20.11.2023

How should one handle qualification data?

Many requirements must be observed when handling qualification data. For example, the integrity of raw data must be ensured from its acquisition through processing to archiving. The ALCOA+ principles must be used as a basis. All data transfers must be subjected to critical evaluation. The modalities of data backup and archiving should be defined at an early stage.

[GMP Compliance Adviser, Chapter 6.A]


 

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