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 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