Shanghai IVEN Pharmatech Engineering Co., Ltd.
IVEN Pharmatech Engineering yog lub tuam txhab kev lag luam thoob ntiaj teb uas muab kev kho mob kev lag luam daws teeb meem. Peb muab kev daws teeb meem engineering rau thoob ntiaj teb cov chaw tsim tshuaj thiab chaw kho mob hauv kev ua raws li EU GMP / US FDA cGMP, WHO GMP, PIC / S GMP txoj cai thiab lwm yam. Nrog rau ntau xyoo dhau los hauv kev lag luam tshuaj thiab kev kho mob, peb mob siab rau xa tus neeg muag khoom txaus siab. -ua kev daws teeb meem rau peb cov neeg siv khoom thoob ntiaj teb, uas suav nrog kev tsim cov phiaj xwm qib siab, cov khoom siv zoo, kev tswj cov txheej txheem, thiab kev pabcuam tag nrho lub neej.
Peb yog leej twg?
IVEN tau tsim nyob rau xyoo 2005 thiab tau cog lus rau hauv kev lag luam tshuaj thiab kev kho mob, peb tau tsim plaub cov nroj tsuag uas tsim cov tshuaj filling thiab ntim tshuab, tshuaj dej kho tshuab, ntse conveying thiab logistic system. peb muab ntau txhiab tus kws kho mob thiab cov khoom siv kho mob thiab cov phiaj xwm tig, ua haujlwm ntau pua tus neeg siv khoom los ntawm ntau dua 50 lub teb chaws, pab peb cov neeg siv khoom txhim kho lawv cov kws kho mob thiab kev tsim muaj peev xwm, yeej qhov kev lag luam thiab lub npe zoo hauv lawv lub khw.
Peb Ua Dab Tsi?
Raws li cov neeg siv khoom xav tau los ntawm ntau lub teb chaws, peb hloov kho cov kev daws teeb meem kev sib xyaw ua ke rau cov tshuaj txhaj tshuaj pharma, khoom siv tshuaj pharma, tshuaj lom neeg lub cev, khoom siv kho mob, thiab kev cog qoob loo. Peb cov kev daws teeb meem kev lag luam suav nrog chav huv huv, kev siv dej huv, kev siv tshuaj kho dej, cov txheej txheem tsim khoom, kev siv tshuaj automation, packing system, ntse logistics system, kev tswj xyuas zoo, hauv nruab nrab chav kuaj thiab lwm yam. Raws li cov neeg siv khoom xav tau tus kheej, IVEN tuaj yeem muab cov kev pabcuam tshaj lij raws li hauv qab no:
* Qhov project feasibility kev sab laj
* Qhov project engineering tsim
* Cov khoom siv qauv xaiv thiab customization
* Kev teeb tsa thiab commissioning
* Kev lees paub ntawm cov khoom siv thiab txheej txheem
* Kev Tswj Xyuas Kev Pabcuam Zoo
* Ntau lawm technology hloov
* Cov ntaub ntawv nyuaj thiab mos
* Kev cob qhia rau cov neeg ua haujlwm
* Kev pab cuam tom qab muag tag nrho
* Production trusteeship
* Txhim kho kev pabcuam thiab lwm yam.
Vim Li Cas Peb?
Tsim tus nqi rau cov neeg siv khoomyog qhov tseem ceeb ntawm Iven lub neej, nws tseem yog cov lus qhia ua haujlwm rau tag nrho peb cov tswv cuab Iven. Peb lub tuam txhab tau ua haujlwm rau cov neeg siv khoom thoob ntiaj teb rau ntau tshaj 16 xyoo, peb tuaj yeem nkag siab peb cov neeg siv khoom thoob ntiaj teb kev xav tau zoo heev, thiab ib txwm muab cov cuab yeej zoo thiab qhov project rau cov neeg siv khoom nrog tus nqi tsim nyog.
