Additional QSpec Elements

ATM2000
This optional extra item describes all the functions of the Mastersizer 2000 software that are relevant to the pharmaceutical industry and details the series of tests that were carried out on each function. Detailing more than 300 tests, this document gives users the option of repeating as many tests as may be considered necessary to establish that the test schedule is a true record of the system testing carried out on the software. This is regarded by many as one of the most powerful software validation tools available.

RTV2004
This is a 2-day GAMP audit is offered subject to completion of a Non-disclosure Agreement and receipt of a covering purchase order. Details of the conduct of audits are also included in MAL2140.

Malvern Quality Audit Standards.
A quantity of these are delivered with each instrument to facilitate the ongoing Performance verification of the instruments performance and are also an important component of the consumables kits for the the sample dispersion units. Replacement packs can be purchased on-line by following this link: http://www.malvernstore.com/