Analsyer meets Part 11
The Malvern Instruments Mastersizer 2000 laser diffraction based particle size analyser is designed to meet the specific needs of the pharmaceutical industry, and the latest Version 5 software enables users to meet FDA requirements for 21CFR Part 11 compliance. While previous versions of Mastersizer 2000 software already offered a high degree of compliance, the new features available in Version 5 strengthen this and allow greater freedom from procedural constraints.
Key features offered by Malvern's compliant software include more rigorous authority checks, and safeguards against unauthorised access, deletions and use of the system. Where a user is authorised to modify a record, a duplicate is generated and it is this that is edited. An audit trail records the name of the editor, the reason for the change and the date and time when the change was effected. The original record is never deleted and the modified record points back to it. The use of electronic signatures is also supported by the use of Adobe Acrobat PDF Writer.
The Mastersizer 2000 is suited to a wide range of pharmaceutical applications. Malvern Instruments supports the user's validation process with IQ/OQ specifications and certificates and a range of QAS to monitor the on-going performance of the instrument and the sample dispersion units. Malvern also offers its QSpec validation contract, a comprehensive validation support package that includes rights to view the product lifecycle, as well as granting subscribers ultimate rights of access to the software source code.