The latest revision of these software enables data integrity consistent with the regulatory requirements from the US FDA and EU EMEA guidance
Agilent Technologies recently 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.
Data integrity problems in pharmaceutical quality control laboratories are driving more regulatory action than ever before. Support for regulatory requirements as defined in 21 CFR Part 11 and Annex 11 is a key requirement for pharmaceutical and biopharmaceutical manufacturing customers.
While including workflows for the analysis of intact proteins, protein digests and released glycans, MassHunter Acquisition and Quantitative Analysis 11.0 combined with BioConfirm 11.0 now allows for the setup of user roles and permissions, and includes audit trails, checksums, and secure data storage across all software modules. These advanced security features and built-in technical controls minimise security risks while helping to preserve the integrity of the data.
“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 offers systems, software and service solutions that work together to uniquely support your compliance needs. 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.