Peb cov kws tshaj lij muaj ntau xyoo dhau los hauv kev lag luam tshuaj thiab kev kho mob, paub txog feem ntau ntawm cov kev xav tau thoob ntiaj teb GMP, xws li EU GMP / US FDA cGMP, WHO GMP, PIC / S GMP txoj cai thiab lwm yam.
Peb pab neeg ua haujlwm engineering yog kev ua haujlwm nyuaj thiab ua haujlwm tau zoo, muaj kev paub nplua nuj rau ntau hom kev lag luam, peb tsim cov phiaj xwm zoo tsis tsuas yog xav txog cov neeg siv khoom xav tau tam sim no, tab sis kuj tseem xav txog cov neeg siv khoom yav tom ntej txhua hnub khiav cov nqi txuag thiab kev saib xyuas yooj yim, txawm tias yav tom ntej expansion.
Peb pab neeg muag khoom tau txais kev kawm zoo uas muaj lub zeem muag thoob ntiaj teb thiab kev paub txog kev lag luam tshuaj, muab cov neeg siv khoom zoo thiab kev pabcuam zoo los ntawm kev muag khoom ua ntej mus rau theem tom qab muag nrog lub luag haujlwm thiab lub luag haujlwm.
Engineering Case
Koj puas muaj cov teeb meem hauv qab no?
• Cov ntsiab lus tseem ceeb ntawm daim ntawv thov tsim tsis yog qhov tseem ceeb, qhov kev teeb tsa tsis tsim nyog.
• Kev tsim kom tob tob tsis yog tus qauv, kev siv tau yooj yim.
• Kev kawm tiav ntawm qhov kev tsim qauv tsis muaj kev tswj hwm, lub sijhawm tsim kho tsis muaj qhov kawg.
• Qhov zoo ntawm cov cuab yeej tsis tuaj yeem paub txog txog thaum ua tsis tiav.
• Nws nyuaj rau kwv yees tus nqi kom poob nyiaj.
• Siv sijhawm ntau ntawm kev mus ntsib cov neeg muag khoom, sib tham txog kev tsim qauv thiab kev tswj xyuas kev tsim kho, sib piv ib qho tom qab ib zaug ntxiv.
Iven muab kev daws teeb meem engineering rau thoob ntiaj teb cov chaw muag tshuaj thiab chaw kho mob suav nrog chav huv huv, kev tswj hwm nws tus kheej thiab kev saib xyuas, kev kho dej tshuaj, kev daws teeb meem kev npaj thiab xa tawm, ntim thiab ntim qhov system, tsis siv neeg logistics system, kev tswj xyuas zoo thiab lub hauv paus chaw kuaj mob thiab thiab lwm yam raws li kev lag luam kws tshuaj cov kev cai ntawm cov teb chaws sib txawv thiab cov neeg siv khoom xav tau, IVEN ua tib zoo kho cov kev daws teeb meem engineering ntawm turnkey project thiab pab peb cov neeg siv khoom yeej lub koob npe nrov thiab cov xwm txheej hauv cov ntaub ntawv ntawm kev lag luam tshuaj hauv tsev.
