Vuba aha, TÜV SÜD China Group (izwi ku izina rya "TÜV SÜD") yemeje inyandiko z'ikoranabuhanga n'umukono wa elegitoroniki wa sisitemu yo gucunga azote y'amazi ya Haier Biomedical hakurikijwe ibisabwa na FDA 21 CFR Igice cya 11. Ibisubizo cumi na bitandatu by'ibicuruzwa, byakozwe ku giti cyabyo na Haier Biomedical, byahawe raporo y'amategeko ya TÜV SÜD, harimo n'uruhererekane rwa Smartand Biobank.
Kubona icyemezo cya FDA 21 CFR Igice cya 11 bivuze ko inyandiko z'ikoranabuhanga n'umukono bya sisitemu yo gucunga LN₂ ya Haier Biomedical byujuje ibisabwa mu kubahiriza ubunyangamugayo, ubunyangamugayo, ibanga no gukurikirana amakuru, bityo bikagaragaza ubuziranenge n'umutekano w'amakuru. Ibi bizihutisha ishyirwaho ry'ibisubizo bya sisitemu yo kubika azote mu mazi ku masoko nka Amerika n'Uburayi, bishyigikira kwaguka kwa Haier Biomedical ku rwego mpuzamahanga.
Nyuma yo kubona icyemezo cya FDA, sisitemu yo gucunga azote y'amazi ya HB yatangiye urugendo rushya rwo gushyira mu bikorwa gahunda mpuzamahanga
TÜV SÜD, umuyobozi ku isi mu gupima no kwemeza ibikorwa by’abandi, yibanda ku gutanga ubufasha bw’umwuga mu nganda zitandukanye, ifasha ibigo gukomeza gukurikiza amabwiriza ahora ahinduka. Igice cya 11 gisanzwe cya FDA 21 CFR cyatanzwe n’Ikigo gishinzwe ibiribwa n’imiti muri Amerika (FDA), gitanga ububasha bumwe mu kwandika inyandiko n’umukono, kikerekana ko amakuru y’ikoranabuhanga ari ay’ukuri kandi yizewe. Aya mahame akoreshwa ku bigo bikoresha inyandiko n’umukono mu buvuzi, ibikoresho by’ubuvuzi, n’inganda z’ibiribwa.
Kuva yatangazwa, iri hame ryagiye ryemezwa ku isi hose, atari gusa n'ibigo by'imiti byo muri Amerika, ibitaro, ibigo by'ubushakashatsi, na laboratwari, ahubwo no mu Burayi na Aziya. Ku bigo byishingikiriza ku nyandiko z'ikoranabuhanga n'umukono, kubahiriza ibisabwa na FDA 21 CFR Igice cya 11 ni ingenzi kugira ngo habeho kwaguka ku rwego mpuzamahanga, hagakurikizwa amabwiriza ya FDA n'amahame agenga ubuzima n'umutekano.
Sisitemu yo gucunga azote y’amazi ya Haier Biomedical yitwa CryoBio mu by’ukuri ni "ubwonko bw’ubwenge" ku bikoresho bya azote y’amazi. Ihindura umutungo w’ingero mo umutungo w’amakuru, aho amakuru menshi akurikiranwa, agafatwa amajwi, kandi akabikwa mu gihe nyacyo, ikamenyesha ibintu bitari byo. Ifite kandi uburyo bwo gupima ubushyuhe n’ingano y’amazi byigenga, ndetse n’imicungire y’imikorere y’abakozi. Byongeye kandi, inatanga uburyo bwo gucunga ingero mu buryo bwihuse kugira ngo abantu babone vuba. Abakoresha bashobora guhinduranya hagati y’uburyo bwo gukoresha intoki, gazi, n’amazi bakoresheje gukanda rimwe gusa, binongera imikorere. Byongeye kandi, iyi sisitemu ihuzwa na urubuga rw’amakuru rw’ingero za IoT na BIMS, bigatuma habaho guhuza neza hagati y’abakozi, ibikoresho, n’ingero. Ibi bitanga uburambe bwa siyansi, busanzwe, bwizewe, kandi bunoze mu kubika ubushyuhe buri hasi cyane.
Haier Biomedical yateguye uburyo bwo kubika azote y'amazi bugezweho bukwiriye ahantu hose n'ibice by'amazi, yibanda ku bisabwa bitandukanye byo gucunga ububiko bw'ibipimo bya cryogenic. Ubu buryo bukubiyemo ibintu bitandukanye, birimo ubuvuzi, laboratwari, ububiko bw'ubushyuhe buke, ububiko bw'ibinyabuzima, n'uburyo bwo gutwara ibintu mu buryo bw'ibinyabuzima, kandi buha abakoresha ubunararibonye bwuzuye burimo gushushanya ikoranabuhanga, kubika ingero, gukusanya ingero, gutwara ingero, no gucunga ingero.
