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Category: Data Integrity

MES – The Data Integrity engine on the shop floor

January 15, 2019 Christian Wölbeling Data Integrity

According to the FDA (“Data Integrity and Compliance with CGMP Guidance for Industry”), data integrity refers to the completeness, consistency, and accuracy of data. In the last years, the FDA has seen an increase in data integrity violations.

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Data integrity

The role of MES for data integrity

August 22, 2017 Christian Wölbeling Data Integrity

To successfully transfer the process development based control strategy to the commercial production through technology transfer and scale-up, pharmaceutical and[…]

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