Peb lub Hoobkas
Pharmaceutical Machinery:
Peb R & D muaj peev xwm ntawm Pharmaceutical machinery rau IV kua series cov khoom yog nyob rau hauv ib tug kiag li ua theem nyob rau hauv domestic thiab advanced qib thoob ntiaj teb. Nws tau thov rau ntau tshaj 60 kev patents, nws tuaj yeem muab tag nrho cov ntaub ntawv pom zoo rau cov neeg siv khoom pom zoo thiab GMP daim ntawv pov thawj. Peb lub tuam txhab tau muag ntau pua lub hnab mos IV cov kab ntau lawm kom txog rau thaum xaus ntawm 2014, nws suav txog 50% ntawm kev ua lag luam; iav raj mis IV tov ntau lawm kab tso nyiaj rau ntau tshaj 70% kev ua lag luam nyob rau hauv Suav teb. Lub raj mis yas IV cov kab ntau lawm kuj tau muag rau Central Asia thiab Southeast Asia thiab lwm yam. Nws tau txais kev qhuas los ntawm txhua tus neeg siv khoom. Peb lub tuam txhab tau tsim kev lag luam zoo kev sib raug zoo nrog ntau tshaj 300 IV cov tuam txhab lag luam hauv Suav teb, thiab tau txais lub koob npe zoo hauv Uzbekistan, Pakistan, Negeria thiab 30 lwm lub teb chaws. Peb tau dhau los ua neeg nyiam Suav hom thaum thoob ntiaj teb IV cov chaw tsim khoom lag luam yuav khoom.Our chaw tsim tshuaj machinery yog ib qho ntawm cov tswv cuab tseem ceeb ntawm Tuam Tshoj Pharmaceutical Equipment Association, National Technical Committee on Pharmaceutical Equipment Standardization, thiab cov chaw tsim tshuaj paus ntawm Pharmaceutical Production Machinery hauv Suav teb. Peb nruj me ntsis tswj cov tshuab zoo, raws li ISO9001: 2008, ua raws li cGMP, European GMP, US FDA GMP thiab WHO GMP cov qauv thiab lwm yam.
Peb tau tsim cov khoom siv los ua kom tau raws li qhov yuav tsum tau ua, xws li Non-PVC Mos Hnab / PP lub raj mis / iav fwj IV cov tshuaj ntau lawm kab, tsis siv neeg ampoule / vial ntxhua- filling-sealing ntau lawm kab, qhov ncauj kua ntxhua- ziab-filling- sealing ntau lawm kab, dialysis kua filling-sealing ntau lawm kab, prefilled syringe filling-sealing ntau lawm kab thiab lwm yam.
Cov cuab yeej kho dej:
Nws yog lub tuam txhab high-tech tshwj xeeb hauv R & D thiab tsim RO chav rau Purified Dej, ntau qhov cuam tshuam dej distiller system rau Dej Rau Kev Txhaj Tshuaj, purified steam generator, cov tshuaj npaj cov tshuab, txhua yam dej thiab cov tshuaj cia tank, thiab cov tshuab xa tawm. .
Peb muab cov cuab yeej zoo tsim thiab tsim khoom raws li GMP, USP, FDA GMP, EU GMP thiab lwm yam.
Auto Packing and Warehouse System & Facilities Plant:
Raws li tus thawj coj tsim khoom rau logistic thiab tsis siv neeg ntse kev sib koom ua ke warehouse system, peb tsom mus rau qhov pib ntim khoom thiab cov khoom siv hauv tsev R & D, tsim, tsim, engineering thiab kev cob qhia.
Muab cov neeg muas zaub tag nrho cov kev sib koom ua ke los ntawm Auto Packing rau Warehouse WMS & WCS engineering nrog cov kev pabcuam zoo thiab cov kev pabcuam zoo, xws li robotic carton packing machine, full automatic carton unfolding machine, Automatic logistics system and Automatic three-dimensional warehouse system etc.
Nrog rau cov kev daws teeb meem zoo tshaj plaws, peb cov haujlwm thiab cov khoom lag luam tau siv dav hauv kev lag luam tshuaj, khoom noj khoom haus, hluav taws xob kev lag luam thiab kev lag luam logistics thiab lwm yam.
Nqus Ntshav Sau Tube Machinery Cog:
Peb tsom mus rau qhov zoo, muaj txiaj ntsig, ua tau zoo thiab khov kho cov khoom ntim cov hlab ntsha thiab cov khoom siv tsis siv neeg cuam tshuam. Peb tau txais kev siv tshuab nqus ntshav siab tshaj plaws hauv 20 xyoo dhau los, thiab peb tau tsim ntau tiam neeg ntawm Lub Nqus Tsev Ntshav Collection Tube Production Lines, uas txhawb nqa lub tshuab nqus ntshav sau cov khoom lag luam mus rau qib siab thoob ntiaj teb.
