Ukuqinisekiswa Kwendlela kungena esikhundleni samaspredishithi e-Excel okuqinisekiswa kwendlela yokuhlaziya ngohlelo lokusebenza olungaxhunyiwe ku-inthanethi kumafoni namathebulethi. Ufaka idatha eluhlaza kuphela kusuka kusiliphu sokukala kanye nemishini; uhlelo lokusebenza lubala ngokuzenzakalelayo wonke amapharamitha, luqhathanisa izindlela zokwamukela, bese luphetha nge-PASS / FAIL / INCOMPLETE DATA.
IZINQUBO EZINTATHU ZOKUQINISEKISA
• I-HPLC / GC ngokusho kwe-ICH Q2(R2): ukufaneleka kwesistimu (indawo ye-RSD, umsila, inani lamapuleti), ukulingana kanye nobubanzi bokusebenza (r, R², i-intercept, i-response coefficient, ama-residuals), ukuphindaphindeka, ukunemba ngokungeza amazinga ku-matrix yangempela yesampula enokuhlehla okujwayelekile kokwengeza, usuku lwesi-2 lokunemba okuphakathi (ukuhlolwa kwe-t, ukuhlolwa kwe-F, i-RSD ehlanganisiwe), isikhawu sokuzethemba esingu-95%, ukungaqiniseki kokulinganisa okuphezulu.
• Izinsimbi ezisindayo ngokusho kwe-Ph. Eur. 2.4.27 (GF-AAS, i-hydride, umhwamuko obandayo): ijika lokuqala/lokugcina lokulinganisa kanye nokukhukhuleka, i-reagent engenalutho (i-LOD/LOQ, i-N4 criterion), ukubuyisa amazinga amathathu angu-70–150% × izizinda ezintathu, isincomo segatsha le-f-factor kanye nendlela, i-LOQ ngokusho kwe-EP, ukuphindaphindeka Indlela A noma Indlela B, ukunemba okuphakathi kokuqhekeka kokuhlukahluka ngokusho kwe-ISO 5725, ukungaqiniseki kokulinganisa okuphezulu kuya phansi kanye nokubalwa okugcwele, ukufaneleka kwesistimu ngokufunda kabusha okujwayelekile, isiphetho samapharamitha angu-8 e-EP kanye nezindinganiso zangaphakathi ezi-5.
• Inqubo eyisisekelo ICH / USP <1225> / USP <1226> / ASEAN / ISO 17025: ukulungiswa kwekhompyutha (isixazululo sesitoko ngokuya ngobumsulwa, ukuncishiswa kwe-C1V1=C2V2, uhlelo lokwengeza olujwayelekile), ukuhlolwa okujwayelekile kwangaphandle okulula nokuthuthukisiwe, i-SST, ukunemba, ukuphindaphindeka, ukulingana ne-LOD/LOQ.
NGOKUFANELE NGOKUFANELE INOMBOLO
Wonke amafomula ahambisana nespredishithi yokuqala yelabhorethri kusetshenziswa amakhulu ezivivinyo ezenzakalelayo ngephutha lika-1e-9; izibalo ezijwayelekile: isampula yokuphambuka okujwayelekile, ukuhlehla okuqondile, i-TINV/FINV, i-ISO 5725, ama-Grubbs.
KULULA UKUSEBENZISA EDESKINI
• Okokufaka kwesinyathelo ngesinyathelo nge-progress loop, i-conclusion chip ngqo kumojula ngayinye, okokufaka okusheshayo kwekholomu (Enter ukuze uye emgqeni olandelayo) bese unamathisela kusuka ebhodini lokunamathisela.
• Thinta iseli yomphumela ukuze ubuke ifomula kanye nezinombolo ezifakiwe.
• Ideshibhodi ye-KPI, isifinyezo sesiphetho, imodi emnyama, isikhombimsebenzisi samakholomu amabili kumathebulethi.
• Hlehlisa/phinda wenze, shintsha ilogi yeseli ngayinye, isimo sefayela (uhlaka → luhloliwe → luvunyiwe, ukufakwa kwedatha kukhiyiwe), igama le-KNV kanye nesihloli.
• Thumela imibiko ye-PDF yaseVietnam, i-CSV, iphrojekthi yokusekela/yokubuyisela usebenzisa amafayela.
• Akukho akhawunti noma i-inthanethi edingekayo ukuze kubalwe; idatha igcinwa kudivayisi yakho.
KWA
Abahloli, iminyango ye-QC/QA, izikhungo zokuhlola zemithi/zokwelapha/zokudla, abafundisi kanye nabafundi besayensi yokuhlaziya.
Uhlelo lokusebenza lubonisa izikhangiso ukusekela intuthuko yalo; ungakhubaza unomphela zonke izikhangiso ngokuthenga kanye kuphela ngaphakathi kohlelo lokusebenza. Uhlelo lokusebenza luyithuluzi lokusekela ukubala futhi aluthathi indawo yeziphetho zokuhlola ezisemthethweni zelebhu yokuhlola.
Ukubalwa kokuqinisekiswa kwendlela yokuhlaziya: HPLC ICH Q2(R2), AAS Ph. Eur. 2.4.27
Kubuyekezwe ngo-
Okt 1, 2026