Nrog Koj Txhua Kauj Ruam Ntawm Txoj Kev
Txhawm rau ua raws li EN 1422 – EN ISO 11135, ISO 13485 Cov Qauv, thiab GMP cov lus qhia, peb cov txheej txheem thiab cov txheej txheem tsim los pab koj ua raws validation yuav tsum thiab ua tau raws li koj yuav tsum tau specifications.
URS (User Requirement Specifications)
Txhais cov kev xav tau kom ua tiav cov kev xav tau ntawm cov txheej txheem. Feem ntau, URS yuav tsum muaj rau eto sterilizer tshuab ua ntej ua tus tsim.
Txhawm rau ua kom tau raws li tus neeg siv yuav tsum tau ua, peb tau them nyiaj tshwj xeeb rau URS (Cov Neeg Siv Khoom Xav Tau) (xws li chamber loj, khoom, pob, EO feem pua, thiab lwm yam)
Tawm los ntawm: User
FDS (Functional Design Specifications)
Specification nyob rau hauv uas qhov kev xav tau ntawm tus neeg yuav khoom raug xa mus rau hauv kev daws teeb meem (los ntawm cov chaw tsim khoom qhov pom)
Tawm los ntawm: Chaw tsim tshuaj paus
TSEEM CEEB (DS)
Specification ntawm lub hauv paus txheej txheem thiab specification ntawm cov limiting yam uas yuav tsum tau txiav txim siab thaum lub sij hawm kev loj hlob, kev tsim kho thiab kev sib dhos. DS xyuas kom meej tias txhua tus neeg siv khoom xav tau thiab cov qauv siv tau tam sim no los ntawm CGMP, EU, EN ISO thiab FDA txaus siab.
FAT / SAT (Lub Hoobkas Txais Kev Xeem / Qhov Chaw Pom Zoo)
Cov ntaub ntawv lees paub kev xeem ntawm tus neeg xa khoom / cov neeg siv khoom nrog cov ntawv xeem, cov ntsiab lus xeem, cov npe ntawm cov teeb meem qhib, thiab tso tawm daim ntawv pov thawj.
Hauv BOCON, ua ntej kev muag khoom, lub Hoobkas muab cov neeg siv khoom tsim thiab kev sib tham ntawm tag nrho cov khoom siv thiab cov chaw ntawm ETO Rhiav thiab pab tsim cov kev npaj tag nrho thiab kev teeb tsa ntawm ETO Rhiav. Raws li cov yam ntxwv ntawm cov neeg siv khoom thiab cov khoom siv, cov khoom siv, ntim, kev thauj mus los, thiab kev txhim kho yav tom ntej, peb xaiv cov khoom siv, kev teeb tsa, kev tswj hom, ntim, thiab ntau npaum li cas rau lub sterilizer. Los pab hauv kev npaj cov txheej txheem ethylene oxide sterilization, cov txheej txheem pov thawj, ETO Rhiav kev tswj xyuas cov cai thiab cov kev cai, cov khoom siv thiab kev saib xyuas, thiab lwm yam. Nyob rau tib lub sij hawm muab cov qauv tsim, preheating, seem seem, kev sib tham txog kev siv tshuab, thiab kev koom tes.
DQ, IQ, OQ, PQ
DQ (Kev Tsim Nyog Tsim Nyog)
IQ (Installation Qualification)
OQ (Kev Tsim Nyog Ua Haujlwm)
PQ (Kev Kawm Txuj Ci)
Los ntawm cov khoom thiab cov kev xav tau tshwj xeeb, rau kev soj ntsuam kev pheej hmoo, mus rau kev npaj thiab ua tiav ntawm tus kheej cov kauj ruam tsim nyog, peb saib xyuas txhua yam kev siv yuav tsum tau ua.
Kev lees paub: BOCON yuav muab software validation. IQ, OQ daim ntawv qhia, thiab kev txhawb nqa ntawm PQ tom qab kev teeb tsa.
IR OQ PQ qhia
