Computer validation upgrade of the WATS application

Abstract

The reason I chose to complete my project on the upgrade of the WATS computer application is that one of my roles within Merck Sharp and Dohme is the WATS administrator role. As a result I am heavily involved in computer validation and the topic is of great interest to me. The purpose of the project was to provide individuals with an awareness of computer validation and ensure that there is an understanding of the various requirements of computer validation in order to meet both the regulatory and divisional guideline requirements. The introduction chapter aims to provide an overview of the WATS application and computer validation. It details the purpose of the upgrade and describes the differences between the application versions. The methodological details chapter provides an overview on the regulations and guideline requirements in order to complete computer validation accurately, effectively and within compliance. It details the WATS upgrade SLC GMP deliverables and provides a brief description of each deliverable. It details the responsibilities of both the site WATS administrator and the divisional team. It provides the details on the steps required to be completed by the site WATS administrator in order for a successful implementation of the upgrade. Each possible release strategy is also detailed in this chapter along with various plans which were required to be executed as part of the rollout of the upgraded application version. These include the SOP update plan, the upgrade version training plan and the PC rollout plan. The results chapter provides details on the results which were observed during the installation and testing of the upgrade version 3.03. This chapter includes the exceptions noted during testing; any incidents raised post release of the upgrade version and also details of the bug listing on WATS version 3.03. The discussion and lessons learnt chapter describes a brief discussion on the findings and on the lessons learnt as a result of the installation of the upgraded version of the WATS application. The conclusion chapter contains a brief conclusion on the findings of the upgrade, highlights the benefits of being involved in such a project and finally provides a brief summary on the future of the WATS application. Finally a glossary of terms and acronyms used throughout the project were supplied in order for all terminology to be understood by the viewers of the project. This project was compiled and completed on the 26th-Jan-2009 and I certify that at the time of printing all the information acquired was as accurate and up to date as possible.