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GAMP® 5:
Alternative Software Development Models
and Methods in GxP Environments


Article from Pharmaceutical Engineering 1/2012

Summary:

The article examines whether new software development methods such as Scrum, XP, CRP and MDA meet the regulatory requirements for software programming. Software developers and users are provided with recommendations on how alternative software development techniques can be used in regulated industries. The authors - one of them Rolf Blumenthal, Senior Director of Consulting & Product Management with Werum, - show what documentation the software tools provide and compare their scope with the GAMP 5 specifications.

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Format: pdf
Filesize: 2 MB




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