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Monitoring yekuona muchina wemabhechi TVS inogonesa zviratidzo zvemhando yepiritsi uye kushanda kwemushini wepiritsi wepiritsi kunyatsotariswa uye nekunyatsotariswa nguva dzese, kuona matambudziko nenguva, nekukasira svinura uye kuparadzanisa zvikamu zvine njodzi zvechigadzirwa.Monitoring yekuona muchina wemabatches TVS inogonesa kutarisa kure kunzvimbo yekugadzira, chaiyo-nguva kunzwisisa kwezviri kuitika panzvimbo yekugadzira, uye clairance-kuona uye mhepo-tunnel nzeve dzekugadzira uye yemhando manejimendi vashandi.
Seseti yemhando ine simba yekutonga system, yekutarisa yekuona muchina wemabhechi TVS ndiyo nzira yekudzora yemhando yekugadzira piritsi, chishandiso chine simba chekutsvaga matambudziko pakutanga uye kubatsira vashandi vekugadzira kuti vawane matambudziko nekukurumidza, chishandiso chinoshanda cheSPC mhando. manejimendi pfungwa, uye vimbiso inoshanda yemhando yechigadzirwa.
Kukosha kune vashandisi
1. Monitoring yekuona muchina wemabatches TVS yakabatana nekapule yekuzadza muchina uye piritsi rekudhinda muchina, sampling zvisingaite zvinoenderana nenguva yakarongwa, inogona kutariswa maawa makumi maviri nemana pazuva, huremu hwekapisi uye piritsi hauzoratidzike zvisina kujairika, nekuti kana yangoonekwa. zvisina kujairika, inozowanikwa nekukasira, CVS ichaita alarm yekuyeuchidza, uye panguva imwe chete, kune njodzi dzezvikamu zvechigadzirwa zvakabva zvaparadzaniswa, saka zvakanyatsotariswa iyo CVS mumaawa makumi maviri nemana, ingave mhando yechigadzirwa, kana kugadzirwa kwemidziyo inoshanda, zvose zviri muchimiro chinodzoreka, kwete chinetso.
2. Yese huremu hwezviyo data yehwendefa ndeyechokwadi uye yakavimbika, uye iyo nhamba yeruzivo yakadzama uye yakarekodhwa zvachose, inogona kubvunza inogona kudhinda, iyo sampuli yekuyera rekodhi yehuremu hwezviyo yakadhindwa papepa ine ruzivo rwakakwana uye data rakadzama, rinogona kuve rakananga se marekodhi ekugadzirwa kwebatch, izvo zvakaipira zvemanyorero sampling kuyera uye kurekodha zvinoregererwa, zvakaderedza zvakanyanya kusimba kwebasa remushandisi, kuita kuti mushonga wemhando yemishonga uwedzere padanho idzva.
3. Panyaya yekufamba kwenguva uye kubudirira kwekutonga kwengozi uye kutonga, kuonekwa kwezvikwata uye basa rekuzviparadzanisa rekutarisa kuona muchina we batch TVS, inogona kuderedza dambudziko rehuwandu kusvika pachiyero chiduku, chinogona kuderedza tsvina yezvinhu kusvika pachiyero chiduku.
4. Panyaya yekuteerera, muchina wekuona mabhechi eTVS unosangana nezvinodiwa zvakanyanya zvecGMP neGMAP5, zvinonyatsoenderana nemitemo yese yeUS FDA 21CFR-PART11, inosangana nezvinodiwa zvese zvekuvimbika kwedata, uye data yemagetsi yakanakira kurongeka kwemhando uye kuongororwa kwekuongorora.
5. Monitoring yekuona muchina wemabhechi mabasa ane simba eTVS uye kutarisa kure kunoita kuti kugadzirwa uye kutarisisa kwemhando kuve nyore uye kunoshanda.CVS haingori chishandiso chinoshanda chekuvandudza mhando uye kuona SPC nhamba yemaitiro ekudzora mhando yezvinodhaka, asiwo inodiwa nzvimbo yehardware yemabhizinesi kusimudzira kugadzira uye kuona ekugadzira uye isina kurongwa mashopu.
Tumira meseji yako kwatiri:
Nguva yekutumira: Sep-03-2020