VDI/VDE 3516 Blatt 3:2016-07
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Validation in GxP-area - Alternative software development models and development methods
Hardcopy , PDF
02-09-2024
German - English
01-07-2016
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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Withdrawn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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