{"id":18264,"date":"2020-01-07T14:41:41","date_gmt":"2020-01-07T13:41:41","guid":{"rendered":"https:\/\/www.blackbirdee.fr\/prod\/ALISPHARM\/?page_id=18264"},"modified":"2022-02-14T14:26:05","modified_gmt":"2022-02-14T13:26:05","slug":"prestations","status":"publish","type":"page","link":"https:\/\/www.blackbirdee.fr\/prod\/ALISPHARM\/prestations\/","title":{"rendered":"Nos Prestations"},"content":{"rendered":"

[vc_row heading_color=\u00a0\u00bblight\u00a0\u00bb section_type=\u00a0\u00bbfullwidth\u00a0\u00bb bg_type=\u00a0\u00bbimage\u00a0\u00bb bg_image=\u00a0\u00bb19329″ bg_image_type=\u00a0\u00bbhorizontal-parallax-lr\u00a0\u00bb bg_image_size=\u00a0\u00bbfull\u00a0\u00bb parallax_threshold=\u00a0\u00bb0.1″ padding_top_multiplier=\u00a0\u00bbcustom\u00a0\u00bb padding_bottom_multiplier=\u00a0\u00bbcustom\u00a0\u00bb columns_gap=\u00a0\u00bbnone\u00a0\u00bb mobile_visibility=\u00a0\u00bbhide\u00a0\u00bb separator_bottom=\u00a0\u00bbtriangle-separator\u00a0\u00bb separator_bottom_size=\u00a0\u00bb60px\u00a0\u00bb font_color=\u00a0\u00bb#ffffff\u00a0\u00bb padding_top=\u00a0\u00bb210px\u00a0\u00bb padding_bottom=\u00a0\u00bb210px\u00a0\u00bb][vc_column width=\u00a0\u00bb2\/3″ css=\u00a0\u00bb.vc_custom_1574962950058{margin-left: 15% !important;}\u00a0\u00bb]

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NOS PRESTATIONS<\/span><\/h1>

Pour chaque prestation :<\/span>
\nDes intervenants op\u00e9rationnels et une \u00e9quipe d\u2019experts d\u00e9di\u00e9e au projet.<\/span><\/span><\/h2>
<\/div>[vc_row_inner][vc_column_inner width=\u00a0\u00bb1\/2″ el_class=\u00a0\u00bbcol1BtnHeaderPrestations\u00a0\u00bb]
Pharmaceutique & Biotechs<\/span><\/a><\/div>
<\/div>[\/vc_column_inner][vc_column_inner width=\u00a0\u00bb1\/2″]
Dispositifs m\u00e9dicaux<\/span><\/a><\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=\u00a0\u00bb1\/3″][\/vc_column][\/vc_row][vc_row heading_color=\u00a0\u00bblight\u00a0\u00bb section_type=\u00a0\u00bbfullwidth\u00a0\u00bb bg_type=\u00a0\u00bbimage\u00a0\u00bb bg_image=\u00a0\u00bb19330″ bg_image_type=\u00a0\u00bbhorizontal-parallax-lr\u00a0\u00bb bg_image_size=\u00a0\u00bbfull\u00a0\u00bb padding_top_multiplier=\u00a0\u00bb2x\u00a0\u00bb padding_bottom_multiplier=\u00a0\u00bb6x\u00a0\u00bb columns_gap=\u00a0\u00bbnone\u00a0\u00bb desktop_visibility=\u00a0\u00bbhide\u00a0\u00bb tablet_visibility=\u00a0\u00bbhide\u00a0\u00bb tablet_sm_visibility=\u00a0\u00bbhide\u00a0\u00bb separator_bottom=\u00a0\u00bbtriangle-separator\u00a0\u00bb separator_bottom_size=\u00a0\u00bb60px\u00a0\u00bb font_color=\u00a0\u00bb#ffffff\u00a0\u00bb][vc_column width=\u00a0\u00bb1\/6″][\/vc_column][vc_column width=\u00a0\u00bb1\/2″ css=\u00a0\u00bb.vc_custom_1574759425560{padding-right: 5% !important;padding-left: 8% !important;}\u00a0\u00bb]
NOS PRESTATIONS<\/span><\/span><\/div>
Pour chaque prestation :<\/span>
\nDes intervenants op\u00e9rationnels et une \u00e9quipe d\u2019experts d\u00e9di\u00e9e au projet.<\/span><\/span><\/div>
<\/div>[vc_row_inner][vc_column_inner width=\u00a0\u00bb1\/2″ el_class=\u00a0\u00bbcol1BtnHeaderPrestations\u00a0\u00bb]
Pharmaceutique & Biotechs<\/span><\/a><\/div>
<\/div>[\/vc_column_inner][vc_column_inner width=\u00a0\u00bb1\/2″]
Dispositifs m\u00e9dicaux<\/span><\/a><\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=\u00a0\u00bb1\/3″][\/vc_column][\/vc_row][vc_row section_type=\u00a0\u00bbfullwidth\u00a0\u00bb bg_type=\u00a0\u00bbcolor\u00a0\u00bb padding_top_multiplier=\u00a0\u00bb\u00a0\u00bb padding_bottom_multiplier=\u00a0\u00bb\u00a0\u00bb columns_gap=\u00a0\u00bbnone\u00a0\u00bb equal_column_height=\u00a0\u00bbequal-column\u00a0\u00bb mobile_visibility=\u00a0\u00bbhide\u00a0\u00bb bg_color=\u00a0\u00bb#ffffff\u00a0\u00bb section_id=\u00a0\u00bbpharma1″][vc_column vertical_content_position=\u00a0\u00bbmiddle\u00a0\u00bb css=\u00a0\u00bb.vc_custom_1574693840583{margin-right: 5% !important;margin-left: 9% !important;}\u00a0\u00bb]
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PHARMACEUTIQUE & BIOTECHS<\/span><\/h3>
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<\/div>

