Mastersizer and Spraytec

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.

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.

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.

ER/ES feature for MS2000 v6.0 DI Release

Serial Number of system is required upon ordering. Feature key to enable the 21CFR part 11 features within the Mastersizer 3000 software. This is a unique, encrypted code specific to each Mastersizer 3000 system which enables access to the audit and security functions provided in the software to aid technical compliance to the rule. Note: If this is ordered for an existing installation, the order must include the serial number of the instrument for which it is required.

Serial Number of system is required upon ordering. Software upgrade feature key for the Mastersizer 3000E software. This provides users of the Mastersizer 3000E with the ability to use the premium features of the full Mastersizer 3000 software, including: 1) Operation of the Hydro MV and Hydro LV automated liquid dispersion units. 2) Data quality tools. 3) SOP player measurement sequencing tools. 4) Real-time data trending and variability checks. 5) Software licensing for use on multiple workstations. 6) Future premium software updates. Note: If this upgrade is ordered following the initial purchase of the Mastersizer 3000E system then the system serial number must be provided with the order.

Serial Number of system is required upon ordering. Feature key to enable the Electronic Records and Signatures (ER/ES) features of Mastersizer 2000 software (Version 5.1 or later) to meet the requirements of FDA 21 CFR Part 11. This is a 16-digit code uniquely encrypted for the Mastersizer 2000 system for which it is required. Once the feature key has been installed, the ER/ES features on subsequent versions of software will automatically be available to the user 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. Unless this item forms part of the first delivery of the user’s Mastersizer 2000, it will also include the latest version of the Mastersizer 2000 software.Also includes a CD-ROM providing review copies of all Mastersizer 2000 IQ and OQ documents, along with a suite of validation documents.