DEVELOPMENT OF METHODOLOGY AND PRINCIPLES FOR THE COMPLEX FORMATION AND QUALITY EVALUATION OF THE VALIDATION DOCUMENTATION PACKAGE OF AN AUTOMATED INFORMATION SYSTEM
Journal Title: Вчені записки Таврійського національного університету імені В. І. Вернадського. Серія: Технічні науки - Year 2018, Vol 29, Issue 1
Abstract
The article raises a problem of constructing effective quality, reliability, security, and integrity of data assurance in pharmaceutical sphere when using the automated information system. There are presented the results of theoretical studies related to the development of a methodology for constructing a quality assurance system of the project for the development, implementation, and validation of the automated information system designed to deal with the rapidly changing user requirements. Taking into account the principles of priority, complexity, and compatibility, there is proposed a generalized scheme for the design and use of documentation. There is introduced the concept of building the basic provisions of the universal automated information system validation documentation package, which allows on the basis of organization and integration principles to numerically assess its regulatory components and build the document structure. There have been developed the scientific approaches to construct the structural elements of the validation documentation package for the automated information system, which include the use of a three-level hierarchical scheme and the procedure for assessing the regulatory components of international standards. This makes it possible to distinguish innovative characteristics (a process approach, a system approach, a degree of demand, a degree of perception), taking into account the specifics of production.
Authors and Affiliations
С. В. Медушевський
Keywords
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