VDI/VDE 3516 Blatt 3:2016-07
Current
The latest, up-to-date edition.
Validation in GxP-area - Alternative software development models and development methods
Hardcopy , PDF
German - English
01-07-2016
Preliminary note
Introduction
1 Scope
2 Normative references
3 Selected methods and their comparison with
the documentation required by GAMP[R] 5
4 Applicability of methods for validated systems
5 Mapping of the methods to the V-model
lifecycle
6 Evaluation of the methods in relation to
GAMP[R] 5
Annex A - Scrum
Annex B - Extreme programming (XP)
Annex C - Iterative conference room pilot (CRP)
Annex D - Model-driven architecture (MDA)
Bibliography
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