PHARMACEUTIQUE & BIOTECHS<\/span><\/h3>
<\/div>[\/vc_column][\/vc_row][vc_row section_type=\u00a0\u00bbfullwidth\u00a0\u00bb bg_type=\u00a0\u00bbcolor\u00a0\u00bb padding_top_multiplier=\u00a0\u00bb\u00a0\u00bb padding_bottom_multiplier=\u00a0\u00bb\u00a0\u00bb columns_gap=\u00a0\u00bbnone\u00a0\u00bb equal_column_height=\u00a0\u00bbequal-column\u00a0\u00bb tablet_sm_visibility=\u00a0\u00bbhide\u00a0\u00bb mobile_visibility=\u00a0\u00bbhide\u00a0\u00bb bg_color=\u00a0\u00bb#ffffff\u00a0\u00bb][vc_column vertical_content_position=\u00a0\u00bbmiddle\u00a0\u00bb width=\u00a0\u00bb1\/2″][vc_single_image image=\u00a0\u00bb19336″ img_size=\u00a0\u00bb\u00a0\u00bb][\/vc_column][vc_column vertical_content_position=\u00a0\u00bbmiddle\u00a0\u00bb width=\u00a0\u00bb1\/2″ css=\u00a0\u00bb.vc_custom_1574689001450{padding-right: 8% !important;padding-left: 12% !important;}\u00a0\u00bb]

AlisPharm<\/span> accompagne les industries pharmaceutiques et des biotechnologies dans le d\u00e9veloppement de leurs produits et leurs process, avec une expertise qualit\u00e9 et r\u00e9glementaire solide pour faire \u00abBon du premier coup\u00bb<\/span>.<\/span><\/span><\/h4>
<\/div>[\/vc_column][\/vc_row][vc_row section_type=\u00a0\u00bbfullwidth\u00a0\u00bb bg_type=\u00a0\u00bbcolor\u00a0\u00bb padding_top_multiplier=\u00a0\u00bb\u00a0\u00bb padding_bottom_multiplier=\u00a0\u00bb3x\u00a0\u00bb columns_gap=\u00a0\u00bbnone\u00a0\u00bb equal_column_height=\u00a0\u00bbequal-column\u00a0\u00bb desktop_visibility=\u00a0\u00bbhide\u00a0\u00bb tablet_visibility=\u00a0\u00bbhide\u00a0\u00bb mobile_visibility=\u00a0\u00bbhide\u00a0\u00bb bg_color=\u00a0\u00bb#ffffff\u00a0\u00bb][vc_column vertical_content_position=\u00a0\u00bbmiddle\u00a0\u00bb width=\u00a0\u00bb1\/2″][vc_single_image image=\u00a0\u00bb19336″ img_size=\u00a0\u00bb\u00a0\u00bb][\/vc_column][vc_column width=\u00a0\u00bb1\/2″ css=\u00a0\u00bb.vc_custom_1574689811188{padding-right: 8% !important;padding-left: 12% !important;}\u00a0\u00bb]

AlisPharm<\/span> accompagne les industries pharmaceutiques et des biotechnologies dans le d\u00e9veloppement de leurs produits et leurs process, avec une expertise qualit\u00e9 et r\u00e9glementaire solide pour faire \u00abBon du premier coup\u00bb<\/span>.<\/span><\/span><\/h4>[\/vc_column][\/vc_row][vc_row section_type=\u00a0\u00bbfullwidth\u00a0\u00bb bg_type=\u00a0\u00bbcolor\u00a0\u00bb padding_top_multiplier=\u00a0\u00bb\u00a0\u00bb padding_bottom_multiplier=\u00a0\u00bb\u00a0\u00bb columns_gap=\u00a0\u00bbnone\u00a0\u00bb desktop_visibility=\u00a0\u00bbhide\u00a0\u00bb tablet_visibility=\u00a0\u00bbhide\u00a0\u00bb tablet_sm_visibility=\u00a0\u00bbhide\u00a0\u00bb bg_color=\u00a0\u00bb#ffffff\u00a0\u00bb][vc_column width=\u00a0\u00bb1\/2″ css=\u00a0\u00bb.vc_custom_1574682461478{padding-right: 8% !important;padding-left: 8% !important;}\u00a0\u00bb]

AlisPharm<\/span> accompagne les industries pharmaceutiques et des biotechnologies dans le d\u00e9veloppement de leurs produits et leurs process, avec une expertise qualit\u00e9 et r\u00e9glementaire solide pour faire \u00abBon du premier coup\u00bb<\/span>.<\/span><\/span><\/h4>
<\/div>[\/vc_column][vc_column width=\u00a0\u00bb1\/2″][vc_single_image image=\u00a0\u00bb19336″ img_size=\u00a0\u00bb\u00a0\u00bb][\/vc_column][\/vc_row][vc_row section_type=\u00a0\u00bbfullwidth\u00a0\u00bb bg_type=\u00a0\u00bbcolor\u00a0\u00bb padding_top_multiplier=\u00a0\u00bb\u00a0\u00bb padding_bottom_multiplier=\u00a0\u00bb\u00a0\u00bb columns_gap=\u00a0\u00bbnone\u00a0\u00bb equal_column_height=\u00a0\u00bbequal-column\u00a0\u00bb bg_color=\u00a0\u00bb#ffffff\u00a0\u00bb][vc_column vertical_content_position=\u00a0\u00bbmiddle\u00a0\u00bb column_custom_position=\u00a0\u00bbyes\u00a0\u00bb position_top=\u00a0\u00bbminus-6x\u00a0\u00bb width=\u00a0\u00bb1\/3″][\/vc_column][vc_column column_effect=\u00a0\u00bbvertical-parallax\u00a0\u00bb column_effect_limit=\u00a0\u00bb5x\u00a0\u00bb column_effect_invert=\u00a0\u00bbtrue\u00a0\u00bb column_custom_position=\u00a0\u00bbyes\u00a0\u00bb position_top=\u00a0\u00bbminus-6x\u00a0\u00bb width=\u00a0\u00bb1\/5″ tablet_sm_width=\u00a0\u00bbhide\u00a0\u00bb mobile_width=\u00a0\u00bbhide\u00a0\u00bb css=\u00a0\u00bb.vc_custom_1574430692011{padding-right: 10% !important;padding-left: 10% !important;background-color: #00bbff !important;}\u00a0\u00bb]
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<\/div>[\/vc_column][vc_column width=\u00a0\u00bb1\/3″][\/vc_column][\/vc_row][vc_row section_type=\u00a0\u00bbfullwidth\u00a0\u00bb bg_type=\u00a0\u00bbcolor\u00a0\u00bb padding_top_multiplier=\u00a0\u00bb\u00a0\u00bb padding_bottom_multiplier=\u00a0\u00bb\u00a0\u00bb columns_gap=\u00a0\u00bbnone\u00a0\u00bb tablet_sm_visibility=\u00a0\u00bbhide\u00a0\u00bb mobile_visibility=\u00a0\u00bbhide\u00a0\u00bb bg_color=\u00a0\u00bb#ffffff\u00a0\u00bb el_class=\u00a0\u00bbblocDynamiquePrestations1″][vc_column vertical_content_position=\u00a0\u00bbmiddle\u00a0\u00bb column_custom_position=\u00a0\u00bbyes\u00a0\u00bb position_top=\u00a0\u00bbminus-3x\u00a0\u00bb width=\u00a0\u00bb1\/2″ text_align=\u00a0\u00bbright\u00a0\u00bb el_wrapper_class=\u00a0\u00bbblocMenuPharmaPrestations\u00a0\u00bb][vc_row_inner][vc_column_inner width=\u00a0\u00bb1\/4″][\/vc_column_inner][vc_column_inner width=\u00a0\u00bb3\/4″]

