Implementation of Software Tools for Paperless Processes Oriented in Lean Manufacturing Applied Specifically in the Biotechnology Industry

Abstract

Now days, one major cost area in companies getting scrutinized is paper-based business systems. Traditional paper-based methods for creating and delivering documents are expensive. Some of these large costs include: paper and paper-related expenses, storage, labor, capital expenses, employee productivity, and business processes. The manufacturing technical reports are an essential part for lots release. The lean industries are continuously improving processes to obtain better results throughout the different stages of the process. For this reason the FDA regulated industry is working in a Paperless/Electronic Environment. The research will be about all the requirements needed for the implementation of this electronic tool including the expectations and improvements resulting of this implementation, the qualification requirements, documentation required since the proposed improvements will reflect information that needs to follow the GMP and GDP regulatory requirements. In addition expected results will be based on the proposed changes improvements and implementation. Key Terms ⎯ GDP (Good Documentation Practices), GMP (Good Manufacturing Practices), FDA (Regulated Environment), Lean Manufacturing.