VDI/VDE 3516 Part 5:2019 Edition
$27.95
Validation in the GxP area – Types of raw data
| Published By | Publication Date | Number of Pages |
| DIN | 2019-03 | 23 |
This standard is concerned primarily with raw data covering GxP rules. The archiving of data is only considered marginally in this context. The standard defines the essential terms to establish a basis for common understanding. Subsequently, basic "models and methods" are presented, so that processes can be described, and the corresponding raw data be identified and specified within them. Subsequently, a practical section follows transferring the specified terms, models and methods to the concrete world of GxP-relevant processes.
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