faced with the challenge of meeting strict regulatory requirements. With the new compliance module, we now offer them the opportunity to make their qPCR workflows fully compliant and efficient at the same time,” says Dr. Ines Leonhardt, Product Manager for qPCR Systems at Analytik Jena.
Key features of the module include:
- Electronic Signatures: Secure documentation of data creation, review, and approval following the dual control principle.
- Audit Trail & Version Control: Automatic logging of all user activities with timestamps and details for maximum transparency and traceability.
- User Management: Assign user roles and access rights tailored to internal quality procedures.
- Centralized Data Handling: Secure storage and centralized access to qPCR data across multiple instruments.
- Qualification & Validation Services: Analytik Jena provides IQ/OQ services for hardware and on-site software validation — simplifying compliant implementation.
The module is available now and can be added to existing qPCRsoft installations from version 6.0.
Learn more about the new 21 CFR Part 11 compliance module here.
About Analytik Jena GmbH+Co. KG
Analytik Jena is a leading supplier of analytical measurement technology, instruments in the field of molecular biology as well as liquid handling and automation technology. Precise results and easy handling are the top priorities in the development of Analytik Jena’s laboratory analysis products. Services and instrument-specific consumables round off the extensive range. Analytik Jena is part of the Endress+Hauser Group, a family-owned company based in Switzerland.
