As discussed in ISPE GAMP 5 the GAMP Categories for hardware and software have been retained in GAMP 5, all be it in a modified format from GAMP4.
The software categories identified in GAMP 5 do not fit with determining the risk to product quality, efficacy or data integrity and no longer plays an integral part to determining that a computer system is fit for purpose.
The complexity and the
Tuesday, 11 May 2010
GAMP5 Software Categories
Posted on 08:17 by Unknown
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