17.06.2019

How should raw data be handled?

Any form of entry must be considered as raw data inclu­ding printouts from balances or temperature recorders, chromatograms and measurement records. The docu­ments that make up the raw data itself are more impor­tant than their evaluations and summaries. In each case they must be stored as prescribed and be accessible as required.

[GMP Compliance Adviser, Chapter 15.B.4]