Biomedical Engineering Reference
In-Depth Information
Figure 21.1
Assess the open source software package
Table 21.1
GAMP® 5 software categories
GAMP® 5 software
category
Description
1
Infrastructure software (operating system, middleware,
database managers, development tools, utilities, etc.)
2
No longer used in GAMP® 5
3
Non-confi gured software (little/no confi gurability)
4
Confi gured software (confi gured by the parameterisation
of the application for use by the regulated company)
5
Custom software (custom developed for the regulated
company)
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