{"id":2283,"date":"2021-12-22T12:18:12","date_gmt":"2021-12-22T11:18:12","guid":{"rendered":"https:\/\/www.akselera.com\/?p=2283"},"modified":"2026-03-10T12:16:48","modified_gmt":"2026-03-10T11:16:48","slug":"implementering-av-elektronisk-batch-protokoll-for-et-nytt-produksjonsomrade","status":"publish","type":"post","link":"https:\/\/www.akselera.com\/no\/implementering-av-elektronisk-batch-protokoll-for-et-nytt-produksjonsomrade\/","title":{"rendered":"Digitalisering av farmas\u00f8ytisk produksjon med elektroniske batch-registre (EBR)"},"content":{"rendered":"[vc_row type=&raquo;full_width_background&raquo; full_screen_row_position=&raquo;middle&raquo; column_margin=&raquo;default&raquo; column_direction=&raquo;default&raquo; column_direction_tablet=&raquo;default&raquo; column_direction_phone=&raquo;default&raquo; bg_image=&raquo;4579&#8243; bg_position=&raquo;center center&raquo; background_image_loading=&raquo;default&raquo; bg_repeat=&raquo;no-repeat&raquo; scene_position=&raquo;center&raquo; 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custom_height=&raquo;60&#8243;][nectar_single_testimonial testimonial_style=&raquo;bold&raquo; text_color=&raquo;#2C4E68&#8243; color=&raquo;Extra-Color-2&#8243; quote=&raquo;Til n\u00e5 har vi produsert batchdokumentasjon p\u00e5 omtrent 150\u2013200 sider per dag i dette produksjonsomr\u00e5det, som vi n\u00e5 slipper \u00e5 opprette, skrive ut, fylle inn, kontrollere og rekontrollere. 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phone_text_alignment=&raquo;default&raquo; background_color_opacity=&raquo;1&#8243; background_hover_color_opacity=&raquo;1&#8243; background_image=&raquo;4585&#8243; background_image_position=&raquo;center center&raquo; background_image_stacking=&raquo;default&raquo; enable_bg_scale=&raquo;true&raquo; background_image_loading=&raquo;default&raquo; column_backdrop_filter=&raquo;none&raquo; column_shadow=&raquo;none&raquo; column_border_radius=&raquo;none&raquo; column_link_target=&raquo;_self&raquo; column_position=&raquo;default&raquo; el_class=&raquo;test&raquo; gradient_direction=&raquo;left_to_right&raquo; overlay_strength=&raquo;0.3&#8243; width=&raquo;1\/2&#8243; tablet_width_inherit=&raquo;default&raquo; animation_type=&raquo;default&raquo; bg_image_animation=&raquo;none&raquo; border_type=&raquo;simple&raquo; column_border_width=&raquo;none&raquo; column_border_style=&raquo;solid&raquo; column_padding_type=&raquo;default&raquo; gradient_type=&raquo;default&raquo;][\/vc_column][vc_column column_padding=&raquo;padding-4-percent&raquo; 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column_border_style=&raquo;solid&raquo; column_padding_type=&raquo;default&raquo; gradient_type=&raquo;default&raquo;][vc_row_inner column_margin=&raquo;default&raquo; column_direction=&raquo;default&raquo; column_direction_tablet=&raquo;default&raquo; column_direction_phone=&raquo;default&raquo; text_align=&raquo;left&raquo; row_position=&raquo;default&raquo; row_position_tablet=&raquo;inherit&raquo; row_position_phone=&raquo;inherit&raquo; overflow=&raquo;visible&raquo; pointer_events=&raquo;all&raquo;][vc_column_inner column_padding=&raquo;no-extra-padding&raquo; column_padding_tablet=&raquo;inherit&raquo; column_padding_phone=&raquo;inherit&raquo; column_padding_position=&raquo;all&raquo; column_element_direction_desktop=&raquo;default&raquo; column_element_spacing=&raquo;default&raquo; desktop_text_alignment=&raquo;default&raquo; tablet_text_alignment=&raquo;default&raquo; phone_text_alignment=&raquo;default&raquo; background_color_opacity=&raquo;1&#8243; background_hover_color_opacity=&raquo;1&#8243; column_backdrop_filter=&raquo;none&raquo; column_shadow=&raquo;none&raquo; column_border_radius=&raquo;none&raquo; column_link_target=&raquo;_self&raquo; overflow=&raquo;visible&raquo; gradient_direction=&raquo;left_to_right&raquo; overlay_strength=&raquo;0.3&#8243; width=&raquo;1\/1&#8243; tablet_width_inherit=&raquo;default&raquo; animation_type=&raquo;default&raquo; enable_animation=&raquo;true&raquo; animation=&raquo;fade-in-from-bottom&raquo; animation_easing=&raquo;default&raquo; bg_image_animation=&raquo;none&raquo; border_type=&raquo;simple&raquo; column_border_width=&raquo;none&raquo; column_border_style=&raquo;solid&raquo;][vc_column_text