Peb ua haujlwm zoo ntawm cov khoom lag luam zoo thiab kev tsim kho tshiab, peb tau ua tiav ntau tshaj 20 patents rau cov khoom siv hluav taws xob ntau lawm. Peb txhim kho cov cuab yeej thev naus laus zis tsis tu ncua thiab dhau los ua tus thawj coj thiab tus tsim ntawm Tuam Tshoj cov ntshav sau raj tsim khoom lag luam.
Oversea Projects
Txog tam sim no, peb twb tau muab ntau pua cov khoom siv tshuaj thiab khoom siv kho mob rau ntau tshaj 40 lub teb chaws. Lub caij no, peb tau pab peb cov neeg muas zaub los tsim cov tshuaj thiab kev kho mob cog nrog turnkey tej yaam num nyob rau hauv Uzbekistan, Tajikistan, Indonesia, Thaib teb, Saudi, Iraq, Nigeria, Uganda thiab lwm yam. Tag nrho cov tej yaam num yeej peb cov neeg muas zaub thiab lawv tsoom fwv cov lus siab.
Central Asia
Hauv tsib lub tebchaws Esxias Central, feem ntau ntawm cov khoom siv tshuaj yog tuaj ntawm txawv teb chaws, tsis hais txog kev txhaj tshuaj. Tom qab ob peb xyoos ntawm kev ua haujlwm hnyav, peb twb tau pab lawv tawm ntawm qhov teeb meem ib zaug. Nyob rau hauv Kazakhstan, peb tsim ib tug loj kev koom ua ke kws tshuaj Hoobkas uas muaj xws li ob lub hnab mos IV-Solution Production Lines thiab plaub Ampoules Txhaj Tshuaj Ntau Lawm Kab.
Hauv Uzbekistan, peb tau tsim lub PP Lub raj mis IV-Solution Pharmaceutical Factory, uas tuaj yeem tsim tau 18 lab lub raj mis txhua xyoo. Lub Hoobkas tsis tsuas yog coj lawv cov txiaj ntsig nyiaj txiag ntau tab sis kuj muab cov txiaj ntsig zoo rau cov neeg hauv zos rau kev kho tshuaj.
Teb chaws Africa
Teb chaws Africa nrog cov pej xeem coob, nyob rau hauv uas kev lag luam tshuaj hauv paus tseem tsis muaj zog, xav tau kev txhawj xeeb ntxiv. Tam sim no, peb tab tom tsim Soft Bag IV-Solution Pharmaceutical Factory hauv Nigeria, uas tuaj yeem tsim tau 20 lab lub hnab mos hauv ib xyoos. Peb yuav txuas ntxiv tsim cov chaw tsim tshuaj ntau dua hauv tebchaws Africa, thiab peb xav kom cov neeg hauv zos hauv tebchaws Africa tuaj yeem tau txais txiaj ntsig zoo los ntawm kev siv cov khoom lag luam zoo hauv tsev.
Middle East
Rau Middle East, kev lag luam tshuaj tsuas yog nyob rau theem pib, tab sis lawv tau xa mus rau USA FDA nrog cov tswv yim siab tshaj plaws thiab cov qauv siab tshaj plaws los saib xyuas lawv cov tshuaj zoo thiab cov chaw muag tshuaj. Ib qho ntawm peb cov neeg siv khoom los ntawm Saudi Arabia tau tshaj tawm ib qho kev txiav txim rau peb rau kev ua tag nrho Cov Hnab Muag Khoom IV-Kev daws teeb meem Turnkey Project rau lawv, uas tuaj yeem tsim ntau dua 22 lab lub hnab mos txhua xyoo.
