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VDI/VDE 3516 Blatt 3:2016-07

Validation in GxP-area - Alternative software development models and development methods

German title
Validierung im GxP-Umfeld - Alternative Softwareentwicklungsmodelle und -methoden
Publication date
2016-07
Original language
German, English
Pages
36

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Publication date
2016-07
Original language
German, English
Pages
36

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Short description
In this standard the following methods were selected and considered out of numerous methods of agile software development and project management that are applied today: scrum; extreme programming (XP); iterative conference room pilot (CRP, also referred to as "rapid prototyping"); model driven architecture (MDA). To determine whether the methods chosen are suitable for software development in the healthcare and life science industries, each method is compared with the documentation required according to the GAMP® 5 life cycle documents. By assigning the method-specific documents to these general categories, it is possible to evaluate the applicability of each method in a GxP-regulated environment. The detailed methods description and assignment to these categories can be found in Annex A to Annex D of the standard. From this information, the applicability of the methods for validated systems was extracted and executed.
Content
ICS
25.040.40, 35.080
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