Data Integrity & Digital Systems
Kev tswj cov ntaub ntawv lub neej, kev tswj hwm kev tswj hwm hauv computer, thiab kev tshuaj xyuas- kev qhuab qhia rau kev tswj hwm - ntsib biosafety thiab CMC kuaj.
Cov ntaub ntawv ncaj ncees yog ib feem ntawm cov txheej txheem zoo, tsis yog IT ntxiv -rau
ALCOA +
HyQure siv ALCOA + cov ntsiab lus kev ncaj ncees los txhawb cov khoom tsim nyog, tsim nyog, tsim nyog, niaj hnub, thawj, raug, ua tiav, zoo ib yam, ruaj khov, thiab muaj cov ntaub ntawv muaj.
LIMS/EMS/ES
HyQure siv cov tshuab hluav taws xob uas siv tau thiab kos npe hauv hluav taws xob los txhawb kev ua tiav, traceable, thiab cov txheej txheem ua lag luam hauv chav kuaj tau zoo.
- Validated, advanced electronic system
- Electronic Signature Management ua raws li Tshooj 11 thiab Annex 11 cov cai
- Cov txheej txheem ua lag luam tau zoo thiab ua tiav cov ntaub ntawv
- Tiag -lub sij hawm ib puag ncig parameter logging
- Audit txoj kev.
Computerized system validation
HyQure tswj xyuas lub tshuab computer kom siv tau nrog cov ntaub ntawv txog lub neej thiab kev pheej hmoo -raws li kev txheeb xyuas raws li kev npaj siv thiab GxP cov ntaub ntawv xav tau.
- System categorization assessment / GAMP system classification
- Tus neeg siv yuav tsum tau Specification (URS)
- Functional Specification (FS) thiab Design Specification (DS)
- Kev Ntsuam Xyuas Kev Risk (RA)
- IQ/OQ/PQ
- Validation Summary Report (VSR)
- Standard Operating Procedures (SOPs).
Cov ntaub ntawv zoo
HyQure siv cov ntaub ntawv tswj kom zoo los ntawm kev soj ntsuam hauv chav kuaj mus rau QA tshuaj xyuas kom cov ntaub ntawv khaws cia kom raug, tswj tau, thiab tshuaj xyuas- npaj txhij.
- Account thiab tswj kev nkag
- Thib ob -tus neeg tshuaj xyuas hauv chav kuaj
- Audit txoj kev
- QA tshuaj xyuas
- Tswj kev faib tawm thiab tau txais cov ntaub ntawv.
Data Security
HyQure tiv thaiv cov ntaub ntawv hluav taws xob thiab cov ntaub ntawv khaws tseg nrog kev tshem tawm -kev tiv thaiv, thaub qab, rov qab, thiab kho dua tshiab- kev sim tswj.
- Kev tiv thaiv kev tshem tawm (software-raws li)
- Lub sijhawm thaub qab zoo
- Backup execution log
- Kev npaj kho mob puas tsuaj
- Backup restoration test.
Cov ntaub ntawv lifecycle
Kev ntes; tshuaj xyuas; kev pom zoo; khaws cia; khaws cia; khaws cia; thaub qab.
Tus neeg siv khoom tus nqi
Tsawg dua cov ntaub ntawv uas tsis tuaj yeem zam tau- cov lus nug txog kev ncaj ncees, kev soj ntsuam kom pom tseeb dua, kev taug qab zoo dua, thiab kev tswj hwm muaj zog dua - ntsib kev ntseeg siab.
Kev sib tw cov neeg siv khoom lub kaum ntse ntse
Rau cov neeg siv khoom thoob ntiaj teb, tus nqi tsis yog cov cuab yeej digital xwb. Tus nqi yog traceable testing data, controlled reports, audit-trail discipline, validated computerized systems, and fast supplier-kev ntseeg siab.
Cov kev pabcuam HyQure ntsig txog
Npaj ib qho kev ua tau zoo - tau tsav pob kuaj
Qhia cov khoom lag luam, theem kev loj hlob, lub hom phiaj kev lag luam, hom qauv, txheej txheem txheej txheem, thiab xav tau daim ntawv tshaj tawm. HyQure tuaj yeem pab txhim kho cov peev txheej, cov ntaub ntawv, thiab ncua sij hawm ua ntej pib qhov project.
Txoj cai tswjfwm kev sib txuas
- FDA 21 CFR Part 11
- EU GMP Annex 11
- MHRA GxP Data Integrity Guide