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Qdossier Qsauri
"L"

legacy computerized systems
Guideline or reference source
PIC/S Good practices for computerised systems in regulated GXP environments
Definition
These are regarded as systems that have been established and in use for some considerable time. For a variety of reasons, they may be generally characterised by lack of adequate GMP compliance related documentation and records pertaining to the development and commissioning stage of the system. Additionally, because of their age there may be no records of a formal approach to validation of the system.
Broader Term
computerized system
 

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