Munguva pfupi yapfuura, TÜV SÜD China Group (inozonzi "TÜV SÜD") yakasimbisa zvinyorwa zvemagetsi uye masiginecha emagetsi eHaier Biomedical's liquid nitrogen management system zvinoenderana nezvinodiwa neFDA 21 CFR Chikamu 11. Gumi nenhanhatu mhinduro dzechigadzirwa, dzakazvimiririra neHaier Biomedical, vakapihwa iyo TÜV SÜD yekuteerera chirevo, kusanganisira iyo Smartand Biobank nhevedzano.
Kuwana FDA 21 CFR Chikamu 11 certification zvinoreva kuti marekodhi emagetsi uye masiginecha eLN₂ manejimendi system yeHaier Biomedical inosangana nezviyero zvekuvimbika, kutendeseka, kuvanzika uye kuteedzera, nekudaro kuve nechokwadi chemhando yedata uye kuchengetedzeka.Izvi zvichamhanyisa kutorwa kwemvura nitrogen yekuchengetedza system mhinduro mumisika yakaita seUS neEurope, ichitsigira kuwedzera kwenyika dzeHaier Biomedical.
Kuwana chitupa cheFDA, HB's liquid nitrogen management system yatanga rwendo rutsva rwekudyidzana nedzimwe nyika.
TÜV SÜD, mutungamiri wepasi rose mukuyedzwa kwebato rechitatu uye chitupa, anogara akatarisana nekupa rutsigiro rwehunyanzvi mukuteedzera maindasitiri, kubatsira mabhizinesi kuti arambe achienderana nemirau inoshanduka.Iyo yakajairwa FDA 21 CFR Chikamu 11 yakapihwa neUS Chikafu neDrug Administration (FDA), inopa marekodhi emagetsi marekodhi akafanana emutemo marekodhi akanyorwa uye siginicha, kuve nechokwadi uye kuvimbika kwedata remagetsi.Iyi chiyero inoshanda kumasangano anoshandisa marekodhi emagetsi uye masiginecha mubiopharmaceuticals, zvishandiso zvekurapa, uye maindasitiri ezvekudya.
Kubva payakaburitswa, chiyero chakagamuchirwa zvakanyanya pasi rese, kwete chete nemakambani ekuAmerica biopharmaceutical, zvipatara, masangano ekutsvagisa, uye marabhoritari, asiwo neEurope neAsia.Kumakambani anovimba nemarekodhi emagetsi nemasiginicha, kutevedzera zvinodiwa neFDA 21 CFR Chikamu 11 kwakakosha pakuwedzera kwakadzikama kwenyika dzese, kuve nechokwadi chekuteedzera mirau yeFDA uye zvinoenderana nehutano nekuchengetedza zviyero.
Haier Biomedical's CryoBio liquid nitrogen management system ndeye "hungwaru huropi" hwemvura ine nitrogen midziyo.Inoshandura zviwanikwa zvemuenzaniso kuita zviwanikwa zve data, iine data rakawanda richitariswa, kurekodhwa, uye kuchengetwa munguva-chaiyo, kunyevera kune chero zvisizvo.Iyo ine zvakare yakazvimiririra yakazvimirira mbiri kuyerwa kwekushisa uye mazinga emvura, pamwe neherarchical manejimendi ekushanda kwevashandi.Mukuwedzera, inopawo kutarisa kwekuona kwemasamples ekukurumidza kuwana.Vashandisi vanogona kushandura pakati pemanyorero, gasi-chikamu, uye mvura-chikamu modhi nekudzvanya kamwe chete, kuvandudza kugona.Zvakare, iyo sisitimu inobatana neIoT uye BIMS sampuli yeruzivo chikuva, ichigonesa kubatanidza isina musono pakati pevashandi, zvishandiso, uye masampuli.Izvi zvinopa sainzi, yakamisikidzwa, yakachengeteka, uye inoshanda yekupedzisira-yakaderera tembiricha yekuchengetedza ruzivo.
Haier Biomedical yakagadzira yakazara-yekumira mvura nitrogen yekuchengetera mhinduro inokodzera zvese zviratidziro uye vhoriyamu zvikamu, inotarisa pane zvakasiyana zvinodiwa zvemuenzaniso cryogenic kuchengetedza manejimendi.Mhinduro yacho inobata mamiriro akasiyana-siyana, anosanganisira ekurapa, marabhoritari, yakaderera-tembiricha chengetedzo, biological series, uye biological transportation series, uye inopa vashandisi ruzivo rwakakwana rwekuita zvinosanganisira engineering dhizaini, chengetedzo yemuenzaniso, kutora sampuli, kutakura sampuli, uye sampuli maneja.
