Software

Serial Number of system is required upon ordering. 21CFR Part 11 Test Schedule for Mastersizer 2000 Version 5.00 software and later. This lists the 21 CFR Part 11-specific tests which have been carried out by Malvern instruments. The tests are laid out so that users can either repeat them and record the results or file them as evidence that such testing has been carried out. Note: This item will not be required by any customers who have ordered QSE2012. Note: If CFR2000 is ordered for an existing installation, the order must include the serial number of the instrument for which it is required.

21CFR Part 11 Test Schedule for Nano V8+

Serial Number of system is required upon ordering. 21CFR Part 11 Test Schedule for Mastersizer 3000 Version 1.00 software and later. This lists 21 CFR Part 11-specific tests which users can reference and, if required, repeat as evidence that they have validated the operation of the Mastersizer 3000's 21CFR Part 11 features.

21CFR Licence Key for OMNIsec v10+

Serial Number of system is required upon ordering. 21CFR pt.11 Zetasizer Nano Series Key

OMNISEC v11.20+ Column Calibration Key

OMNISEC v11.30+ Compositional Key

Serial Number of system is required upon ordering. Zetasizer Nano series research software. Optional software addition providing access to further features and analysis algorithms for the light scattering specialist

Feature key to enable firmware and software upgrades required to acquire data at an acquisition rate of 10kHz (one measurement every 0.1 milliseconds). A software CD-ROM is provided containing the feature key software required to enable this upgrade. Requires Spraytec v1.00 software or higher to be installed. Note: The order must include the serial number of the instrument for which the key is required.

Feature Key to enable the Electronic Records and Signatures (ER/ES) features within Spraytec software, as required by FDA 21 CFR Rule 11. This is a sixteen digit code uniquely encrypted for each Spraytec system which enables the ER/ES features. Once the feature key has been installed, the ER/ES features will always be available on version v2.00 software and later versions as they are installed. Includes a stand-alone copy of the full Adobe Acrobat ® application (not just the Reader) to enable records to be electronically signed. Requires Spraytec v2.00 software or higher to be installed. Note: The order must include the serial number of the instrument for which the key is required.