01 <\/span>ASSURANCE QUALIT\u00c9 OP\u00c9RATIONNELLE<\/span>
\n02 <\/span>SYST\u00c8ME DE MANAGEMENT DE LA QUALIT\u00c9<\/span>
\n03 <\/span>TRANSFERT INDUSTRIEL
\n<\/span>04 <\/span>COMMISSIONING & ENGINEERING<\/span>
\n05 <\/span>VALIDATION DES SYST\u00c8MES INFORMATIS\u00c9S<\/span>
\n06 <\/span>VALIDATION DES SYST\u00c8MES AUTOMATIS\u00c9S<\/span>
\n07 <\/span>CONTR\u00d4LE QUALIT\u00c9<\/span>
\n08 <\/span>AFFAIRES R\u00c9GLEMENTAIRES<\/span>
\n09 <\/span>PHARMACOVIGILANCE & CLINIQUE<\/span>
\n10 <\/span>VALIDATION DE PROC\u00c9D\u00c9S
\n<\/span>11 <\/span>QUALIFICATION D\u2019\u00c9QUIPEMENTS<\/span><\/span><\/span><\/h4>
<\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column column_custom_position=\u00a0\u00bbyes\u00a0\u00bb position_top=\u00a0\u00bbminus-3x\u00a0\u00bb width=\u00a0\u00bb1\/2″ clipping_animation=\u00a0\u00bbclipping-up\u00a0\u00bb el_wrapper_class=\u00a0\u00bbblocRollPharmaPrestations\u00a0\u00bb][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574702793319{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 9% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma1″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]
<\/div>

ASSURANCE QUALIT\u00c9 OP\u00c9RATIONNELLE<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Traitement des \u00e9v\u00e8nements qualit\u00e9 \/ NC \/ CAPA \/ Change control<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Coordination des plans d\u2019actions qualit\u00e9<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Gestion de la qualit\u00e9 aupr\u00e8s des fournisseurs, production et laboratoire<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574702800973{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 9% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma2″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]
<\/div>

SYST\u00c8ME DE MANAGEMENT DE LA QUALIT\u00c9<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Cr\u00e9ation et r\u00e9vision du SMQ selon les BPF\/GMP<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Pr\u00e9paration des audits et gestion des r\u00e9ponses post audit<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Formation, sensibilisation, accompagnement du personnel dans la d\u00e9marche qualit\u00e9<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574702810108{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 9% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma3″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]
<\/div>

TRANSFERT INDUSTRIEL<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Gestion des transferts inter et intra site (lignes compl\u00e8tes ou d\u00e9m\u00e9nagement d\u2019\u00e9quipements)<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Scale up, scale down<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Transfert analytique, transfert technologique<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574702818685{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 9% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma4″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]
<\/div>

COMMISSIONING & ENGINEERING<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Besoins utilisateurs, r\u00e9daction des cahiers des charges, d\u00e9finition des sp\u00e9cifications<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Achat et installation d\u2019\u00e9quipements, syst\u00e8mes automatis\u00e9s, utilit\u00e9s, locaux<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Pilotage des fournisseurs, de l\u2019installation, des tests<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574892770723{padding-top: 7% !important;padding-right: 10% !important;padding-bottom: 7% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma5″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

VALIDATION DES SYST\u00c8MES INFORMATIS\u00c9S<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Validation des syst\u00e8mes informatis\u00e9s (environnement GAMP5, 21CFR part11)<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>ERP, GED, syst\u00e8mes automatis\u00e9s & embarqu\u00e9s<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Tests d\u2019int\u00e9gration, logiciels, unitaires, non-r\u00e9gression<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Projets Data Integrity (tra\u00e7abilit\u00e9, acc\u00e8s, audit trail)<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574702840629{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 9% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma6″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]
<\/div>

VALIDATION DES SYST\u00c8MES AUTOMATIS\u00c9S<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Syst\u00e8mes de productions et de laboratoires (PLC, IHM) et Supervision SCADA<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Audit trail, gestion des acc\u00e8s, sauvegarde, back-up, restore<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>VMP, protocoles, rapports<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574702849540{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 9% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma7″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]
<\/div>

CONTR\u00d4LE QUALIT\u00c9<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>D\u00e9veloppement et validation analytiques et microbiologiques<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Analyses des r\u00e9sultats d\u2019analyses, gestion des OOS<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Projet data integrity, installation LIMS<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574702859075{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 9% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma8″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]
<\/div>

AFFAIRES R\u00c9GLEMENTAIRES<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>R\u00e9daction des dossiers d\u2019AMM<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Modules 2, 3, 4 et 5 (format CTD et e-CTD)<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>R\u00e9ponses aux autorit\u00e9s de sant\u00e9 des diff\u00e9rents pays<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574702869643{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 9% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma9″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]
<\/div>

PHARMACOVIGILANCE & CLINIQUE<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Gestion des \u00e9v\u00e8nements ind\u00e9sirables, rapports d\u2019EI<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>R\u00e9daction des rapports de PV (PSURs)<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Gestion du b\u00e9n\u00e9fice\/risque des produits<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574959967016{padding-top: 5% !important;padding-right: 10% !important;padding-bottom: 5% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma10″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

