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Agilent Technologies Inc.. (1/25/21). "Press Release: Agilent Announces Enhanced Mass Spectrometry and Automation Software Solutions to Support Regulatory Compliance Guidelines". Santa Clara, CA.

	Organisation	EMA (European Medicines Agency)
	Group	EU (govt)
	Product	MassHunter BioConfirm Software
	Person	Seshadri, Sudharshana (Agilent 202101 VP + General of Mass Spectrometry Division)
	Person 2	Goumillout, Naomi (Agilent 201710)

Agilent Technologies Inc. (NYSE: A) today announced the release of MassHunter Workstation Plus 11.0, MassHunter Networked Workstation 11.0, and MassHunter BioConfirm. The latest revision of these software enables data integrity consistent with the regulatory requirements from the US FDA and EU EMEA guidance, providing user management, checksums, tamper detection, and audit trails for MassHunter Acquisition, Quantitative Analysis, and MassHunter BioConfirm. First shipments are expected in June, with quotes available in May.

Support for regulatory requirements as defined in 21 CFR Part 11 and Annex 11 is a key requirement for pharmaceutical and biopharmaceutical manufacturing customers. The need for data integrity solutions is also becoming increasingly crucial for other industries, such as food safety and environmental testing.

In conjunction, Agilent has released VWorks 14.0 Plus, which introduces compliance-enabling features built for the Agilent Bravo Automated Liquid Handling Platform. VWorks Plus extends enabling compliance to automated sample prep on the Bravo, and will begin shipping to customers in mid-February 2021.

“The introduction of compliance features in MassHunter and BioConfirm for LC/TOF and LC/Q-TOF, ensures that all Agilent’s LCMS platforms meet the regulatory needs of our customers,” said Sudharshana Seshadri, vice president and general manager of Agilent's Mass Spectrometry Division. “This further reinforces Agilent as a leading solutions provider to the pharma/biopharmaceutical industry.”

Agilent has been ranked first in the industry in compliance in numerous consecutive LCGC customer surveys and is committed to providing the most powerful analytical tools for the development of drugs and therapeutics to improve the human condition.

About Agilent Technologies

Agilent Technologies Inc. (NYSE: A) is a global leader in life sciences, diagnostics, and applied chemical markets, delivering insight and innovation toward improving the quality of life. Agilent instruments, software, services, solutions, and people provide trusted answers to customers' most challenging questions. The company generated revenue of $5.34 billion in fiscal 2020 and employs 16,400 people worldwide. Information about Agilent is available at www.agilent.com. To receive the latest Agilent news, subscribe to the Agilent Newsroom. Follow Agilent on LinkedIn, Twitter, and Facebook.

Media Contact

Naomi Goumillout
Agilent Technologies Inc
+1 978 314 1862
naomi.goumillout@agilent.com

Record changed: 2021-10-22