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New ProtectionPlus module for 21 CFR Part 11 compliance with HORIBA Raman systems
23 October 2015 • Author: HORIBA Scientific
HORIBA Scientific, global leader in Raman spectroscopy systems for over 50 years, announces the release of their new ProtectionPlus module for the acclaimed LabSpec 6 Spectroscopy Suite. The fully integrated module seamlessly adds a layer of security and data integrity controls that enable compliant use of HORIBA Raman microscopes within regulated laboratory environments.
The ProtectionPlus module offers a configurable module for system security administrators to put in place and enforce a wide range of security, user and file policies. In combination with correct computer/ laboratory practices, ProtectionPlus allows operators of HORIBA’s Raman instruments to work in compliance with Part 11 of the FDA’s Code of Federal Regulations, Title 21, with regard to electronic records and electronic signatures.
Key functionality within this optional module includes user account management and access control, a full data audit trail to track all operations applied to data, an external event log of software functions, and the availability of electronic signatures. These are complemented by a new suite of qualification protocols (IQ, OQ) for the LabRAM HR Evolution and XploRA PLUS instruments.
Dr. Adrian Knowles, Product Manager at HORIBA, comments, “The new ProtectionPlus module adds a layer of assurance for users in industrial laboratories where regulatory compliance is a strict requirement. Now the recognized functionality of LabSpec 6 can be offered to more users, who can operate knowing they are in compliance with the often complex requirements of regulatory bodies such as the FDA. Behind the immediate ProtectionPlus functionality lies significant new quality processes from development through to validation and release, increasing LabSpec’s existing unrivalled functionality.”
LabSpec 6 is simple yet powerful software, which allows researchers to handle advanced analytical functionalities, in multi-user environments without needing to learn the intricacies of a new software platform.
LabSpec 6 and the new ProtectionPlus module are currently available. Contact your local HORIBA Scientific office for further information, upgrade details, and demonstrations.
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