VDI/VDE 3516 Blatt 3:2016-07
Withdrawn
Validation in GxP-area - Alternative software development models and development methods
Hardcopy , PDF
German - English
07-01-2016
09-02-2024
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
In the guideline, the following methods were selected and considered from numerous methods of agile software development and project management that are used today: Scrum;Extreme Programming (XP);Iterative Conference Room Pilot (CRP, also known as "rapid prototyping");Model Driven Architecture (MDA).
| DocumentType |
Standard
|
| Pages |
36
|
| PublisherName |
Verlag des Vereins Deutscher Ingenieure
|
| Status |
Withdrawn
|
| Supersedes |
| VDI/VDE 3516 Blatt 4:2016-04 | Validation in GxP area - Automated testing |
| VDI 1000:2017-02 | VDI Standardisation Work - Principles and procedures |
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