Monday, 14 August 2017

Validation and Assessment of Computerized System Software in a Pharmaceutical Facility


Validation is an established approach within pharmaceuticals and healthcare, and the principles of validation extend to computerized systems. Validation concerns establishing documented evidence designed to produce a high degree of assurance that a process or system (including computer systems) will consistently operate according to pre-requisite specifications and quality attributes. Computerized system validation, as with other types of validation, is confirmed through a review of objective evidence to show the requirements for a specific application have been fulfilled. In other words it is proven that a system is fit for purpose. What differs are the specifics, and this paper draws out the main aspects.

A new paper of interest has been published:

The aim of this paper is to assess the current regulations relating to computer system validation, focusing on software (although reference is also made to hardware). The paper provides some best practice advice for the risk assessment of computerized systems.

The reference is:

Sandle, T. (2017) Validation and Assessment of Computerized System Software in a Pharmaceutical Facility, IVT Special Edition Utility Qualification Volume II, pp13-20

For further details, contact Tim Sandle



Posted by Dr. Tim Sandle