VALIDATION DE PROC\u00c9D\u00c9S<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Optimisation des proc\u00e9d\u00e9s de fabrication et de nettoyage<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Plan d\u2019exp\u00e9rience, outils statistiques de ma\u00eetrise des proc\u00e9d\u00e9s<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Validation des proc\u00e9d\u00e9s de fabrication, nettoyage, st\u00e9rilisation, conditionnement<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>D\u00e9finition des strat\u00e9gies et des worst case (\u00e9quipement, produit)<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574702888227{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 9% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma11″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]
<\/div>

QUALIFICATION D\u2019\u00c9QUIPEMENTS<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Equipements de laboratoire, de production, utilit\u00e9s, locaux<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>FAT, SAT, QI, QO, QP<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>VMP, protocoles, rapports<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row section_type=\u00a0\u00bbfullwidth\u00a0\u00bb bg_type=\u00a0\u00bbcolor\u00a0\u00bb padding_top_multiplier=\u00a0\u00bb\u00a0\u00bb padding_bottom_multiplier=\u00a0\u00bb\u00a0\u00bb columns_gap=\u00a0\u00bbnone\u00a0\u00bb desktop_visibility=\u00a0\u00bbhide\u00a0\u00bb tablet_visibility=\u00a0\u00bbhide\u00a0\u00bb bg_color=\u00a0\u00bb#ffffff\u00a0\u00bb el_class=\u00a0\u00bbblocDynamiquePrestations1″][vc_column vertical_content_position=\u00a0\u00bbmiddle\u00a0\u00bb width=\u00a0\u00bb1\/2″ el_wrapper_class=\u00a0\u00bbblocMenuPharmaPrestations\u00a0\u00bb]

01 <\/span>ASSURANCE QUALIT\u00c9 OP\u00c9RATIONNELLE<\/span>
\n02 <\/span>SYST\u00c8ME DE MANAGEMENT DE LA QUALIT\u00c9<\/span>
\n03 <\/span>TRANSFERT INDUSTRIEL
\n<\/span>04 <\/span>COMMISSIONING & ENGINEERING<\/span>
\n05 <\/span>VALIDATION DES SYST\u00c8MES INFORMATIS\u00c9S<\/span>
\n06 <\/span>VALIDATION DES SYST\u00c8MES AUTOMATIS\u00c9S<\/span>
\n07 <\/span>CONTR\u00d4LE QUALIT\u00c9<\/span>
\n08 <\/span>AFFAIRES R\u00c9GLEMENTAIRES<\/span>
\n09 <\/span>PHARMACOVIGILANCE & CLINIQUE<\/span>
\n10 <\/span>VALIDATION DE PROC\u00c9D\u00c9S
\n<\/span>11 <\/span>QUALIFICATION D\u2019\u00c9QUIPEMENTS<\/span><\/span><\/span><\/h4>
<\/div>[\/vc_column][vc_column width=\u00a0\u00bb1\/2″ el_wrapper_class=\u00a0\u00bbblocRollPharmaPrestations\u00a0\u00bb][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960341286{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma1″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

ASSURANCE QUALIT\u00c9 OP\u00c9RATIONNELLE<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Traitement des \u00e9v\u00e8nements qualit\u00e9 \/ NC \/ CAPA \/ Change control<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Coordination des plans d\u2019actions qualit\u00e9<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Gestion de la qualit\u00e9 aupr\u00e8s des fournisseurs, production et laboratoire<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960335232{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma2″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

SYST\u00c8ME DE MANAGEMENT DE LA QUALIT\u00c9<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Cr\u00e9ation et r\u00e9vision du SMQ selon les BPF\/GMP<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Pr\u00e9paration des audits et gestion des r\u00e9ponses post audit<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Formation, sensibilisation, accompagnement du personnel dans la d\u00e9marche qualit\u00e9<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960329408{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma3″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

TRANSFERT INDUSTRIEL<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Gestion des transferts inter et intra site (lignes compl\u00e8tes ou d\u00e9m\u00e9nagement d\u2019\u00e9quipements)<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Scale up, scale down<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Transfert analytique, transfert technologique<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960322868{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma4″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

COMMISSIONING & ENGINEERING<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Besoins utilisateurs, r\u00e9daction des cahiers des charges, d\u00e9finition des sp\u00e9cifications<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Achat et installation d\u2019\u00e9quipements, syst\u00e8mes automatis\u00e9s, utilit\u00e9s, locaux<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Pilotage des fournisseurs, de l\u2019installation, des tests<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960314824{padding-top: 7% !important;padding-right: 10% !important;padding-bottom: 7% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma5″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

VALIDATION DES SYST\u00c8MES INFORMATIS\u00c9S<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Validation des syst\u00e8mes informatis\u00e9s (environnement GAMP5, 21CFR part11)<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>ERP, GED, syst\u00e8mes automatis\u00e9s & embarqu\u00e9s<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Tests d\u2019int\u00e9gration, logiciels, unitaires, non-r\u00e9gression<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Projets Data Integrity (tra\u00e7abilit\u00e9, acc\u00e8s, audit trail)<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960296575{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma6″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

VALIDATION DES SYST\u00c8MES AUTOMATIS\u00c9S<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Syst\u00e8mes de productions et de laboratoires (PLC, IHM) et Supervision SCADA<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Audit trail, gestion des acc\u00e8s, sauvegarde, back-up, restore<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>VMP, protocoles, rapports<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960289983{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma7″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

CONTR\u00d4LE QUALIT\u00c9<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>D\u00e9veloppement et validation analytiques et microbiologiques<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Analyses des r\u00e9sultats d\u2019analyses, gestion des OOS<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Projet data integrity, installation LIMS<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960283315{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma8″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

AFFAIRES R\u00c9GLEMENTAIRES<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>R\u00e9daction des dossiers d\u2019AMM<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Modules 2, 3, 4 et 5 (format CTD et e-CTD)<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>R\u00e9ponses aux autorit\u00e9s de sant\u00e9 des diff\u00e9rents pays<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960277475{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma9″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

PHARMACOVIGILANCE & CLINIQUE<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Gestion des \u00e9v\u00e8nements ind\u00e9sirables, rapports d\u2019EI<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>R\u00e9daction des rapports de PV (PSURs)<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Gestion du b\u00e9n\u00e9fice\/risque des produits<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960269979{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma10″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

