Quality Alerts Notifications Evaluation and Response Solution for Sites to Communicate Computer Systems Potential Issues in an Alignment Form and Integrated Process

Abstract

The Quality Alert Process is used to communicate IT or computer system related situations that have the potential to adversely impact regulatory requirements (e.g. product quality, patient safety, record integrity and privacy) as well as potentially impacted sites/areas. In addition, the pharmaceutical industry is a highly and strictly regulated environment. Therefore, the data generated in this process are important in order to demonstrate compliance to the external agencies and patient safety. The Quality department is accountable for this process and, with the technology changes across the world, many business decisions are driven thru this department. A commercial off-the-shelf (COTS) software was identified to standardizing a global practice and replace/eliminate the manual and local process in the sites. This software helps communication to all the sites at the same time, with the same information, increasing and improving the process experience. To develop a global solution, Lean Six Sigma methodology were used to identify and implement the requirements to this process. Key Terms — Compliance, Quality Alerts, Response, Simplify, Standardize, Sustainable.