B&W Tek, a mobile spectroscopy solutions company that delivers lab quality Raman, LIBS, UV-Vis and NIR solutions through user-friendly mobile platforms, is proud to announce updates to the NanoRam® handheld Raman spectrometer with the release of enhanced software versions for the operating and data management software.
The NanoRam is an intuitive, state-of-the-art handheld instrument used for nondestructive identification and verification of materials such as active pharmaceutical ingredients (APIs), excipients and intermediates. These software updates provide improvements on data integrity, security and activity tracking through the Audit Trail to make user experience with the NanoRam safe and secure.
These updates are being released in compliance with the future publication of the Data Integrity and Compliance with CGMP Guidance for Industry, the purpose of which is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211 and 212. The guidance provides the FDA’s current thinking on the creation and handling of data in accordance with CGMP requirements, and the NanoRam software updates ensure these guidelines are followed.
NOS Version 5.15: Enhanced Activity Tracking
With this update of the NanoRam operating software (NOS), users will benefit from enhanced activity tracking. The Audit Trail will now record more activities, including abnormal power downs, edits to screensaver settings and failed attempts to login for e-signature. Additionally, if a user fails three consecutive attempts to login for e-signature, the user will be disabled from using that feature until an administrator resets the user.
NID Version 5.15: Improved Data Integrity and Security
The NanoRam ID (NID) software is used for data management and reporting within a secure database. This update allows users to set the database and the archived data to a secured location of their choice. In addition to this improvement, access to privileged information can now be restricted according to user levels for data management.
To learn more about B&W Tek software, click here.
To learn more about the NanoRam, click here.
About B&W Tek
B&W Tek is the global leader in innovative mobile spectroscopy solutions. We utilize our own key building blocks consisting of spectrometers, light sources, sampling accessories and software capabilities to produce portable and handheld spectroscopy and laser instrumentation. B&W Tek provides Raman, LIBS, UV-Vis and NIR solutions for the pharmaceutical, biomedical, physical, chemical, safety, security and research communities.
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