Time Management Improvement for Computerized Systems Validations’ Periodic Review Program

Abstract

In the Information Technology Department of Bristol Myers Squibb Manatí Site, the development of a Periodic Review Program was developed for the execution of the Periodic Review Reports for Computerized Systems. The periodic review program was developed for completing these reports months prior to their due dates; however, the program schedule is not being met. The DMAIC methodology (Define, Measure, Analyze, Improve and Control) was used to improve the program management. Ten completed reports were analyzed based on the complexity of their content and time of completion for each section. It was determined that one section of the report was delaying the entire approval process. The section affecting the process was related to another program in the Information Technology Department. To improve the schedule management of the Periodic Reviews both programs had to be aligned to avoid delays. Key Terms ⎯ Computerized System Validation, Information Technology, Management, Periodic Review, Schedule.