VALIDATION DE PROC\u00c9D\u00c9S<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Optimisation des proc\u00e9d\u00e9s de fabrication et de nettoyage<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Plan d\u2019exp\u00e9rience, outils statistiques de ma\u00eetrise des proc\u00e9d\u00e9s<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Validation des proc\u00e9d\u00e9s de fabrication, nettoyage, st\u00e9rilisation, conditionnement<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>D\u00e9finition des strat\u00e9gies et des worst case (\u00e9quipement, produit)<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960263953{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsPharma11″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

QUALIFICATION D\u2019\u00c9QUIPEMENTS<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Equipements de laboratoire, de production, utilit\u00e9s, locaux<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>FAT, SAT, QI, QO, QP<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>VMP, protocoles, rapports<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row section_type=\u00a0\u00bbfullwidth\u00a0\u00bb bg_type=\u00a0\u00bbcolor\u00a0\u00bb padding_top_multiplier=\u00a0\u00bb\u00a0\u00bb padding_bottom_multiplier=\u00a0\u00bb\u00a0\u00bb columns_gap=\u00a0\u00bbnone\u00a0\u00bb equal_column_height=\u00a0\u00bbequal-column\u00a0\u00bb desktop_visibility=\u00a0\u00bbhide\u00a0\u00bb tablet_visibility=\u00a0\u00bbhide\u00a0\u00bb bg_color=\u00a0\u00bb#ffffff\u00a0\u00bb][vc_column vertical_content_position=\u00a0\u00bbmiddle\u00a0\u00bb css=\u00a0\u00bb.vc_custom_1574701962600{margin-right: 4% !important;margin-left: 5% !important;}\u00a0\u00bb]
<\/div>[\/vc_column][\/vc_row][vc_row section_type=\u00a0\u00bbfullwidth\u00a0\u00bb bg_type=\u00a0\u00bbcolor\u00a0\u00bb padding_top_multiplier=\u00a0\u00bb\u00a0\u00bb padding_bottom_multiplier=\u00a0\u00bb\u00a0\u00bb columns_gap=\u00a0\u00bbnone\u00a0\u00bb equal_column_height=\u00a0\u00bbequal-column\u00a0\u00bb mobile_visibility=\u00a0\u00bbhide\u00a0\u00bb bg_color=\u00a0\u00bb#ffffff\u00a0\u00bb section_id=\u00a0\u00bbdispositifs1″][vc_column vertical_content_position=\u00a0\u00bbmiddle\u00a0\u00bb css=\u00a0\u00bb.vc_custom_1574701962600{margin-right: 4% !important;margin-left: 5% !important;}\u00a0\u00bb]
<\/div>

DISPOSITIFS M\u00c9DICAUX<\/span><\/h3>
<\/div>[\/vc_column][\/vc_row][vc_row section_type=\u00a0\u00bbfullwidth\u00a0\u00bb bg_type=\u00a0\u00bbcolor\u00a0\u00bb padding_top_multiplier=\u00a0\u00bb\u00a0\u00bb padding_bottom_multiplier=\u00a0\u00bb\u00a0\u00bb columns_gap=\u00a0\u00bbnone\u00a0\u00bb equal_column_height=\u00a0\u00bbequal-column\u00a0\u00bb desktop_visibility=\u00a0\u00bbhide\u00a0\u00bb tablet_visibility=\u00a0\u00bbhide\u00a0\u00bb tablet_sm_visibility=\u00a0\u00bbhide\u00a0\u00bb bg_color=\u00a0\u00bb#ffffff\u00a0\u00bb section_id=\u00a0\u00bbdispositifs2″][vc_column vertical_content_position=\u00a0\u00bbmiddle\u00a0\u00bb css=\u00a0\u00bb.vc_custom_1574690555134{margin-right: 8% !important;margin-left: 8% !important;}\u00a0\u00bb]

DISPOSITIFS M\u00c9DICAUX<\/span><\/h3>
<\/div>[\/vc_column][\/vc_row][vc_row section_type=\u00a0\u00bbfullwidth\u00a0\u00bb bg_type=\u00a0\u00bbcolor\u00a0\u00bb padding_top_multiplier=\u00a0\u00bb\u00a0\u00bb padding_bottom_multiplier=\u00a0\u00bb\u00a0\u00bb columns_gap=\u00a0\u00bbnone\u00a0\u00bb equal_column_height=\u00a0\u00bbequal-column\u00a0\u00bb tablet_sm_visibility=\u00a0\u00bbhide\u00a0\u00bb mobile_visibility=\u00a0\u00bbhide\u00a0\u00bb bg_color=\u00a0\u00bb#ffffff\u00a0\u00bb][vc_column vertical_content_position=\u00a0\u00bbmiddle\u00a0\u00bb width=\u00a0\u00bb1\/2″ css=\u00a0\u00bb.vc_custom_1574689022532{padding-right: 12% !important;padding-left: 17% !important;}\u00a0\u00bb]

Dans un environnement r\u00e9glementaire en \u00e9volution constante, AlisPharm<\/span> guide le fabricant de dispositif m\u00e9dical, tout au long du cycle de vie de son produit, afin de r\u00e9pondre aux attentes des autorit\u00e9s de sant\u00e9 et de permettre une mise sur le march\u00e9 fiable.<\/span><\/span><\/span><\/h4>
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Dans un environnement r\u00e9glementaire en constante \u00e9volution, AlisPharm<\/span> guide le fabricant de dispositif m\u00e9dical, tout au long du cycle de vie de son produit, afin de r\u00e9pondre aux attentes des autorit\u00e9s de sant\u00e9 et de permettre une mise sur le march\u00e9 fiable.<\/span><\/span><\/span><\/h4>[\/vc_column][\/vc_row][vc_row section_type=\u00a0\u00bbfullwidth\u00a0\u00bb bg_type=\u00a0\u00bbcolor\u00a0\u00bb padding_top_multiplier=\u00a0\u00bb\u00a0\u00bb padding_bottom_multiplier=\u00a0\u00bb\u00a0\u00bb columns_gap=\u00a0\u00bbnone\u00a0\u00bb desktop_visibility=\u00a0\u00bbhide\u00a0\u00bb tablet_visibility=\u00a0\u00bbhide\u00a0\u00bb tablet_sm_visibility=\u00a0\u00bbhide\u00a0\u00bb bg_color=\u00a0\u00bb#ffffff\u00a0\u00bb][vc_column width=\u00a0\u00bb1\/2″ css=\u00a0\u00bb.vc_custom_1574682461478{padding-right: 8% !important;padding-left: 8% !important;}\u00a0\u00bb]