Hauv lwm lub tebchaws Esxias, kev lag luam tshuaj tau tsim lub hauv paus, tab sis nws tseem tsis yooj yim rau lawv los tsim lub Hoobkas IV-Solution zoo. Ib qho ntawm peb cov neeg siv khoom Indonesian kuj, tom qab sib tw ntawm kev xaiv, xaiv peb, uas ua cov txheej txheem muaj zog tshaj plaws, los tsim lub tsev lag luam qib siab IV-Solution Pharmaceutical Factory hauv lawv lub tebchaws. Peb tau ua tiav lawv cov theem 1 turnkey project nrog 8000 fwj / teev uas khiav zoo. Thiab lawv theem 2 nrog 12000 fwj / teev, peb yuav pib lub installation thaum lig 2018.
PEB TEAM
• Raws li ib pab neeg tshaj lij muaj ntau tshaj 10 xyoo kev paub thiab cov khoom siv hauv kev lag luam Pharmaceutical, feem ntau ntawm kev yuav khoom yog cov khoom zoo, Cov nqi sib tw, tus nqi siab thiab tau txais txiaj ntsig.
• Nrog kev tswj xyuas kev ua haujlwm thiab kev ruaj ntseg zoo, peb cov qauv tsim thiab kev tsim kho tau ua raws li FAD, GMP, ISO9001 thiab 14000 cov txheej txheem zoo, Cov cuab yeej siv tau zoo heev thiab feem ntau siv tau ntau tshaj 15 xyoo.(Stainless steel khoom muaj rau ntau tshaj 20 xyoo. )
• Peb pab neeg tsim qauv coj los ntawm ntau tus kws tshaj lij hauv kev lag luam Pharmaceutical nrog lub peev xwm zoo tshaj plaws, kev txawj ntse hauv kev sib sib zog nqus, cov ntsiab lus ntxiv dag zog, Ua tiav lav qhov kev ua tau zoo ntawm qhov project.
• Nrog rau kev ua tib zoo xam, kev npaj tsim nyog thiab tus nqi accounting tshwj xeeb systematization, scale tswj thiab optimize tus nqi ntawm kev ua hauj lwm, yog li xyuas kom meej cov lag luam muaj txiaj ntsim zoo.
• Nrog pab pawg neeg ua haujlwm pabcuam txhawb nqa online thiab offline hauv ntau hom lus, xws li: Lus Askiv, Lus Mev, Fabkis, ect, yog li ua kom muaj kev pabcuam zoo thiab ua haujlwm tau zoo.
• Ntau tshaj 10 xyoo dhau los ntawm txoj haujlwm turnkey hauv Pharmaceutical teb nrog kev txawj ntse heev ntawm kev teeb tsa thiab kev tsim kho, cov haujlwm tau ua raws li FDA, GMP thiab European Union thiab lwm yam pov thawj.
Qee tus ntawm peb cov neeg siv khoom
ZOO TSHAJ PLAWS ua haujlwm uas peb pab pawg tau koom tes rau peb cov neeg siv khoom!
Tuam txhab Certificate
CE
FDA
FDA
ISO 9001 Cov
Project Case Presentation
Peb tau xa tawm ntau pua cov khoom siv mus rau ntau tshaj 40 lub teb chaws, kuj tau muab ntau tshaj kaum qhov kev lag luam turnkey thiab ntau txoj haujlwm kho mob turnkey. Nrog rau kev siv zog zoo txhua lub sijhawm, peb tau txais peb cov neeg siv khoom cov lus pom zoo thiab tsim lub koob npe nrov hauv International lag luam maj mam.
Kev cog lus rau kev pabcuam
Kuv Ua Ntej Muag Kev Pabcuam
1. Koom nrog hauv kev npaj ua haujlwm ntawm qhov project thiab muab cov lus qhia siv nyob rau hauv ncav cuag thaum tus neeg yuav khoom pib ua cov phiaj xwm phiaj xwm thiab xaiv hom khoom siv.
