Life cycle Management systems

Life cycle management and change control provide a mechanism for continuous improvement. To support continuous improvement through change control a quality system would need to be based on principles of manufacturing science and risk-management. The proposed ICH QIO guidance is an opportunity to accomplish this task. 

There are often many thousands of project documents for MRP II systems. They should all be subject to document (life-cycle) management including following approval processes, indexing, and archiving. Document management must cover the implementation project, operation, and maintenance of the system. 

In addition to the European GMP Guide, Pharmaceutical Inspections Convention Scheme (PIC/S) has an impact on pharmaceutical companies situated mainly in Europe. The Pharmaceutical Inspections Convention Scheme tries to harmonize inspections across the member countries. Therefore, even if the documents are not legally binding, they will be used by inspectors to measure companies against. This organization published in 2003 a new guidance document for the life-cycle management of computerized systems. 

Once the project is completed, the aspects of Part 11 have to be integrated routinely into the system life cycle management. During the system life cycle Part 11 impacts on several steps ... 

Lifecycle concepts also operate at varying application levels - at a management system level, a program level, or an analytical technique level. Life cycle management (LCM), as the name implies, operates at the highest of these... 

Issues for development of expert systems can be divided into eight general categories, which parallel the phases of life cycle management. 

This paper has reviewed the objectives and success factors for developing expert systems, portraying the rapid prototyping cycles of expert systems against the framework of traditional life cycle management practices. 

US EPA, Office of Solid Waste Emergency Response, "System Life Cycle Management Practice Paper on Expert Systems " Washington, DC, 1989. 

System Life Cycle Management Guidance Practice Paper for Expert Systems. U.S. Environmental Protection Agency, Office of Solid Waste and Emergency Response, Washington, DC, 1988. 

The framework for total life cycle management is based on the ideas of the Viable System Model and the St. Galler concept of integrated management (Herrmann and Bergmann 2009 Herrmann 2010). The product life cycle phases are shown at the center of the framework — from product idea to disposal. Sustainable... 

Herrmann C, Bergmann L (2009) Total life cycle management - a system approach. In Proceedings of the 16th CIRP international conference on life cycle engineering, May 4—6, 2006, Cairo, Egypt... 

Jorgensen, T. (2008). Towards more sustainable management systems through life cycle managment and integration. Journal of cleaner production 16, 1071-1080. 

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