Dans un environnement r\u00e9glementaire en constante \u00e9volution, AlisPharm<\/span> guide le fabricant de dispositif m\u00e9dical, tout au long du cycle de vie de son produit, afin de r\u00e9pondre aux attentes des autorit\u00e9s de sant\u00e9 et de permettre une mise sur le march\u00e9 fiable.<\/span><\/span><\/span><\/h4>
<\/div>[\/vc_column][vc_column width=\u00a0\u00bb1\/2″][vc_single_image image=\u00a0\u00bb19337″ img_size=\u00a0\u00bb\u00a0\u00bb][\/vc_column][\/vc_row][vc_row section_type=\u00a0\u00bbfullwidth\u00a0\u00bb bg_type=\u00a0\u00bbcolor\u00a0\u00bb padding_top_multiplier=\u00a0\u00bb\u00a0\u00bb padding_bottom_multiplier=\u00a0\u00bb\u00a0\u00bb columns_gap=\u00a0\u00bbnone\u00a0\u00bb equal_column_height=\u00a0\u00bbequal-column\u00a0\u00bb bg_color=\u00a0\u00bb#ffffff\u00a0\u00bb][vc_column vertical_content_position=\u00a0\u00bbmiddle\u00a0\u00bb column_custom_position=\u00a0\u00bbyes\u00a0\u00bb position_top=\u00a0\u00bbminus-6x\u00a0\u00bb width=\u00a0\u00bb2\/5″][\/vc_column][vc_column column_effect=\u00a0\u00bbvertical-parallax\u00a0\u00bb column_effect_limit=\u00a0\u00bb5x\u00a0\u00bb column_effect_invert=\u00a0\u00bbtrue\u00a0\u00bb column_custom_position=\u00a0\u00bbyes\u00a0\u00bb position_top=\u00a0\u00bbminus-6x\u00a0\u00bb width=\u00a0\u00bb1\/3″ tablet_sm_width=\u00a0\u00bbhide\u00a0\u00bb mobile_width=\u00a0\u00bbhide\u00a0\u00bb css=\u00a0\u00bb.vc_custom_1575368627384{margin-right: 20% !important;margin-left: 20% !important;padding-right: 10% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb]
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<\/div>[\/vc_column][vc_column width=\u00a0\u00bb1\/5″][\/vc_column][\/vc_row][vc_row section_type=\u00a0\u00bbfullwidth\u00a0\u00bb bg_type=\u00a0\u00bbcolor\u00a0\u00bb padding_top_multiplier=\u00a0\u00bb\u00a0\u00bb padding_bottom_multiplier=\u00a0\u00bb\u00a0\u00bb columns_gap=\u00a0\u00bbnone\u00a0\u00bb tablet_sm_visibility=\u00a0\u00bbhide\u00a0\u00bb mobile_visibility=\u00a0\u00bbhide\u00a0\u00bb bg_color=\u00a0\u00bb#ffffff\u00a0\u00bb el_class=\u00a0\u00bbblocDynamiquePrestations2″][vc_column vertical_content_position=\u00a0\u00bbmiddle\u00a0\u00bb column_custom_position=\u00a0\u00bbyes\u00a0\u00bb position_top=\u00a0\u00bbminus-3x\u00a0\u00bb width=\u00a0\u00bb1\/2″ clipping_animation=\u00a0\u00bbclipping-up\u00a0\u00bb el_wrapper_class=\u00a0\u00bbblocRollDispositifsPrestations\u00a0\u00bb][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574892910627{padding-top: 7% !important;padding-right: 10% !important;padding-bottom: 7% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs1″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

AFFAIRES R\u00c9GLEMENTAIRES<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>R\u00e9daction et mise \u00e0 jour de dossiers de marquage CE\/510k<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Veille r\u00e9glementaire<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>R\u00e9ponses aux questions des organismes notifi\u00e9s et autorit\u00e9s de sant\u00e9<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Soumission \u00e0 l\u2019export (worldwide)<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574959336719{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs2″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]
<\/div>

GESTION DES RISQUES<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>M\u00e9thodologie AMDEC (FMEA) sur les produits et les process<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>D\u00e9finition du plan de gestion des risques et mise \u00e0 jour \/ cr\u00e9ation du DGR<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>B\u00e9n\u00e9fices \/ risques<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574959412651{padding-top: 7% !important;padding-right: 10% !important;padding-bottom: 7% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs3″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

DESIGN TRANSFER<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Design input, output, v\u00e9rification et validation<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>R\u00e9daction et mise \u00e0 jour des DMR\/DHF\/DHR<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Gestion des \u00e9changes entre la R&D et la production<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>M\u00e9thodes \/ indus : mise en place des gammes de contr\u00f4le<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574959473494{padding-top: 6% !important;padding-right: 10% !important;padding-bottom: 6% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs4″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

SYST\u00c8ME DE MANAGEMENT DE LA QUALIT\u00c9<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Cr\u00e9ation et r\u00e9vision du SMQ selon l\u2019ISO 13485 (version en vigueur)<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Pr\u00e9paration des audits et gestion des r\u00e9ponses post audit<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Formation, sensibilisation, accompagnement du personnel dans la d\u00e9marche qualit\u00e9<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574959539042{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs5″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]
<\/div>

SYSTEM ENGINEERING<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Gestion des syst\u00e8mes \u00e9lectrom\u00e9dicaux (sp\u00e9cifications, plan de tests, tests)<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>V&V selon les normes IEC 62304, 60601<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>R\u00e9daction sp\u00e9cifications techniques et fonctionnelles, CDC, URS<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574893084915{padding-top: 13% !important;padding-right: 10% !important;padding-bottom: 13% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs6″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]
<\/div>

AUDIT & CONSEIL<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Diagnostic qualit\u00e9 et r\u00e9glementaire<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Accompagnement dans le montage des plans d\u2019actions<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Accompagnement au changement<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574959697276{padding-top: 9% !important;padding-right: 10% !important;padding-bottom: 9% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs7″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

MEDICAL DEVICE REGULATION<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Mise en conformit\u00e9 des sites clients au nouveau r\u00e8glement<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>PMS, UDI, clinique, changements de classe du DM<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Pilotage des change control, impl\u00e9mentation des changements<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574959589130{padding-top: 9% !important;padding-right: 10% !important;padding-bottom: 9% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs8″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