2. Xa cov kws tshaj lij kev txawj ntse thiab cov neeg ua haujlwm muag khoom kom ua tiav kev sib txuas lus sib sib zog nqus nrog cov khoom siv ntawm tus neeg yuav khoom thiab muab cov khoom siv thawj zaug xaiv kev daws teeb meem.
3. Muab cov txheej txheem flowchart, cov ntaub ntawv technical thiab chaw teeb tsa ntawm cov khoom siv cuam tshuam rau tus neeg yuav khoom rau nws tus qauv tsim ntawm lub Hoobkas.
4. Muab ib qho piv txwv engineering ntawm lub tuam txhab rau tus neeg yuav khoom siv thaum xaiv hom thiab tsim. Ib txhij muab cov khoom muaj feem xyuam ntawm engineering piv txwv rau kev sib pauv kev.
5. Tshawb xyuas qhov chaw tsim khoom thiab cov txheej txheem ntws ntawm lub tuam txhab. Muab cov ntaub ntawv ntsig txog kev tswj xyuas logistic thiab kev tswj xyuas qhov zoo.
II Project Management hauv Kev Muag Khoom
1. Hais txog qhov project nrog nws daim ntawv cog lus kos npe, lub tuam txhab ua cov kev tswj xyuas qhov project uas npog tag nrho cov txheej txheem los ntawm kev kos npe rau daim ntawv cog lus mus rau qhov kawg daim tshev thiab kev lees paub ntawm qhov project. Cov kauj ruam yooj yim yog raws li hauv qab no: kev kos npe rau daim ntawv cog lus, kev txiav txim siab hauv pem teb, kev tsim khoom thiab kev ua haujlwm, kev sib dhos me me thiab kev debugging, kev sib dhos zaum kawg, kev tshuaj xyuas tus me nyuam, khoom siv shipping, davhlau ya nyob twg debugging, check thiab txais.
2. Lub tuam txhab yuav xaiv ib tus kws tshaj lij uas muaj kev paub dhau los hauv kev tswj hwm qhov project raws li tus neeg saib xyuas, uas yuav ua lub luag haujlwm tag nrho rau kev tswj xyuas qhov project thiab kev sib tham. Tus neeg yuav khoom yuav tsum paub meej tias cov khoom ntim thiab tawm ib qho qauv. Tus neeg yuav khoom yuav tsum tau muab cov khoom siv rau kev tsav tsheb thaum lub sij hawm sib dhos thiab debugging rau tus neeg muag khoom dawb.
3. Kev kuaj xyuas ua ntej thiab kev lees paub ntawm cov khoom siv tuaj yeem nqa tawm hauv lub Hoobkas lossis tus neeg yuav khoom lub Hoobkas. Yog tias daim tshev thiab kev lees txais tau ua nyob rau hauv lub chaw muag khoom lub Hoobkas, tus neeg yuav khoom yuav tsum xa cov neeg mus rau lub chaw muag khoom lub Hoobkas rau kev kuaj xyuas thiab kev lees txais tsis pub dhau 7 hnub ua haujlwm tom qab tau txais kev ceeb toom ntawm cov khoom tsim ua tiav los ntawm tus neeg muag khoom. Yog tias qhov kev kuaj xyuas thiab kev lees paub tau ua tiav hauv tus neeg yuav khoom lub Hoobkas, cov cuab yeej yuav tsum tau muab tshem tawm thiab kuaj xyuas nrog cov khoom ntawm tus neeg muag khoom thiab tus neeg yuav khoom hauv 2 hnub ua haujlwm tom qab cov khoom tuaj txog. Daim ntawv txheeb xyuas thiab lees txais yuav tsum ua tiav.
4. Cov txheej txheem kev teeb tsa cov cuab yeej yog txiav txim siab los ntawm kev pom zoo ntawm ob tog. Nws cov neeg ua haujlwm debugging yuav coj kev teeb tsa raws li daim ntawv cog lus thiab ua tiav kev cob qhia rau cov neeg siv kev khiav hauj lwm thiab tu cov neeg ua haujlwm.
