Agilent Announces New NovoCyte Flow Cytometer System Software for 21 CFR Part 11 Compliance

NovoExpress enables regulatory compliance for pharmaceutical and biopharmaceutical manufacturing

Agilent Technologies announced the release of new NovoExpress software that introduces integrated compliance tools for NovoCyte flow cytometer systems. The compliance-enabling features enable users to meet regulatory requirements defined in FDA 21 CFR Part 11 and Annex 11.

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“Continuing to expand the capabilities of the NovoCyte platform to meet the needs of our customers is a key component of our mission for democratizing flow cytometry assays for scientists in life science research and healthcare”

There is immense pressure on pharmaceutical and biopharmaceutical manufacturers to demonstrate compliance with regulatory requirements such as 21 CFR part 11. NovoExpress software compliance features provide essential tools for ensuring that the data and electronic records generated with NovoCyte flow cytometers are trustworthy, authentic, and reliable, as required by regulatory authorities worldwide, and also meet GxP manufacturing compliance guidelines.

The new NovoExpress software strengthens support for customers conducting flow cytometry as a cellular-analytics tool in therapy development, manufacturing, diagnosis, and prognosis applications. Combining Agilent instrumentation and software, NovoCyte systems deliver a workflow that is automatable and auditable. Enabling data integrity consistent with requirements defined in FDA 21 CFR Part 11 and Annex 11 for electronic records and electronic signatures is an important hurdle to overcome for pharmaceutical and biopharmaceutical manufacturing customers.

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“Continuing to expand the capabilities of the NovoCyte platform to meet the needs of our customers is a key component of our mission for democratizing flow cytometry assays for scientists in life science research and healthcare,” said Xiaobo Wang, general manager of the Real-Time Cell Analysis and Flow Cytometry business unit within the Cell Analysis Division at Agilent. “We are pleased to provide the compliance-supporting functionalities to Agilent NovoCyte users to enhance productivity and efficiency, particularly in the manufacturing environment.”

“Agilent’s goal is to provide trusted quality and compliant solutions to the market. Developing and validating NovoExpress capabilities enabling 21 CFR Part 11 compliance is fully aligned with these goals,” said Todd Christian, vice president and general manager of the Cell Analysis Division at Agilent. “We are excited to have this available for our customers, particularly to support scientists with a streamlined workflow in therapy development, manufacturing, and quality control settings.”

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