Impamyabushobozi

Ibisabwa: Kumenya iby'ingenzi.

Ijambo "qualification" rimaze gusobanurwa mu izina ryaryo: Kugenzura no kwemeza ireme ry'imikorere. Mu mikorere y'imiti n'ibiribwa ikurikije GMP, "qualification" y'ibikomoka ku bimera cyangwa ibikoresho ni itegeko. Turagushyigikiye mu gukora ibizamini byose bikenewe by'ibikoresho byawe bya radiyo ndetse n'inyandiko.

Iyo ufite ibyangombwa by'igikoresho, uba werekanye ko igikoresho cyawe cyashyizweho (IQ) kandi ko gikora neza (OQ) hakurikijwe amabwiriza ya GMP. Ikintu cyihariye ni imiterere y'imikorere (PQ). Iyi imiterere y'imikorere ni kimwe mu bigize kwemeza inzira yose yo gukora mu gihe runaka no ku gicuruzwa runaka. Imiterere n'imikorere byihariye by'umukiriya biragenzurwa kandi bikandikwa.

Ushobora gusoma serivisi za radiyo ku giti cyawe nk'igice cya IQ/OQ/PQ mu buryo burambuye mu gice cyacu cy'ikoranabuhanga.

Kuki impamyabushobozi y'ishami ryawe rya radiyo ari ingenzi?

Ubwiza buhoraho bw'ibicuruzwa dukora - tutibagiwe no kongera gukorerwa ibizamini byacu - ni ingenzi kuri laboratwari n'inganda zikora ibikorwa hakurikijwe ibisabwa na GMP cyangwa GLP. Inshingano yo gutanga ibimenyetso bifatika isaba ko hakorwa ibizamini byinshi kandi bigafatwa neza. RADOBIO ishobora kugufasha kugabanya cyane akazi gafitanye isano n'ibikoresho byujuje ibisabwa kandi byemezwa.

IQ, OQ na PQ bivuze iki?

IQ - Impamyabushobozi yo gushyiraho
IQ, bisobanura Installation Qualification, yemeza ko igikoresho cyashyizweho neza hakurikijwe ibisabwa n'abakiriya harimo n'inyandiko. Umutekinisiye agenzura ko igikoresho cyashyizweho neza, nk'uko byavuzwe mu bubiko bw'ibisabwa. Ibitabo by'ibisabwa bishobora gutungwa hakurikijwe igikoresho runaka.

OQ - Impamyabushobozi y'imikorere
OQ, cyangwa Urwego rw'Ibikorwa, rugenzura kandi rukemeza ko igikoresho gikora neza mu gihe kitarashyirwamo ibikoresho. Ibizamini bisabwa biboneka mu bubiko bw'inyandiko z'ibizamini.

PQ - Impamyabushobozi y'umusaruro
PQ, bisobanura Performance Qualification, igenzura kandi ikandika imikorere y’igice mu buryo bwashyizwemo ibikoresho hakurikijwe ibisabwa n’umukiriya. Ibizamini bisabwa bigenwa n’ubwumvikane bw’impande zombi hakurikijwe ibisabwa n’umukiriya.

Ni izihe nyungu uzabona mu gupima?

RADOBIO ishobora kugufasha kugabanya cyane akazi gafitanye isano n'ibice byujuje ibisabwa n'ibyemewe.

Amakuru ashobora kongera gukosorwa
Amakuru ashobora kongera gukosorwa kuri radiyo yawe - ahuye n'imikorere n'amahame yawe

Ubuhanga mu bya RADOBIO
Gukoresha ubuhanga bwa RADOBIO mu gihe cyo kwemeza no gutanga impamyabushobozi

inzobere zibifitiye ubushobozi n'uburambe
Ishyirwa mu bikorwa n'inzobere zibifitiye ubushobozi n'uburambe

 

Twishimiye kugufasha mu gutanga impamyabumenyi zawe bwite z’ubwenge n’ubushobozi bwo gusuzuma no gutegura gahunda z’ibizamini by’ubushobozi bwawe bwo gusuzuma.

Twandikire gusa.