5. Ntawm qhov xwm txheej uas cov khoom siv dej, hluav taws xob, roj thiab cov khoom siv debugging tau muab, tus neeg yuav khoom tuaj yeem ceeb toom rau hauv daim ntawv sau rau tus neeg muag khoom kom xa cov neeg ua haujlwm rau cov khoom siv debugging. Cov nqi dej, hluav taws xob, roj thiab cov khoom siv debugging yuav tsum tau them los ntawm tus neeg yuav khoom.
6. Kev debugging yog nqa tawm hauv ob theem. Cov cuab yeej raug teeb tsa thiab cov kab tau muab tso rau hauv thawj theem. Hauv theem thib ob, kev debugging thiab kev tsav tsheb khiav yog ua raws li qhov xwm txheej uas tus neeg siv lub tshuab cua txias tau huv thiab muaj dej, hluav taws xob, roj thiab cov khoom siv debugging.
7. Hais txog kev kuaj xyuas zaum kawg thiab kev lees paub, qhov kev xeem zaum kawg yog ua raws li daim ntawv cog lus thiab phau ntawv qhia ntawm cov khoom siv nyob rau hauv lub xub ntiag ntawm ob tus neeg muag khoom tus neeg ua haujlwm thiab tus neeg yuav khoom tus neeg saib xyuas. Daim ntawv ntsuam xyuas zaum kawg thiab kev lees txais yuav raug sau thaum qhov kev xeem zaum kawg tiav.
III Cov ntaub ntawv qhia txuj ci muab
I) Cov ntaub ntawv tsim nyog rau kev teeb tsa (IQ)
1. Daim ntawv pov thawj zoo, phau ntawv qhia, packing list
2. Shipping daim ntawv teev npe, daim ntawv teev cov khoom hnav, ceeb toom rau kev debugging
3. Daim duab kos duab (nrog rau cov khoom siv kos duab kos duab, kev sib txuas cov yeeb nkab qhov chaw kos duab, kos duab qhov chaw ntawm qhov chaw, hluav taws xob schematic daim duab, daim duab tsav tsheb, phau ntawv qhia rau kev teeb tsa thiab hoisting)
4. Kev khiav hauj lwm phau ntawv rau cov khoom tseem ceeb yuav
II) Cov ntaub ntawv kev ua tau zoo (PQ)
1. Lub Hoobkas tshuaj xyuas daim ntawv qhia txog kev ua haujlwm tsis zoo
2. Txais daim ntawv pov thawj rau ntsuas
3. Daim ntawv pov thawj ntawm cov khoom tseem ceeb ntawm lub tshuab tseem ceeb
4. Cov qauv tam sim no ntawm cov qauv kev lees paub ntawm cov khoom
III) Cov ntaub ntawv tsim nyog ua haujlwm (OQ)
1. Cov qauv ntsuas rau cov cuab yeej technical parameter thiab Performance index
2. Cov txheej txheem kev khiav hauj lwm, txheej txheem txheej txheem yaug
3. Cov txheej txheem rau kev tu thiab kho
4. Cov qauv rau cov khoom siv tsis zoo
5. Cov ntaub ntawv tsim nyog rau kev teeb tsa
6. Cov ntaub ntawv tsim nyog ua haujlwm
7. Pilot khiav cov ntaub ntawv tsim nyog
IV) Kev txheeb xyuas cov cuab yeej ua haujlwm
1. Basic functional verification (kos rau loaded kom muaj nuj nqis thiab clarity)
2. Txheeb xyuas qhov ua tau zoo ntawm cov qauv thiab kev tsim khoom
3. Kev xeem ua haujlwm rau kev tswj tsis siv neeg xav tau
4. Muab cov kev daws teeb meem ua kom tiav cov cuab yeej ua kom tau raws li GMP pov thawj
IV Kev Pabcuam Tomqab Muag
1. Tsim cov ntaub ntawv cov neeg siv khoom, khaws cov khoom siv tsis muaj kev cuam tshuam ntawm cov khoom seem, thiab muab tswv yim rau cov neeg siv khoom kev hloov kho thiab hloov kho.
