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VDI/VDE 3516 Blatt 3:2016-07

Current
Current

The latest, up-to-date edition.

Validation in GxP-area - Alternative software development models and development methods
Available format(s)

Hardcopy , PDF

Language(s)

German - English

Published date

07-01-2016

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

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
Current
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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