css=&raquo;&raquo; text_direction=&raquo;default&raquo;]\n<h3 data-start=\"705\" data-end=\"733\"><strong data-start=\"709\" data-end=\"731\">Om kunden<\/strong><\/h3>\n<p data-start=\"734\" data-end=\"1070\">Kunden er et av verdens st\u00f8rste farmas\u00f8ytiske selskaper. Det har hovedkontor i Japan og opererer i mer enn 70 land. Selskapet er anerkjent som en global leder med et sterkt forskningsfokus og en tydelig forpliktelse til \u00e5 utvikle innovative behandlinger innen onkologi, gastroenterologi, nevrovitenskap og sjeldne sykdommer.  <\/p>\n<p data-start=\"1072\" data-end=\"1377\">Med titusenvis av ansatte og \u00e5rlige inntekter p\u00e5 over 16 milliarder USD opprettholder organisasjonen h\u00f8ye standarder for kvalitet, pasientsikkerhet og operasjonell fortreffelighet. Produksjonsnettverket f\u00f8lger strenge globale prosedyrer for \u00e5 sikre etterlevelse og effektivitet i alle ledd av produksjonen. <\/p>\n<h3 data-start=\"1379\" data-end=\"1402\"><strong data-start=\"1383\" data-end=\"1400\">Prosjektomfang<\/strong><\/h3>\n<p data-start=\"1403\" data-end=\"1666\">Ved ett av selskapets europeiske produksjonsanlegg hadde <strong data-start=\"1457\" data-end=\"1470\">PI-ark<\/strong> og <strong data-start=\"1475\" data-end=\"1509\">elektroniske batchregistre (EBR)<\/strong> allerede blitt tatt i bruk i utvalgte omr\u00e5der. For \u00e5 lansere et nytt produkt \u00f8nsket produksjonsteamene \u00e5 utvide EBR-funksjonaliteten til et nytt produksjonsomr\u00e5de. <\/p>\n<p data-start=\"1668\" data-end=\"1962\">Prosjektets hovedm\u00e5l var \u00e5 designe og implementere en ny PI-ark- og EBR-l\u00f8sning som kombinerte to n\u00f8kkeltrinn \u2014 veiing av r\u00e5materialer og miksing av halvferdige produkter \u2014 i \u00e9n integrert prosess. Den nye l\u00f8sningen bygde p\u00e5 eksisterende PI-ark-komponenter for \u00e5 sikre gjenbruk og konsistens. <\/p>\n<p data-start=\"1964\" data-end=\"2179\">Dette initiativet var en del av en bredere <strong data-start=\"2002\" data-end=\"2029\">digitaliseringsstrategi <\/strong>for produksjonsvirksomheten. M\u00e5let var \u00e5 forbedre prosesskonsistens, redusere manuelt arbeid og \u00f8ke dataintegriteten p\u00e5 tvers av alle produksjonslinjer. <\/p>\n<h3 data-start=\"2181\" data-end=\"2232\"><strong data-start=\"2185\" data-end=\"2230\">Akseleras rolle og resultater<\/strong><\/h3>\n<p data-start=\"2233\" data-end=\"2551\">Akselera leverte <strong data-start=\"2251\" data-end=\"2276\">l\u00f8sningsarkitektur <\/strong>og <strong data-start=\"2281\" data-end=\"2304\">SAP PP-PI-ekspertise<\/strong> gjennom hele prosjektet. V\u00e5re konsulenter jobbet tett med TechWeaver samt kundens produksjons- og kvalitetsteam for \u00e5 implementere en komplett elektronisk prosess for veiing av r\u00e5materialer, miksing av halvferdige materialer og batchdokumentasjon. <\/p>\n<p data-start=\"2553\" data-end=\"2905\">Den nye <strong data-start=\"2561\" data-end=\"2577\">EBR-l\u00f8sningen<\/strong> \u00f8kte graden av automatisering og gjorde produksjonsdata umiddelbart tilgjengelig for kvalitetsgjennomgang. Systemet markerte ogs\u00e5 avvik direkte i PI-ark og inspeksjonspartier, for eksempel feil bruk av utstyr eller resultater utenfor tillatte grenser. Som f\u00f8lge av dette ble avvik oppdaget og l\u00f8st raskere, noe som forbedret b\u00e5de sporbarhet og datakvalitet.  <\/p>\n<p data-start=\"2907\" data-end=\"3253\">Prosjektet leverte m\u00e5lbare forbedringer. Ledetidene ble redusert fordi produksjon og kvalitetsgjennomgang kunne foreg\u00e5 parallelt. Samarbeidet mellom teamene ble bedre, og risikoen for \u00e5 miste papirdokumentasjon forsvant helt. I tillegg reduserte automatisert datavalidering manuelt inntastings- og kontrollarbeid, noe som sparte tid og minimerte menneskelige feil.   <\/p>\n<p data-start=\"3255\" data-end=\"3493\">Gjennom denne implementeringen bidro Akselera til at kunden styrket etterlevelsen, \u00f8kte effektiviteten og akselererte produksjonsprosessene. Prosjektet ble en viktig milep\u00e6l i selskapets <strong data-start=\"3452\" data-end=\"3492\">digitale transformasjon av produksjonen.<\/strong> <\/p>\n[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row type=&raquo;in_container&raquo; full_screen_row_position=&raquo;middle&raquo; column_margin=&raquo;default&raquo; column_direction=&raquo;default&raquo; column_direction_tablet=&raquo;default&raquo; column_direction_phone=&raquo;default&raquo; scene_position=&raquo;center&raquo; text_color=&raquo;dark&raquo; text_align=&raquo;left&raquo; row_border_radius=&raquo;none&raquo; row_border_radius_applies=&raquo;bg&raquo; overflow=&raquo;visible&raquo; overlay_strength=&raquo;0.3&#8243; gradient_direction=&raquo;left_to_right&raquo; shape_divider_position=&raquo;bottom&raquo; bg_image_animation=&raquo;none&raquo;][vc_column column_padding=&raquo;no-extra-padding&raquo; column_padding_tablet=&raquo;inherit&raquo; column_padding_phone=&raquo;inherit&raquo; column_padding_position=&raquo;all&raquo; column_element_direction_desktop=&raquo;default&raquo; column_element_spacing=&raquo;default&raquo; desktop_text_alignment=&raquo;default&raquo; tablet_text_alignment=&raquo;default&raquo; phone_text_alignment=&raquo;default&raquo; background_color_opacity=&raquo;1&#8243; background_hover_color_opacity=&raquo;1&#8243; column_backdrop_filter=&raquo;none&raquo; column_shadow=&raquo;none&raquo; column_border_radius=&raquo;none&raquo; column_link_target=&raquo;_self&raquo; column_position=&raquo;default&raquo; gradient_direction=&raquo;left_to_right&raquo; overlay_strength=&raquo;0.3&#8243; width=&raquo;1\/1&#8243; tablet_width_inherit=&raquo;default&raquo; animation_type=&raquo;default&raquo; bg_image_animation=&raquo;none&raquo; border_type=&raquo;simple&raquo; column_border_width=&raquo;none&raquo; column_border_style=&raquo;solid&raquo;][divider line_type=&raquo;No Line&raquo;][\/vc_column][\/vc_row][vc_row type=&raquo;in_container&raquo; full_screen_row_position=&raquo;middle&raquo; column_margin=&raquo;default&raquo; column_direction=&raquo;default&raquo; column_direction_tablet=&raquo;default&raquo; column_direction_phone=&raquo;default&raquo; scene_position=&raquo;center&raquo; text_color=&raquo;dark&raquo; text_align=&raquo;left&raquo; row_border_radius=&raquo;none&raquo; row_border_radius_applies=&raquo;bg&raquo; overflow=&raquo;visible&raquo; overlay_strength=&raquo;0.3&#8243; gradient_direction=&raquo;left_to_right&raquo; shape_divider_position=&raquo;bottom&raquo; bg_image_animation=&raquo;none&raquo;][vc_column column_padding=&raquo;no-extra-padding&raquo; column_padding_tablet=&raquo;inherit&raquo; column_padding_phone=&raquo;inherit&raquo; column_padding_position=&raquo;all&raquo; column_element_direction_desktop=&raquo;default&raquo; column_element_spacing=&raquo;default&raquo; desktop_text_alignment=&raquo;default&raquo; tablet_text_alignment=&raquo;default&raquo; phone_text_alignment=&raquo;default&raquo; 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