2. Tsim cov txheej txheem ua raws. Mus ntsib cov neeg siv khoom ib ntus thaum cov cuab yeej teeb tsa thiab kev debugging tiav los pub rov qab siv cov ntaub ntawv hauv lub sijhawm kom paub meej lub suab, ruaj khov thiab txhim khu kev qha ntawm cov khoom siv thiab tshem tawm cov neeg siv khoom txhawj xeeb.
3. Ua cov lus teb tsis pub dhau 2 teev tom qab tau txais cov neeg yuav khoom qhov kev ceeb toom tsis ua hauj lwm lossis kev pabcuam. Npaj cov neeg ua haujlwm saib xyuas kom ncav cuag qhov chaw hauv 24 teev, thiab 48 teev ntawm qhov tseeb.
4. Lub sijhawm lav zoo: 1 xyoo tom qab kev lees paub cov khoom siv. "Peb qhov kev lees paub" tau ua thaum lub sijhawm lav zoo suav nrog: lav kev kho (rau lub tshuab ua tiav), lav kev hloov pauv (rau cov khoom hnav tshwj tsis yog cov neeg tsim kev puas tsuaj), thiab lav nyiaj rov qab (rau cov khoom xaiv tau).
5. Tsim kom muaj kev pabcuam kev tsis txaus siab. Nws yog peb lub hom phiaj kawg los pab peb cov neeg siv khoom zoo dua thiab lees txais kev saib xyuas ntawm peb cov neeg siv khoom. Peb yuav tsum tso siab rau qhov tshwm sim uas peb cov neeg ua haujlwm nrhiav kev them nyiaj thaum lub sijhawm teeb tsa, kev debugging thiab kev pabcuam.
V Training Program rau Kev Ua Haujlwm thiab Kev Tu
1. Lub hauv paus ntsiab lus ntawm kev cob qhia yog "siab kom muaj nuj nqis, siab zoo, ceev ceev thiab txo nqi". Qhov kev cob qhia yuav tsum ua haujlwm rau kev tsim khoom.
2. Hoob kawm: chav kawm theoretical thiab chav xyaum ua. Cov chav kawm theoretical feem ntau yog hais txog cov khoom siv ua haujlwm, cov qauv, cov yam ntxwv ntawm kev ua haujlwm, kev siv ntau yam, kev ceev faj txog kev ua haujlwm, thiab lwm yam. Txoj kev qhia ntawm cov tub ntxhais kawm tau txais kev pom zoo rau cov tub ntxhais kawm ua haujlwm sai sai rau kev ua haujlwm, kev saib xyuas txhua hnub, kev debugging thiab kev daws teeb meem. cov khoom siv thiab hloov thiab hloov kho ntawm qhov chaw teev tseg.
3. Cov Xib Fwb: Kev tsim khoom loj ntawm cov khoom thiab cov kws paub txog kev paub
4. Cov neeg ua haujlwm: Cov neeg ua haujlwm, cov neeg ua haujlwm tu thiab cov neeg ua haujlwm tswj xyuas los ntawm tus neeg yuav khoom.
5. Kev cob qhia hom: Kev cob qhia kev cob qhia yog nqa tawm ntawm cov khoom siv fabrication site ntawm lub tuam txhab thawj zaug, thiab kev cob qhia kev cob qhia yog nqa tawm ntawm qhov chaw tsim khoom ntawm tus neeg siv thib ob.
6. Lub sijhawm cob qhia: Nyob ntawm qhov ua tau zoo ntawm cov khoom siv thiab cov neeg ua haujlwm
7. Kev cob qhia tus nqi: Muab cov ntaub ntawv qhia kev kawm pub dawb thiab pab txhawb cov tub ntxhais kawm dawb thiab tsis them tus nqi kawm.