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Nidhi Kadam*, Mitali Dalwadi and U. M. Upadhyay


Data integrity is an important current issue for regulators around the world. During inspections a many problems found by the pharmaceutical regulatory agency because poor practices develop the degraded product for patients. Information and result are collected in form of data. This data becomes one of the most valuable information for organization but without integrity, this data is not much useful. Accuracy and original data increase the chances of performance of an organization. Due to data integrity all the data will remain as it is complete throughout the life cycle of data. It requires good documentation practice which leads to conservation of data from being change and copy or move. In data integrity, data means all the original information including the source data and data about data, which may be present in soft copy or hard copy. To satisfy all the parameters of data integrity many important organization like USFDA, health Canada and EMEA endorse the use of ALACO.[8]

Keywords: Data integrity, ALCOA, regulatory body, USFDA, 21-CFR.[8]

[Full Text Article]

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