Agilent Announces Enhanced Mass Spectrometry and Automation Software Solutions to Support Regulatory Compliance Guidelines
Agilent Technologies (NYSE: A) launched MassHunter Workstation Plus 11.0 and MassHunter BioConfirm, enhancing data integrity compliance with US FDA and EU EMEA standards. Key features include user management, tamper detection, and audit trails, with shipments starting in June 2021. Additionally, VWorks 14.0 Plus is introduced for the Bravo Automated Liquid Handling Platform, aiding compliance in automated sample prep. These updates solidify Agilent's position in the pharma and biopharmaceutical sectors, as highlighted by their top ranking in compliance surveys.
- Launch of MassHunter Workstation Plus 11.0 and MassHunter BioConfirm enhances compliance with regulatory requirements.
- First shipments of the new software expected in June 2021.
- Introduction of VWorks 14.0 Plus extends compliance solutions to automated sample preparation.
- Agilent ranked first in compliance in multiple LCGC customer surveys.
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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
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