FDA 21 CFR Part 11 Kev Ua Raws Li Txoj Cai
21 CFR Tshooj 11 tswj hwm thaum cov ntaub ntawv hluav taws xob thiab kos npe tuaj yeem suav tias yog sib npaug ntawm cov ntaub ntawv rau FDA- cov ntaub ntawv tswj hwm. Cov cuab yeej uas tsim GMP- cov txiaj ntsig tseem ceeb -TOC, CCIT, lim kev ncaj ncees, kev saib xyuas ib puag ncig- tab sis tsis muaj txoj hauv kev tshawb xyuas, kev tswj xyuas kev nyab xeeb, lossis cuam tshuam - cov ntaub ntawv pov thawj tuaj yeem ua rau muaj kev cuam tshuam lwm txoj hauv kev thaum lub sijhawm tshuaj xyuas FDA, txawm hais tias qhov kev sim hauv qab no zoo npaum li cas.
Txoj Cai Tswjfwm
FDA 21 CFR Part 11 teeb tsa cov kev cai rau kev tshawb xyuas txoj kev, kos npe hauv hluav taws xob, kev tswj xyuas kev nkag mus, thiab cov ntaub ntawv khaws cia rau cov ntaub ntawv hluav taws xob GMP. FDA cov lus qhia xyoo 2003 ntawm Tshooj 11 thiab daim ntawv thov txo qis kev ua haujlwm tsom mus rau cov ntaub ntawv pov thawj- txoj cai, tab sis kev tshawb xyuas txoj hauv kev thiab cov ntaub ntawv kev ntseeg siab tseem yog ib qho kev soj ntsuam zoo ib yam thoob plaws cov ntaub ntawv kev ntseeg siab tam sim no (FDA thiab MHRA ALCOA- ntxiv rau cov hauv paus ntsiab lus).
Peb cov kev daws teeb meem
Peb cov cuab yeej yog tsim nrogtag nrho cov ntaub ntawv soj ntsuam txoj kev, cim hluav taws xob kos npe, ntau- theem cov neeg siv nkag mus rau kev tswj hwm txoj cai thiab tamper- cov ntaub ntawv pov thawj encrypted exportraws li tus qauv nta es tsis them nyiaj ntxiv -ons, npogTOC tag nrho cov organic carbon analyzers, CCIT thawv kaw kev ntseeg siab testers, lim kev ntseeg siab testers, hnab looj tes ncaj ncees testers thiab airborne particle counters. Cov ntaub ntawv ncaj ncees yog tsim nyob rau hauv qib firmware kom cov ntaub ntawv nyoos, metadata, thiab kev tshawb xyuas txoj kev nyob twj ywm txuas thiab xa tawm ua ke. Raws li cov chaw tsim khoom peb muablub neej dawb firmware hloov tshiab rau Tshooj 11 muaj nuj nqi iteration, cheeb tsam-customized IQ/OQ/PQ validation document packages, ntawm-site technical support for computerized system validation (CSV), and long-term data integrity compliance consultation.
Cov khoom
RTP Integrity Tester WRTP-1000
Tau txais QUOTATION
Bag Integrity Tester
PEB-200
Tau txais QUOTATION
Wireless hnab looj tes Integrity Tester WGT-1200
Tau txais QUOTATION
Wireless hnab looj tes Integrity Tester WGT-2000
Tau txais QUOTATION
Tsis Siv Neeg Lim Kev Ncaj Ncees Tester V10
Tau txais QUOTATION
Online thiab Offline Total Organic Carbon Analyzer
Tau txais QUOTATION
Tag nrho Organic Carbon Analyzer TA-200
Tau txais QUOTATION
CCIT-Packaging Leak Tester MFT-900
Tau txais QUOTATION
FAQ
Q1: Puas yog 21 CFR Part 11 siv rau tag nrho cov cuab yeej kuaj?
A1: Nws siv tshwj xeeb rau cov ntaub ntawv hluav taws xob thiab cov ntawv kos npe siv los ua kom tau raws li FDA cov cai tswj hwm cov cai - lub ntsiab lus cov cuab yeej tsim GMP- cov ntaub ntawv tseem ceeb siv rau kev tso tawm lossis kev txiav txim siab ua raws li feem ntau nyob rau hauv.
Q2: ALCOA + yog dab tsi thiab nws cuam tshuam li cas rau Tshooj 11?
A2: ALCOA + (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available) yog cov ntaub ntawv kev ncaj ncees siv los ntawm cov neeg tswj xyuas los ntsuam xyuas seb cov ntaub ntawv hluav taws xob puas ua tau raws li Tshooj 11 lub hom phiaj, tsis yog nws cov ntawv txheeb xyuas xwb.
Q3: Ib qho cuab yeej uas twb muaj lawm puas tuaj yeem rov kho dua rau Tshooj 11 ua raws?
A3: Qee lub sij hawm, los ntawm kev hloov kho firmware ua rau kev tshawb xyuas txoj hauv kev thiab nkag mus tswj; kho vajtse qub uas tsis muaj kev ruaj ntseg cov ntaub ntawv architecture yuav xav tau kev hloov es tsis yog retrofit.
Q4: Dab tsi yog qhov sib txawv ntawm Ntu 11 feem ntau pom thaum kuaj FDA?
A4: Tsis muaj lossis tsis tiav cov kev tshuaj xyuas - tshwj xeeb tshaj yog muaj peev xwm qhia tau tias leej twg hloov pauv, tshem tawm, lossis rov ua dua cov txiaj ntsig, thiab thaum - yog ib feem ntawm cov ntaub ntawv feem ntau hais txog kev ncaj ncees.