\u00c9VALUATION CLINIQUE & BIOLOGIQUE<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>R\u00e9daction de rapports d\u2019\u00e9valuation clinique et biologique<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>R\u00e9cup\u00e9ration des donn\u00e9es (\u00e9tudes cliniques ou donn\u00e9es essais in vivo et in vitro), recherche bibliographique<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Mise en conformit\u00e9 par rapport au MEDDEV 2.7.1 rev4 & MDR<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574893173682{padding-top: 10% !important;padding-right: 10% !important;padding-bottom: 10% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs9″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

VALIDATION DE PROC\u00c9D\u00c9S SP\u00c9CIAUX<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Nettoyage, conditionnement des DM, st\u00e9rilisation (ETO, gamma, autoclaves), marquage et gravure laser, etc\u2026<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>D\u00e9finition des strat\u00e9gies et des worst case, d\u00e9finition des plans d\u2019\u00e9chantillonnages<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Gestion des essais avec les sous-traitants<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574959748714{padding-top: 9% !important;padding-right: 10% !important;padding-bottom: 9% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs10″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

VALIDATION DES SYST\u00c8MES INFORMATIS\u00c9S<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Validation des syst\u00e8mes informatis\u00e9s (environnement GAMP5, 21CFR part11)<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>ERP, GED, syst\u00e8mes de production automatis\u00e9s<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Tests d\u2019int\u00e9gration, logiciels, unitaires, non-r\u00e9gression<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574959847020{padding-top: 13% !important;padding-right: 10% !important;padding-bottom: 13% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs11″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]
<\/div>

QUALIFICATION D\u2019\u00c9QUIPEMENTS<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>\u00c9quipements de laboratoire, de production<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>FAT, SAT, QI, QO, QP<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>VMP, protocoles, rapports<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574893356621{padding-top: 11% !important;padding-right: 10% !important;padding-bottom: 11% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs12″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]
<\/div>

ASSURANCE QUALIT\u00c9 OP\u00c9RATIONNELLE<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Traitement des \u00e9v\u00e8nements qualit\u00e9 \/ NC \/ CAPA \/ Change control<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Coordination des plans d\u2019actions qualit\u00e9<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Gestion de la qualit\u00e9 aupr\u00e8s des fournisseurs, production et laboratoire<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column column_custom_position=\u00a0\u00bbyes\u00a0\u00bb position_top=\u00a0\u00bbminus-3x\u00a0\u00bb width=\u00a0\u00bb1\/2″ animation_delay=\u00a0\u00bb400″ el_wrapper_class=\u00a0\u00bbblocMenuDispositifsPrestations\u00a0\u00bb]

01 <\/span>AFFAIRES R\u00c9GLEMENTAIRES
\n<\/span>02 <\/span>GESTION DES RISQUES
\n<\/span>03 <\/span>DESIGN TRANSFER
\n<\/span>04 <\/span>SYST\u00c8ME DE MANAGEMENT DE LA QUALIT\u00c9
\n<\/span>05 <\/span>SYSTEM ENGINEERING
\n<\/span>06 <\/span>AUDIT & CONSEIL
\n<\/span>07 <\/span>MEDICAL DEVICE REGULATION<\/span>
\n08 <\/span>\u00c9VALUATION CLINIQUE & BIOLOGIQUE<\/span>
\n09 <\/span>VALIDATION DE PROC\u00c9D\u00c9S SP\u00c9CIAUX<\/span>
\n10 <\/span>VALIDATION DES SYST\u00c8MES INFORMATIS\u00c9S<\/span>
\n<\/span>11 <\/span>QUALIFICATION D\u2019\u00c9QUIPEMENTS<\/span>
\n12 <\/span>ASSURANCE QUALIT\u00c9 OP\u00c9RATIONNELLE<\/span><\/span><\/span><\/h4>
<\/div>[\/vc_column][\/vc_row][vc_row section_type=\u00a0\u00bbfullwidth\u00a0\u00bb bg_type=\u00a0\u00bbcolor\u00a0\u00bb padding_top_multiplier=\u00a0\u00bb\u00a0\u00bb padding_bottom_multiplier=\u00a0\u00bb\u00a0\u00bb columns_gap=\u00a0\u00bbnone\u00a0\u00bb desktop_visibility=\u00a0\u00bbhide\u00a0\u00bb tablet_visibility=\u00a0\u00bbhide\u00a0\u00bb bg_color=\u00a0\u00bb#ffffff\u00a0\u00bb el_class=\u00a0\u00bbblocDynamiquePrestations2″][vc_column vertical_content_position=\u00a0\u00bbmiddle\u00a0\u00bb width=\u00a0\u00bb1\/2″ animation_delay=\u00a0\u00bb400″ el_wrapper_class=\u00a0\u00bbblocMenuDispositifsPrestations\u00a0\u00bb]

01 <\/span>AFFAIRES R\u00c9GLEMENTAIRES
\n<\/span>02 <\/span>GESTION DES RISQUES
\n<\/span>03 <\/span>DESIGN TRANSFER<\/span>
\n04 <\/span>SYST\u00c8ME DE MANAGEMENT DE LA QUALIT\u00c9
\n<\/span>05 <\/span>SYSTEM ENGINEERING
\n<\/span>06 <\/span>AUDIT & CONSEIL
\n<\/span>07 <\/span>MEDICAL DEVICE REGULATION
\n<\/span>08 <\/span>\u00c9VALUATION CLINIQUE & BIOLOGIQUE
\n<\/span>09 <\/span>VALIDATION DE PROC\u00c9D\u00c9S SP\u00c9CIAUX
\n<\/span>10 <\/span>VALIDATION DES SYST\u00c8MES INFORMATIS\u00c9S
\n<\/span>11 <\/span>QUALIFICATION D\u2019\u00c9QUIPEMENTS
\n<\/span>12 <\/span>ASSURANCE QUALIT\u00c9 OP\u00c9RATIONNELLE<\/span><\/span><\/span><\/h4>
<\/div>[\/vc_column][vc_column width=\u00a0\u00bb1\/2″ el_wrapper_class=\u00a0\u00bbblocRollDispositifsPrestations\u00a0\u00bb][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960110648{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs1″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

