A document management system for regulatory compliance (US FDA GMP, ISO 9000) in a small medical device manufacturing environment using Lotus Notes.

摘要

Standardization and regulation of an organization's quality and performance has become an obligation benefiting the consumer, and is necessary for improving that company's efficiency and competitiveness. Most organizations are faced with documentation, and document maintenance issues, with respect to such standards and/or regulation requirements.;What are the problems associated with documentation and document maintenance? Using information technology, how can technical and non-technical personnel work together in collaboration to identify and understand issues, processes and requirements, and automate such requirements without hindering the normal operations of the organization?