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Isiqinisekiso
Isiqinisekiso: Chonga izinto ezibalulekileyo.
Igama elithi isiqinisekiso sele linentsingiselo yalo echaziweyo egameni laso: Ukukhusela nokuqinisekisa umgangatho weenkqubo. Kwimveliso yamayeza kunye nokutya okuthobela i-GMP, isiqinisekiso sesityalo okanye isixhobo sinyanzelekile. Siyakuxhasa ekwenzeni zonke iimvavanyo eziyimfuneko zesixhobo sakho seradobio kunye namaxwebhu.
Ngokufaneleka kwesixhobo, ungqina ukuba isixhobo sakho sifakiwe (IQ) kwaye sisebenza ngokuchanekileyo (OQ) ngokuhambelana nezikhokelo ze-GMP. Uphawu olukhethekileyo sisiQinisekiso sokuSebenza (PQ). Esi siqinisekiso sokusebenza siyinxalenye yokuqinisekiswa kwayo yonke inkqubo yemveliso ngexesha lexesha kunye nemveliso ethile. Iimeko kunye neenkqubo ezithe ngqo kubathengi ziyajongwa kwaye zibhalwe.
Unokufunda ukuba zeziphi iinkonzo ze-radobio ezinikezelayo njengenxalenye ye-IQ/OQ/PQ ngokweenkcukacha kwicandelo lethu lobuchwephesha.
Kutheni isiqinisekiso seyunithi yakho yeradobio ibalulekile?
Umgangatho ongaguqukiyo weemveliso esizenzayo - singasathethi ke ngokuphinda-phinda ukuveliswa kweenkqubo zethu zovavanyo - ubalulekile kwiilabhoratri kunye nezibonelelo zemveliso ezisebenza ngokuxhomekeke kwiimfuno ze-GMP okanye ze-GLP. Isibophelelo esinesiphumo sokubonelela ngobungqina obuxhasayo sidinga inani elikhulu leemvavanyo zeyunithi ekufuneka zenziwe kwaye zirekhodwe ngokuchanekileyo. I-RADOBIO inokukunceda ukunciphisa kakhulu umthwalo wokusebenza ohambelana neeyunithi ezifanelekileyo kunye nokuqinisekisa.
Ithetha ukuthini i-IQ, i-OQ kunye ne-PQ?
IQ – isiqinisekiso soFakelo
I-IQ, emele i-Instalification Qualification, iqinisekisa ukuba iyunithi ifakwe ngokufanelekileyo ngokweemfuno zabathengi kuquka namaxwebhu. Igcisa lijonga ukuba iyunithi ifakwe ngokuchanekileyo na, njengoko kucacisiwe kwifolda yesiqinisekiso. Iifolda zesiqinisekiso zinoku-odolwa ngokweyunithi ethile.
OQ -Isiqinisekiso esisebenzayo
I-OQ, okanye iSiqinisekiso sokuSebenza, ihlola kwaye iqinisekisa ukuba iyunithi isebenza ngokufanelekileyo kwimeko engalayishwanga. Iimvavanyo ezifunekayo ziyafumaneka kwifolda yesiqinisekiso.
PQ – Isiqinisekiso sokusebenza
I-PQ, emele iSiqinisekiso sokuSebenza, ijonga kwaye ibhale umsebenzi weyunithi kwindawo elayishiweyo phantsi kweemfuno ezikhethekileyo zomthengi. Iimvavanyo ezifunekayo zichazwa ngesivumelwano esifanayo ngokwemigaqo yomthengi.
Zeziphi iingenelo oza kuzifumana kwi-calibration?
I-RADOBIO inokukunceda ukunciphisa kakhulu umthwalo wokusebenza ohambelana neeyunithi ezifanelekileyo kunye nokuqinisekisa.
Idatha enokwenziwa kwakhona
Idatha ekwazi ukuveliswa kwakhona kwiyunithi yakho ye-radobio - ehambelana neenkqubo zakho kunye nemigangatho
Ubungcali beRADOBIO
Ukusetyenziswa kobuchule be-RADOBIO ngexesha lokuqinisekiswa kunye nokufaneleka
iingcali eziqeqeshiweyo nezinamava
Ukuphunyezwa kweengcali eziqeqeshiweyo nezinamava
Siyavuya ukukuxhasa ngeziqinisekiso zakho ze-IQ/OQ kunye nokudala izicwangciso zovavanyo zePQ yakho.
Qhagamshelana nje nathi.