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Product Number :
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.
Product Number :
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.