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EasyMatch QC ER: Software voor kleurmeting die voldoet aan de voorschriften

Kleurmeting volgens FDA 21 CFR Part 11 voor GxP gereguleerde bedrijvenDe validatie van processen binnen de kwaliteitsborging in de farmaceutische industrie is een essentieel onderdeel van Good Manufacturing Practice (GMP). HunterLab helpt klanten hun HunterLab apparaten en apparatuur te valideren om te voldoen aan de wettelijke vereisten. Geautomatiseerde softwareoplossingen, gedrukte handleidingen voor validatie en naleving, op maat gemaakte prestatiekwalificaties en on-site installatie en training zorgen voor naleving van de regelgeving.

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Uw voordelen in een oogopslag

ER-software voor laboratorium & productie

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Gevalideerde gebruikerslogin voor elke bevoegde gebruiker

[/difl_iconlistitem][difl_iconlistitem list_item_title=”E-handtekeningen” list_item_icon_type=”image” list_item_image=”https://staging2.hunterlab.de/wp-content/uploads/2024/04/check.png” list_item_image_width=”65px” list_item_image_height=”65px” list_item_icon_padding=”0px|0px|0px|0px|true|true” list_item_icon_placement_tablet=”” list_item_icon_placement_phone=”column” list_item_icon_placement_last_edited=”on|phone” _builder_version=”4.24.3″ global_colors_info=”{}”]

Ondertekenaar moet elke keer inloggen.

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Verwijderen van gegevens of manipulatie niet mogelijk.

[/difl_iconlistitem][/difl_iconlist]

[difl_imagecarousel item_desktop=”1″ item_tablet=”1″ centered_slides=”on” item_height_tablet=”” item_height_phone=”” item_height_last_edited=”on|phone” item_spacing_tablet=”250px” item_spacing_last_edited=”off|phone” ic_max_width_last_edited=”off|desktop” _builder_version=”4.24.3″ _module_preset=”default” custom_margin_tablet=”||||false|false” custom_margin_last_edited=”off|tablet” custom_padding=”||||true” custom_padding_tablet=”30px||30px||true|false” custom_padding_phone=”30px||30px||true|false” custom_padding_last_edited=”on|tablet” global_colors_info=”{}”][difl_imagecarouselitem image=”https://staging2.hunterlab.de/wp-content/uploads/2024/04/HunterLab-Colour-Measurement-GMP-1920w.png” alt_text=”EasyMatch QC” ic_button_button_url_new_window=”1″ _builder_version=”4.24.3″ _module_preset=”default” global_colors_info=”{}”][/difl_imagecarouselitem][/difl_imagecarousel]

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Controlespoor en gebeurtenissenlogboek maken een volledig beveiligd systeem mogelijk

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Gedrukt notitieboek voor documentatie van IQ-, OQ- en PQ-protocollen

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Installatie en training mogelijk op locatie of via online hulp.

[/difl_iconlistitem][/difl_iconlist]

Whitepaper-kleurmeting-door-21-CFR-Part-11

[difl_advanced_blurb title=”Whitepaper %22Kleurmeting volgens 21 CFR Deel 11%22″ sub_title=”Lees meer…” content_area_alignment=”left” order_enable=”on” sub_title_order=”6″ content_width=”480px” title_margin=”10px||||false|false” content_margin=”10px||||false|false” content_area_alignment_tablet=”center” content_area_alignment_phone=”center” content_area_alignment_last_edited=”on|tablet” content_width_tablet=”100%” content_width_phone=”100%” content_width_last_edited=”on|desktop” title_margin_tablet=”10px||||false|false” title_margin_phone=”0px||||false|false” title_margin_last_edited=”on|phone” sub_title_padding_tablet=”” sub_title_padding_phone=”||0px||false|false” sub_title_padding_last_edited=”on|phone” content_margin_tablet=”10px||||false|false” content_margin_phone=”0px||||false|false” content_margin_last_edited=”on|phone” _builder_version=”4.24.3″ _module_preset=”default” title_level=”h2″ title_font=”|700|||||||” title_text_color=”#FFFFFF” title_font_size=”42px” title_line_height=”46px” sub_title_font=”|600|||||||” sub_title_text_color=”#FFFFFF” sub_title_font_size=”22px” content_body_font=”||||||||” content_body_text_color=”#FFFFFF” content_body_font_size=”20px” content_body_line_height=”24px” max_width=”90%” max_width_tablet=”90%” max_width_phone=”100%” max_width_last_edited=”on|phone” module_alignment=”center” custom_padding_tablet=”20px||0px||false|false” custom_padding_phone=”20px||0px||false|false” custom_padding_last_edited=”on|tablet” title_font_size_tablet=”38px” title_font_size_phone=”32px” title_font_size_last_edited=”on|phone” title_line_height_tablet=”46px” title_line_height_phone=”42px” title_line_height_last_edited=”on|phone” content_body_text_align_tablet=”center” content_body_text_align_phone=”center” content_body_text_align_last_edited=”on|tablet” locked=”off” global_colors_info=”{}”]

Lees meer over het elektronisch bijhouden van gegevens en het maken van een digitaal kwalificatiedossier in onze nieuwe whitepaper.

