Agilent Technologies Inc. has 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.”