AFFAIRES R\u00c9GLEMENTAIRES<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>R\u00e9daction et mise \u00e0 jour de dossiers de marquage CE\/510k<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Veille r\u00e9glementaire<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>R\u00e9ponses aux questions des organismes notifi\u00e9s et autorit\u00e9s de sant\u00e9<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Soumission \u00e0 l\u2019export (worldwide)<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960117404{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs2″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

GESTION DES RISQUES<\/span><\/span><\/h4>
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\u2022 <\/span>M\u00e9thodologie AMDEC (FMEA) sur les produits et les process<\/span><\/span><\/h5>
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\u2022 <\/span>D\u00e9finition du plan de gestion des risques et mise \u00e0 jour \/ cr\u00e9ation du DGR<\/span><\/span><\/h5>
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\u2022 <\/span>B\u00e9n\u00e9fices \/ risques<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960124848{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs3″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

DESIGN TRANSFER<\/span><\/span><\/h4>
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\u2022 <\/span>Design input, output, v\u00e9rification et validation<\/span><\/span><\/h5>
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\u2022 <\/span>R\u00e9daction et mise \u00e0 jour des DMR\/DHF\/DHR<\/span><\/span><\/h5>
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\u2022 <\/span>Gestion des \u00e9changes entre la R&D et la production<\/span><\/span><\/h5>
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\u2022 <\/span>M\u00e9thodes \/ indus : mise en place des gammes de contr\u00f4le<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960184325{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs4″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

SYST\u00c8ME DE MANAGEMENT DE LA QUALIT\u00c9<\/span><\/span><\/h4>
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\u2022 <\/span>Cr\u00e9ation et r\u00e9vision du SMQ selon l\u2019ISO 13485 (version en vigueur)<\/span><\/span><\/h5>
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\u2022 <\/span>Pr\u00e9paration des audits et gestion des r\u00e9ponses post audit<\/span><\/span><\/h5>
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\u2022 <\/span>Formation, sensibilisation, accompagnement du personnel dans la d\u00e9marche qualit\u00e9<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960192334{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs5″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

SYSTEM ENGINEERING<\/span><\/span><\/h4>
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\u2022 <\/span>Gestion des syst\u00e8mes \u00e9lectrom\u00e9dicaux (sp\u00e9cifications, plan de tests, tests)<\/span><\/span><\/h5>
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\u2022 <\/span>V&V selon les normes IEC 62304, 60601<\/span><\/span><\/h5>
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\u2022 <\/span>R\u00e9daction sp\u00e9cifications techniques et fonctionnelles, CDC, URS<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960201304{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs6″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

AUDIT & CONSEIL<\/span><\/span><\/h4>
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\u2022 <\/span>Diagnostic qualit\u00e9 et r\u00e9glementaire<\/span><\/span><\/h5>
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\u2022 <\/span>Accompagnement dans le montage des plans d\u2019actions<\/span><\/span><\/h5>
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\u2022 <\/span>Accompagnement au changement<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960208502{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs7″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

MEDICAL DEVICE REGULATION<\/span><\/span><\/h4>
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\u2022 <\/span>Mise en conformit\u00e9 des sites clients au nouveau r\u00e8glement<\/span><\/span><\/h5>
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\u2022 <\/span>PMS, UDI, clinique, changements de classe du DM<\/span><\/span><\/h5>
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\u2022 <\/span>Pilotage des change control, impl\u00e9mentation des changements<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960214312{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs8″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

\u00c9VALUATION CLINIQUE & BIOLOGIQUE<\/span><\/span><\/h4>
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\u2022 <\/span>R\u00e9daction de rapports d\u2019\u00e9valuation clinique et biologique<\/span><\/span><\/h5>
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\u2022 <\/span>R\u00e9cup\u00e9ration des donn\u00e9es (\u00e9tudes cliniques ou donn\u00e9es essais in vivo et in vitro), recherche bibliographique<\/span><\/span><\/h5>
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\u2022 <\/span>Mise en conformit\u00e9 par rapport au MEDDEV 2.7.1 rev4 & MDR<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960221054{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs9″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

VALIDATION DE PROC\u00c9D\u00c9S SP\u00c9CIAUX<\/span><\/span><\/h4>
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\u2022 <\/span>Nettoyage, conditionnement des DM, st\u00e9rilisation (ETO, gamma, autoclaves), marquage et gravure laser, etc\u2026<\/span><\/span><\/h5>
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\u2022 <\/span>D\u00e9finition des strat\u00e9gies et des worst case, d\u00e9finition des plans d\u2019\u00e9chantillonnages<\/span><\/span><\/h5>
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\u2022 <\/span>Gestion des essais avec les sous-traitants<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960228746{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs10″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

VALIDATION DES SYST\u00c8MES INFORMATIS\u00c9S<\/span><\/span><\/h4>
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\u2022 <\/span>Validation des syst\u00e8mes informatis\u00e9s (environnement GAMP5, 21CFR part11)<\/span><\/span><\/h5>
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\u2022 <\/span>ERP, GED, syst\u00e8mes de production automatis\u00e9s<\/span><\/span><\/h5>
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\u2022 <\/span>Tests d\u2019int\u00e9gration, logiciels, unitaires, non-r\u00e9gression<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960236420{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs11″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

QUALIFICATION D\u2019\u00c9QUIPEMENTS<\/span><\/span><\/h4>
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\u2022 <\/span>\u00c9quipements de laboratoire, de production<\/span><\/span><\/h5>
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\u2022 <\/span>FAT, SAT, QI, QO, QP<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>VMP, protocoles, rapports<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner css=\u00a0\u00bb.vc_custom_1574960246024{padding-top: 8% !important;padding-right: 10% !important;padding-bottom: 8% !important;padding-left: 10% !important;background-color: #000000 !important;}\u00a0\u00bb el_class=\u00a0\u00bbBlocPrestationsDispositifs12″ el_wrapper_class=\u00a0\u00bbBlackBlocRollPrestations\u00a0\u00bb]

ASSURANCE QUALIT\u00c9 OP\u00c9RATIONNELLE<\/span><\/span><\/h4>
<\/span><\/div>
<\/div>
\u2022 <\/span>Traitement des \u00e9v\u00e8nements qualit\u00e9 \/ NC \/ CAPA \/ Change control<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Coordination des plans d\u2019actions qualit\u00e9<\/span><\/span><\/h5>
<\/div>
\u2022 <\/span>Gestion de la qualit\u00e9 aupr\u00e8s des fournisseurs, production et laboratoire<\/span><\/span><\/h5>[\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"

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