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Showing 1 to 10 of 24 products

MS2000 v5.00 & LATER TEST SCHEDULE

Product Number : CFR2000

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.

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ZETASIZER NANO v4.00 + TEST SCHEDULE

Product Number : CFR2001

Serial Number of system is required upon ordering. 21 CFR Part 11 Test Schedule. 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: Requires Zetasizer series version 4.00 software or later

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MS3000 21CFR11 Test Schedule (v1.20 +)

Product Number : CFR3000

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.

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21CFR ER/ES FEATURE KEY SWARE ZETA NANO

Product Number : CPS0032

Serial Number of system is required upon ordering. 21 CFR Part 11 Zetasizer Nano Series feature key. Enables the Electronic Records and Signatures (ER/ES) features of the Zetasizer Nano series, APS and uV software to assist with meeting the requirements of FDA 21 CFR Part 11

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Zetasizer Nano series research software

Product Number : CPS0033

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

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10KHz Feature Key for Spraytec System

Product Number : CPS0035

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.

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ER/ES Feature Key for Spraytec

Product Number : CPS0037

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.

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Universal Calibration Data Software

Product Number : CPS0039

Serial number of system is required upon ordering. When ordering additional software modules, the current license key must be provided so it can be modified to include the new module. Universal Calibration Data Software. Calculation module for OmniSEC software v5.x.  Allows you to calculate true molecular values from GPC column calibration through the use of refractive index and Viscotek intrinsic viscosity detectors.  Also calculates intrinsic viscosity.

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TD/Light Scattering Data Software

Product Number : CPS0040

Serial number of system is required upon ordering. When ordering additional software modules, the current license key must be provided so it can be modified to include the new module. TD/Light Scattering Data Software. Calculation module for OmniSEC software v5.x.  Allows you to directly calculate absolute molecular weight, intrinsic viscosity, hydrodynamic radius, Mark-Houwink Parameters and branching using Viscotek light scattering and intrinsic viscosity detectors.

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Copolymer Analysis Data Software

Product Number : CPS0041

Serial number of system is required upon ordering. When ordering additional software modules, the current license key must be provided so it can be modified to include the new module. Copolymer Analysis Data Software. Calculation module for OmniSEC software v5.x.  Allows you to calculate the composition of a copolymer or conjugate (where at least one absorbs UV light) by combining data from refractive index and UV detectors.  For the analysis of copolymer composition, PEGylated proteins, membrane proteins, protein conjugates.

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