Human Error Software Solution Case Study

This case study outlines the development of the Human Error Solution Software (HESS) by Rishabh for a client in the pharmaceutical industry. The objective was to create a technology-based platform to digitize the investigation management process, addressing challenges such as human error detection, inadequate investigations, and ineffective recommendations. The software aims to enhance human reliability, improve product quality, ensure regulatory compliance, and mitigate risks. Key features include problem and investigation management, workflow and task management, and a dashboard for generating reports. The solution also includes alerts and notifications for efficient issue management. Rishabh implemented a configuration framework that integrates various tools to improve product quality and compliance with standards like 21 CFR 11. The outcomes demonstrated significant improvements in action process speed, reliability, and audit trail accuracy, showcasing the effectiveness of the implemented system.