A CUTTING EDGE QUALITY MANAGEMENT SYSTEM TO OPTIMIZE QUALITY AND TO ENSURE COMPLIANCE IN LIFE SCIENCES AUTOMATION

摘要

The 21st century is moving with advanced and aggressive technologies in the world. Even mankind found great technologies to help in life sciences industries. There are some great challenges that arise in the life sciences and medicines industries. The great way to deal with this challenge is to interface the engineering technologies with the life science and medicines. The adaptation of engineering in these fields is mandatory in data handling and regulatory compliance in order to maintain high quality of life sciences products. To reduce the risks in poor quality control and regulatory issues, life science industry's needed to go for the engineering solutions. Software solutions should help to maintain the quality management at high level and handle the regulatory compliance. The proposed system is focusing the problems faced by the life science, health care and medical industry in quality arena and the solutions with the engineering technologies to those problems. The life science industries such as pharmacy, biotech and medical devices manufacturers need to dealt with the regulatory compliance and quality management. In the proposed approach the requirements validation factors such as consistency, completeness, and scalability, stability, and validity factors are checked before workflow design. It helps to solve the systems consistency problems and system design issues in the developed stages of the system. Solving these issues at initial stages helps users to save time and cost and it improves the productivity. The centralized quality management system helps to maintain the quality and regulatory compliance at a single system.