QSpec Overview

What is QSpec?

“QSpec” is Malvern Instruments’ brand name for the range of validation tools that Malvern offers to users in support of the validation of their Mastersizer 2000 particle size analysers.

Introduced in 1996 in response to increasing demands for validation assistance from the pharmaceutical industry, the QSpec package has evolved to meet the changing needs of the pharmaceutical industry and the regulatory authorities.

Now, the QSpec validation toolbox consists of the following elements:

Installation Qualification/Operational Qualification (IQ/OQ )
The basic building block of any validation plan, this process confirms that a system is complete, correctly installed and performs to the manufacturer’s specification .

Annual OQ
Performed on or near the anniversary of the installation of the system, the annual OQ provides documentary proof that the system is still performing according to the original specifications.

21 CFR Part 11 Feature Key and Validation Workbook QSE2012
This not only provides users with the means to achieve technical 21 CFR Part 11 compliance but is now supplied with a validation workbook which almost acts like a “validation pill” , giving users all the tools and information required in a single dose so that they can create and execute their validation plans for the Mastersizer 2000 at the precise moment that they are required.

QSE2012 is designed to provide users in the pharmaceutical industry with a powerful validation toolkit to help them to achieve technical 21 CFR Part 11 compliance of their Mastersizer 2000 systems and to enable them to design and complete their validation plans as quickly and cost-effectively as possible.

It consists of three components:

• A feature key to enable the 21 CFR Part 11-compliant features of the Mastersizer 2000 software.

• A copy of Adobe Acrobat to enable data files to be saved as pdf files and to be digitally signed.

• A Validation Planning and IQ/OQ preview binder part number MAL2140.
  This binder provides a single source of documentary material required by users to validate the software and confirm its technical compliance with the requirements of 21 CFR Part 11.
  It also provides a full suite of the IQ/OQ documentation for the Mastersizer 2000 and its sample dispersion units so that early approval can be given for the installation of the system.
  The tasks associated with the validation of a Mastersizer 2000 system are shown diagrammatically here, together with the elements of MAL2140 that assist each task. The function of each element is also briefly described.