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GMP Webinar Data Integrity in Qualification and Validation Documentation Date: Thursday, 21 January 2021, 14.00 15.30 h (CET) Speaker: Dr Rainer Gnibl, GMP Inspector, Local Government of Upper BavariaECA
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Data integrity in qualification refers to the accuracy, consistency, and reliability of data collected during the qualification process.
Various stakeholders involved in the qualification process such as regulatory authorities, manufacturers, and quality control personnel are required to file data integrity reports.
Data integrity in qualification can be filled out by documenting accurate and consistent data, maintaining proper records, and following regulatory guidelines.
The purpose of data integrity in qualification is to ensure that the data collected during the qualification process is reliable, accurate, and consistent to support the safety and efficacy of the product.
Information such as data collection methods, results, analysis, and conclusions must be reported on data integrity in qualification.
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