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Iziqu
Izimfanelo: Thola izinto ezibalulekile.
Igama elithi i-qualification selivele linencazelo yalo echazwe egameni lalo: Ukuqinisekisa nokuqinisekisa ikhwalithi yezinqubo. Ekukhiqizweni kwemithi nokudla okuhambisana ne-GMP, i-finance yezitshalo noma imishini iyimpoqo. Sikusekela ekwenzeni zonke izivivinyo ezidingekayo zemishini yakho ye-radiobio kanye nemibhalo.
Ngesiqinisekiso sedivayisi, ufakazela ukuthi idivayisi yakho ifakiwe (IQ) futhi isebenza kahle (OQ) ngokuhambisana neziqondiso ze-GMP. Isici esikhethekile yi-Performance Qualification (PQ). Lesi siqinisekiso sokusebenza siyingxenye yokuqinisekiswa kwayo yonke inqubo yokukhiqiza esikhathini esithile kanye nomkhiqizo othize. Izimo nezinqubo ezithile zamakhasimende ziyahlolwa futhi zibhalwe phansi.
Ungafunda ukuthi yiziphi izinsizakalo ezinikezwa yi-radiobio njengengxenye ye-IQ/OQ/PQ ngokuningiliziwe esigabeni sethu sobuchwepheshe.
Kungani izimfanelo zeyunithi yakho ye-radiobio zibalulekile?
Ikhwalithi engaguquki yemikhiqizo esiyikhiqizayo - ingasaphathwa eyokuphindaphindwa kwezinqubo zethu zokuhlola - iyisisekelo sama-laboratories kanye nezindawo zokukhiqiza ezisebenza ngaphansi kwezimfuneko ze-GMP noma ze-GLP. Isibopho esiphumelayo sokunikeza ubufakazi obusekelayo sidinga inani elikhulu lokuhlolwa kwamayunithi ukuthi kwenziwe futhi kuqoshwe ngokunembile. I-RADOBIO ingakusiza ukunciphisa kakhulu umthwalo womsebenzi ohambisana namayunithi afanelekayo nokuqinisekisa.
Kusho ukuthini i-IQ, i-OQ kanye ne-PQ?
I-IQ - Iziqu zokufaka
I-IQ, emele i-Installation Qualification, iqinisekisa ukuthi iyunithi ifakwe kahle ngokwezidingo zamakhasimende kufaka phakathi imibhalo. Uchwepheshe uhlola ukuthi iyunithi ifakwe kahle, njengoba kuchaziwe kufolda yeziqu. Amafolda eziqu anga-odwa ngokwesisekelo seyunithi ethile.
I-OQ - Iziqu zokusebenza
I-OQ, noma i-Operational Qualification, ihlola futhi iqinisekise ukuthi iyunithi isebenza kahle esimweni sokulayisha. Ukuhlolwa okudingekayo kuyatholakala kufolda ye-qualification.
I-PQ - Iziqu Zokusebenza
I-PQ, emele i-Performance Qualification, ihlola futhi ibhale phansi umsebenzi weyunithi esimweni esilayishiwe ngaphansi kwezidingo ezithile zamakhasimende. Ukuhlolwa okudingekayo kuchazwa ngokuvumelana ngokuvumelana nezincazelo zamakhasimende.
Yiziphi izinzuzo ozothola ngokulinganisa?
I-RADOBIO ingakusiza kakhulu ekunciphiseni umthwalo womsebenzi ohambisana namayunithi afanelekayo naqinisekisayo.
Idatha engaphindwa
Idatha ephindaphindwayo yeyunithi yakho ye-radiobio - ihambisana nezinqubo zakho kanye namazinga akho
Ubuchwepheshe be-RADOBIO
Ukusetshenziswa kobuchwepheshe be-RADOBIO ngesikhathi sokuqinisekiswa kanye neziqu
ochwepheshe abaqeqeshiwe nabanolwazi
Ukuqaliswa ochwepheshe abaqeqeshiwe nabanolwazi
Siyajabula ukukusekela ngeziqu zakho ze-IQ/OQ kanye nokudala izinhlelo zokuhlola ze-PQ yakho.
Mane nje uxhumane nathi.