[/difl_advanced_blurb]

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[difl_advanced_blurb title=”Veilig beheer van kleurgegevens” content_area_alignment=”center” order_enable=”on” sub_title_order=”6″ content_width=”100%” title_margin=”||||false|false” content_margin=”10px||||false|false” content_area_alignment_tablet=”center” content_area_alignment_phone=”center” content_area_alignment_last_edited=”on|tablet” title_margin_tablet=”10px||||false|false” title_margin_phone=”0px||||false|false” title_margin_last_edited=”off|desktop” title_padding_tablet=”” title_padding_phone=”||0px||false|false” title_padding_last_edited=”on|phone” sub_title_padding_tablet=”” sub_title_padding_phone=”” sub_title_padding_last_edited=”on|phone” _builder_version=”4.24.3″ _module_preset=”default” title_level=”h2″ title_font=”|700|||||||” title_text_align=”center” title_text_color=”#FFFFFF” title_font_size=”56px” title_line_height=”68px” sub_title_font=”|600|||||||” sub_title_text_color=”#073466″ content_body_font=”||||||||” content_body_text_color=”#FFFFFF” content_body_font_size=”16px” content_body_line_height=”24px” module_alignment=”left” custom_margin=”||||false|false” custom_padding=”||||false|false” title_font_size_tablet=”” title_font_size_phone=”28px” title_font_size_last_edited=”on|phone” title_line_height_tablet=”” title_line_height_phone=”42px” title_line_height_last_edited=”on|phone” sub_title_font_size_tablet=”” sub_title_font_size_phone=”18px” sub_title_font_size_last_edited=”on|phone” sub_title_line_height_tablet=”” sub_title_line_height_phone=”26px” sub_title_line_height_last_edited=”on|phone” content_body_text_align_tablet=”center” content_body_text_align_last_edited=”off|tablet” locked=”off” global_colors_info=”{}”]

HunterLabs EasyMatch QC software bevat in de ER (Electronic Recordkeeping) versie alle belangrijke aanvullingen om te voldoen aan de FDA (Food Drug Administration) regelgeving volgens 21 CFR Part 11. EasyMatch QC-ER bevat een Validation and Compliance Notebook met IQ- en OQ-protocollen en PQ-sjablonen. De software beschermt en onderhoudt volledige en nauwkeurige records, verifieert en beperkt de toegang tot het systeem, biedt een door de computer gegenereerd controlespoor en bevat een elektronische handtekening om manipulatiebestendige documentatie mogelijk te maken.

[/difl_advanced_blurb]

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SECTIE 1: 21 CFR DEEL 11 NALEVING

Wat is CFR 21 Deel 11
Hoe HunterLab een bedrijf helpt compliant te werken
Predicaatregels
Definities systeeminstellingen Windows

DEEL 2: IQ/OQ/PQ PROTOCOLLEN

Systeemoverzicht
Overzicht van de kwalificatieprotocollen
IQ-protocollen (installatiekwalificatie) voor hardware en software
OQ-protocollen (operationele kwalificatie)
PQ-protocollen (prestatiekwalificatie)

[/difl_advanced_blurb]

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21 CFR Part 11 regelt de technische en organisatorische vereisten waaraan moet worden voldaan om elektronische gegevens en documenten in plaats van papier te gebruiken bij de ontwikkeling, goedkeuring en productie. Sindsdien zijn alle sectoren van de farmaceutische industrie en de industrie voor medische hulpmiddelen die werken in gebieden die door de FDA worden gereguleerd – met name GLP (Good Laboratory Practice), GCP (Good Clinical Practice) en GMP (Good Manufacturing Practice) – verplicht om hun elektronische gegevens en computersystemen in overeenstemming te houden met 21 CFR Part 11. 21 CFR Part 11 is ook van toepassing op alle niet-Amerikaanse bedrijven die producten maken voor de Amerikaanse markt of die producten ontwikkelen met het oog op goedkeuring voor de Amerikaanse markt.

[/difl_advanced_blurb]

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Da Vincilaan 11 b
6716 WC
Ede Netherlands

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HunterLab Europa GmbH

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82418 Murnau

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Laboratorium Hunter Associates, Inc.

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6716 WC Ede
Netherlands

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HunterLab Azië Limited

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28 Wang Wo Tsai Street, Tsuen Wan, Nieuwe Gebieden, Hongkong

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[difl_advanced_blurb title=”Stel ons hier uw vraag…” content_area_alignment=”center” order_enable=”on” sub_title_order=”6″ content_width=”100%” title_margin=”||||false|false” content_margin=”10px||||false|false” admin_label=”Advanced Blurb” _builder_version=”4.27.4″ _module_preset=”default” title_font=”|700|||||||” title_text_align=”left” title_text_color=”#222222″ title_line_height=”29px” sub_title_font=”Nunito Sans|600|||||||” sub_title_text_color=”#e11d07″ content_body_font=”||||||||” content_body_text_align=”left” content_body_text_color=”RGBA(28,28,28,0.8)” content_body_font_size=”16px” content_body_line_height=”24px” max_width=”640px” module_alignment=”left” custom_margin=”0px||40px||false|false” global_module=”349643″ saved_tabs=”all” locked=”off” global_colors_info=”{}”]

Wilt u direct praten over uw aanvraag/staal? Bel ons op

+49 8841 9464

We tonen je de oplossing voor kleurmeting voor jouw product.

Of vul gewoon het onderstaande formulier in.

Onze colorimetrie-experts helpen je graag!

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Wil je je verder verdiepen in colorimetrie? Boek dan een van onze colorimetriecursussen, online of in-house. We bieden ook metingen op maat, huur- en leaseopties en tal van speciale ontwikkelingen. Overtuig jezelf van onze nauwkeurige spectrofotometers en competente service.

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