Mu kubahiriza amahame ya FDA 21 CFR Igice cya 11, sisitemu yo gucunga azote y’amazi ya Haier Biomedical ya CryoBio yemejwe ko ifite ububasha ku bushobozi bwacu bwo gukoresha ikoranabuhanga n’ubuziranenge bw’inyandiko zacu z’ikoranabuhanga. Iki cyemezo cyo kubahiriza amategeko cyarushijeho kunoza ubushobozi bwa Haier Biomedical mu bijyanye no kubika azote y’amazi, binatuma iki kigo cyihuta mu kwagura isoko ku isi.
Kwihutisha impinduka mpuzamahanga kugira ngo bikurure abakoresha, no kunoza ubushobozi bwo guhangana ku masoko mpuzamahanga
Haier Biomedical yahoraga ikurikiza ingamba mpuzamahanga, ikomeza guteza imbere sisitemu ya "network + localization". Muri icyo gihe, dukomeje gushimangira iterambere rya sisitemu z'isoko kugira ngo zihuzwe n'abakoresha, twongera ibisubizo byacu mu mikoranire, mu guhindura no gutanga serivisi.
Mu kwibanda ku guhanga ubunararibonye bwiza bw'abakoresha, Haier Biomedical yongerera imbaraga imiterere y'aho ikorera binyuze mu gushyiraho amatsinda na sisitemu zo mu gace kugira ngo zisubize vuba ibyo abakoresha bakeneye. Mu mpera za 2023, Haier Biomedical yari ifite umuyoboro wo gukwirakwiza mu mahanga w'abafatanyabikorwa barenga 800, yakoranye n'abatanga serivisi nyuma yo kugurisha barenga 500. Hagati aho, twashyizeho sisitemu y'ubunararibonye n'ikigo cy'amahugurwa, gishingiye ku bihugu by'Abarabu, Nijeriya n'Ubwongereza, hamwe na sisitemu y'ububiko n'ikigo cy'ibikoresho biri mu Buholandi na Leta Zunze Ubumwe za Amerika. Twarushijeho gushimangira imiterere y'aho ikorera mu Bwongereza kandi buhoro buhoro twakomeje kwigana ubu buryo ku isi yose, dukomeza gushimangira sisitemu yacu y'isoko ryo mu mahanga.
Haier Biomedical kandi irimo kwihutisha kwaguka kw'ibicuruzwa bishya, harimo ibikoresho bya laboratwari, ibikoresho bikoreshwa, na farumasi zigezweho, yongera ubushobozi bwo guhangana mu bisubizo byacu. Ku bakoresha siyansi y'ubuzima, ibikoresho byacu byo gupima amashanyarazi byateye imbere mu Burayi no muri Amerika, ibikoresho byacu byo kumisha ibyuma bikonjesha byabonye amabwiriza ya mbere muri Aziya, kandi ibikoresho byacu byo kubungabunga ubuzima byinjiriye ku isoko ry'Uburayi bw'Iburasirazuba. Hagati aho, ibikoresho byacu bya laboratwari byagezweho kandi byiganwa muri Aziya, Amerika ya Ruguru, n'Uburayi. Ku bigo by'ubuvuzi, usibye ibisubizo by'inkingo zikomoka ku mirasire y'izuba, firigo zikoresha imiti, ibikoresho byo kubika amaraso, n'ibikoresho bikoreshwa nabyo biri gutera imbere vuba. Binyuze mu mikoranire ihoraho n'imiryango mpuzamahanga, Haier Biomedical itanga serivisi zirimo kubaka laboratwari, gupima ibidukikije no kuvura indwara, bigatuma habaho amahirwe mashya yo gukura.
Mu mpera za 2023, moderi zisaga 400 za Haier Biomedical zamaze kwemezwa mu mahanga, kandi zagejejwe ku mishinga myinshi ikomeye muri Zimbabwe, Repubulika Iharanira Demokarasi ya Kongo, Etiyopiya na Liberiya, ndetse n'umushinga w'Ubushinwa n'Umuryango w'Ubumwe bw'Afurika wita ku ndwara (CDC), bigaragaza iterambere ry'imikorere y'itangwa ry'indwara. Ibikoresho byacu n'ibisubizo byacu byakiriwe cyane mu bihugu birenga 150 n'uturere. Muri icyo gihe, twakomeje ubufatanye bw'igihe kirekire n'imiryango mpuzamahanga irenga 60, harimo n'Umuryango Mpuzamahanga wita ku Buzima (OMS) na UNICEF.
Kubona icyemezo cya FDA 21 CFR Igice cya 11 ni intambwe ikomeye kuri Haier Biomedical mu gihe twibanda ku guhanga udushya mu rugendo rwacu rwo kwaguka ku isi. Bigaragaza kandi ubushake bwacu bwo guhaza ibyifuzo by'abakoresha binyuze mu guhanga udushya. Mu gihe tureba imbere, Haier Biomedical izakomeza uburyo bwacu bwo guhanga udushya bushingiye ku mukoresha, duteza imbere uburyo bwacu bwo gukwirakwiza ingamba ku isi hose mu turere, mu nzira zitandukanye, no mu byiciro by'ibicuruzwa. Mu gushimangira udushya two mu gace dutuyemo, tugamije gushakisha amasoko mpuzamahanga dukoresheje ikoranabuhanga.
Igihe cyo kohereza: 15 Nyakanga-2024
