PRACTICAL EXAMPLE OF THE APPROACH TO THE VALIDATION OF AUTOMATED LABORATORY INFORMATION SYSTEMS
Journal Title: Вчені записки Таврійського національного університету імені В. І. Вернадського. Серія: Технічні науки - Year 2018, Vol 29, Issue 2
Abstract
The article analyzes the existing scientific and practical publications on the development and implementation of automated laboratory information systems (LIMS). The physical layout and architecture of the LIMS data flow are considered, and the functional capabilities of the system are analyzed. The phases of validation and the corresponding project activity are determined. The resulted examples of the contents of test protocols of the stage of qualification of the installation and the stage of functioning. The peculiarity of the operation stage protocol is determined. It is concluded that the proposed unified approach can be applied to LIMS validation, which will correspond to the expectations of regulatory bodies.
Authors and Affiliations
С. В. Медушевський
Keywords
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