Nekutevedzera FDA 21 CFR Chikamu 11 zviyero, Haier Biomedical's CryoBio liquid nitrogen manejimendi system yakasimbiswa yechokwadi yemasiginecha edu emagetsi uye kuvimbika kwemarekodhi edu emagetsi.Ichi chitupa chekuteerera chakawedzera kukwikwidza kweHaier Biomedical mumunda wemvura nitrogen kuchengetedza mhinduro, ichimhanyisa kuwedzera kweiyo brand mumisika yepasi rose.
Kurumidza shanduko yepasirese kukwezva vashandisi, uye kugadzirisa kukwikwidza kwemisika yepasirese
Haier Biomedical yagara yakanamatira kune yepasi rose zano, ichienderera mberi ichisimudzira "network + localization" mbiri system.Panguva imwecheteyo, isu tinoenderera mberi nekusimbisa kuvandudzwa kwemusika masisitimu kutarisana nevashandisi, tichivandudza mamiriro edu ekugadzirisa mukudyidzana, kugadzirisa, uye kuendesa.
Tichitarisa pakugadzira yakanakisa mushandisi ruzivo, Haier Biomedical inosimbisa nharaunda nekumisikidza zvikwata zvemuno nemasisitimu ekukurumidza kupindura kune zvinodiwa nemushandisi.Pakupera kwa2023, Haier Biomedical yave neinetiweki yekugovera mhiri kwemakungwa yevanopfuura mazana masere vanobatana, yakabatana nevanopfuura mazana mashanu mushure mekutengesa masevhisi.Zvichakadaro, takagadzira ruzivo uye nzvimbo yekudzidziswa, yakanangana neUnited Arab Emirates, Nigeria neUnited Kingdom, uye nzvimbo yekuchengetera zvinhu uye yekutakura zvinhu iri muNetherlands neUnited States.Isu takadzamisa nzvimbo yedu muUK uye zvishoma nezvishoma tichidzokorora modhi iyi pasi rose, tichigara tichisimbisa musika wedu wekunze.
Haier Biomedical iri kusimudzirawo kuwedzera kwezvigadzirwa zvitsva, zvinosanganisira zviridzwa zvemurabhoritari, zvinodyiwa, uye akangwara pharmacy, kuwedzera kukwikwidza kwemamiriro edu ekugadzirisa.Kune vashandisi vesainzi yehupenyu, ma centrifuges edu akaita budiriro muEurope neAmerica, maomese echando awana maodha ekutanga muAsia, uye makabati edu ebiosafety apinda mumusika wekumabvazuva kweEurope.Zvichakadaro, zvigadzirwa zvedu zvemurabhoritari zvakawanikwa uye zvakadzokororwa muAsia, North America, uye Europe.Kumasangano ekurapa, kunze kwemishonga yekudzivirira kwezuva, mafiriji emishonga, nzvimbo dzekuchengetera ropa, uye zvinodyiwa zviri kukurawo nekukurumidza.Kuburikidza nekuenderera mberi nekudyidzana nemasangano epasirese, Haier Biomedical inopa masevhisi anosanganisira kuvaka marabhoritari, kuongororwa kwezvakatipoteredza uye sterilization, kugadzira mikana mitsva yekukura.
Pakupera kwa2023, anopfuura mazana mana emhando dzeHaier Biomedical dzakapihwa zvitupa mhiri kwemakungwa, uye dzakabudirira kuendeswa kumapurojekiti akati wandei muZimbabwe, Democratic Republic of Congo, Ethiopia, neLiberia, pamwe neChina-Africa Union Centers of Disease Control. (CDC) purojekiti, ichiratidza kuvandudzwa kwekuita kwekutumira.Zvigadzirwa zvedu uye zvigadziriso zvave zvakagamuchirwa zvakanyanya munyika dzinopfuura 150 nematunhu.Panguva imwecheteyo, takachengeta kubatana kwenguva refu nemasangano anopfuura makumi matanhatu epasi rose, kusanganisira World Health Organisation (WHO) neUNICEF.
Kuwana FDA 21 CFR Chikamu 11 chitupa chiitiko chakakosha cheHaier Biomedical apo isu tinotarisisa hunyanzvi murwendo rwedu rwekuwedzera kwenyika.Zvinoratidzawo kuzvipira kwedu kuzadzisa zvido zvevashandisi kuburikidza nehunyanzvi.Tichitarisa kumberi, Haier Biomedical ichaenderera mberi yedu mushandisi-centric innovation maitiro, kufambisira mberi hurongwa hwedu hwepasirese kutumirwa munzvimbo dzese, chiteshi, uye zvikamu zvechigadzirwa.Nekusimbisa hutsva hwemuno, tinovavarira kuongorora misika yepasi rose nehungwaru.
Nguva yekutumira: Jul-15-2024
