Software Tool for Validation of Analytical HPLC Procedures
Name
Martin Vels
Abstract
There is a steady demand, both from academia and industry, for efficient and reliable procedures to analyze various substances by means of High-Performance Liquid Chro- matography (HPLC) equipment. To make sure these procedures are fit for the purpose they were designed for and also as reliable and widely usable as possible, they have to be validated against relevant validation guidelines. This validation process can be time consuming and tedious work, which contains many steps including reading lengthy and often general guidelines, deciding which parts of the guideline are relevant, measuring certain characteristics, performing certain statistical calculations on the gathered data and finally generating a validation report. As this work is done manually, it wastes a lot of valuable time and money which could be spent on improving the actual analytical procedure.
To alleviate the current situation a working prototype of a software tool was created during this Master’s thesis which allows end-users to reduce time and effort needed for analytical procedure validation. The prototype implements one specific valida- tion guideline (The International Conference of Harmonization Harmonized Tripartite Guideline), and allows users to create validations, enter correct values for the specific characteristics, perform statistical calculations on the entered data and generate report based on the previously entered data and calculations. The tool has been designed with extensibility in mind. Specifically, additional guidelines can be added via configura- tion files while additional input validation and report generation components can be plugged into the tool in order to cope with additional requirements.
Extensibility is to large extent achieved by borrowing ideas from dynamic forms specification models, which allow field visibility and form completion conditions to be defined by at the level of individual fields or groups of fields.
As there is an actual need for the software tool that was created during this thesis, it will be developed further by adding new validation guidelines, implementing additional functionality and improving the overall usability of the software.
Graduation Thesis language
English
Graduation Thesis type
Master - Computer Science
Supervisor(s)
Prof. Maron Dumas, PhD; Koit Herodes, PhD
Defence year
2013