Data integrity refers to the accuracy, completeness, and consistency of GxP data over its entire lifecycle: Quality Management Case Study, NUI, Ireland
| University | National University of Ireland (NUI) |
| Subject | Quality Management |
Data integrity refers to the accuracy, completeness, and consistency of GxP data over its entire lifecycle. The steps that need to be overseen include the initial generation and recording, the\ processing of the outcome/use, the retention, retrieval, archive, and finally the destruction.
Data integrity means that all the steps defined above are well managed, controlled, and documented, and therefore the records of the activities follow the ALCOA principles described in the guidelines. The ALCOA and ALCOA+ principles have been in place for several years in the industry and are widely
known and implemented. Achieving data integrity compliance, for paper, electronic and hybrid systems, requires translation of these principles into practical controls in order to assure GxPimpacting business decisions can be verified and inspected throughout the data lifecycle.
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