By Orlando Lopez

Published in: BioProcess Intrenational

Published on: January 20, 2022

Summary Section of the Article: The data integrity strategy's foundation originates in the GDPs that can be found in the GMPs. The expectations and supporting controls listed in Table 1 are performed throughout the data retention period and are the essential elements of data integrity applicable to paper records. The requirements for record integrity do not differ depending on the data format; paper and electronic-based systems. Both systems are subject to the exact requirements. The e-records data integrity controls listed in this article summarize the same listed control applicable to paper records.

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