Analytik Jena launches 21 CFR Part 11 Compliance Module for qPCR devices

Analytik Jena expands its qPCRsoft 6.0 software for the qTOWER® iris with an optional module for 21 CFR Part 11 compliance. With this, the software now meets the requirements of the US FDA guidelines for electronic records and signatures – a crucial step for laboratories in regulated environments such as pharmaceuticals, biotechnology, and GxP areas.

The paid module supports laboratories in regulated sectors in complying with legal requirements. It ensures continuous, documented, and traceable data processing – from template design to result approval – thus providing maximum transparency and traceability throughout the workflow.

With this feature, Analytik Jena fills an important 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 possibility 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: The creation, review, and approval of data are carried out according to the four-eyes principle and are securely documented.
– Audit trail & version control: All user activities are automatically logged with timestamps and details – for maximum transparency and traceability.
– User management: Roles and access rights can be assigned individually and adapted to internal quality processes.
– Central data management: qPCR data can be stored securely and centrally – with easy access from multiple devices.
– Qualification and validation services: Analytik Jena supports with IQ/OQ services for hardware and software directly on-site – for smooth and compliant implementation.

The module is now available and can be added as an extension to the existing qPCRsoft software.