[et_pb_section fb_built=”1″ prev_background_color=”#ffffff” _builder_version=”4.14.7″ background_enable_color=”off” background_image=”https:\/\/oytec.es\/wp-content\/uploads\/2023\/04\/EBR_HEADER.jpg” z_index=”10″ custom_margin=”||21px|||” custom_padding=”||36px|||” top_divider_style=”arrow” top_divider_height=”30px” hover_enabled=”0″ z_index_tablet=”500″ global_colors_info=”{}” title_text=”EBR_HEADER” sticky_enabled=”0″][et_pb_row module_class=” et_pb_row_fullwidth” _builder_version=”4.9.2″ width_tablet=”80%” width_phone=”” width_last_edited=”on|desktop” max_width=”80%” max_width_tablet=”80%” max_width_phone=”” max_width_last_edited=”on|desktop” custom_padding=”49px||0px|||” z_index_tablet=”500″ make_fullwidth=”on” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.14.7″ _module_preset=”default” text_font=”Roboto|700|||||||” text_text_color=”#FFFFFF” text_font_size=”45px” text_line_height=”1em” background_layout=”dark” custom_margin=”||12.5%||false|false” custom_padding=”0px||||false|false” animation_direction=”right” hover_enabled=”0″ text_text_shadow_style=”preset5″ text_text_shadow_horizontal_length=”-0.02em” text_text_shadow_blur_strength=”0.1em” locked=”off” global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n
ELECTRONIC BATCH RECORDING (eBR)<\/p>\n
[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.14.7″ _module_preset=”default” custom_padding=”29px||12px|||” global_colors_info=”{}” locked=”off”][et_pb_row column_structure=”1_5,1_5,1_5,1_5,1_5″ _builder_version=”4.14.7″ _module_preset=”default” custom_padding=”||54px|||” global_colors_info=”{}”][et_pb_column type=”1_5″ _builder_version=”4.14.7″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.14.7″ _module_preset=”default” text_text_color=”#23408f” text_font_size=”55px” text_orientation=”center” global_colors_info=”{}”]<\/p>\n
+95%<\/strong><\/p>\n [\/et_pb_text][et_pb_text _builder_version=”4.14.7″ _module_preset=”default” text_font_size=”20px” text_orientation=”center” global_colors_info=”{}”]<\/p>\n Right First Time<\/span><\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_5″ _builder_version=”4.14.7″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.14.7″ _module_preset=”default” text_text_color=”#23408f” text_font_size=”55px” text_orientation=”center” global_colors_info=”{}”]<\/p>\n -75%<\/strong><\/p>\n [\/et_pb_text][et_pb_text _builder_version=”4.14.7″ _module_preset=”default” text_font_size=”20px” text_orientation=”center” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n Deviations in the Batch Record<\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_5″ _builder_version=”4.14.7″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.14.7″ _module_preset=”default” text_text_color=”#23408f” text_font_size=”55px” text_orientation=”center” global_colors_info=”{}”]<\/p>\n -75%<\/strong><\/p>\n [\/et_pb_text][et_pb_text _builder_version=”4.14.7″ _module_preset=”default” text_font_size=”20px” text_orientation=”center” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n Batch Record review time<\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_5″ _builder_version=”4.14.7″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.14.7″ _module_preset=”default” text_text_color=”#23408f” text_font_size=”55px” text_orientation=”center” global_colors_info=”{}”]<\/p>\n -75%<\/strong><\/p>\n [\/et_pb_text][et_pb_text _builder_version=”4.14.7″ _module_preset=”default” text_font_size=”20px” text_orientation=”center” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n Data input times<\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_5″ _builder_version=”4.14.7″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.14.7″ _module_preset=”default” text_text_color=”#23408f” text_font_size=”30px” text_line_height=”0.3em” text_orientation=”center” custom_margin=”-11px|-23px|10px|-23px|false|false” global_colors_info=”{}”]<\/p>\n 21 CFR <\/span>Part<\/span> 11 <\/span><\/strong><\/p>\n Compliance<\/span><\/strong><\/p>\n [\/et_pb_text][et_pb_text _builder_version=”4.14.7″ _module_preset=”default” text_font_size=”20px” text_orientation=”center” custom_margin=”27px|||||” global_colors_info=”{}”]<\/p>\n \u00a0GMP & FDA Compliance<\/span><\/span><\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.14.7″ width=”100%” custom_margin=”9px||2px|||” custom_padding=”29px||0px|||” bottom_divider_height=”114px” global_colors_info=”{}” locked=”off”][et_pb_row column_structure=”1_2,1_2″ _builder_version=”4.14.7″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_margin=”-1.2%|auto||auto|false|false” custom_padding=”22px||35px|||” global_colors_info=”{}”][et_pb_column type=”1_2″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.14.7″ text_font=”||||||||” text_font_size=”17px” text_orientation=”justified” custom_padding=”||0px|||” animation_direction=”left” hover_enabled=”0″ z_index_tablet=”500″ global_colors_info=”{}” width__hover_enabled=”on|hover” sticky_enabled=”0″]<\/p>\n The substitution of the paper manufacturing guide with an electronic guide or Electronic Batch Recording (eBR) represents a strategic decision that requires the direct involvement of general management due to its impact on the policies and procedures governing the company. Moreover, its effect will be very cross-functional, affecting most of the factory’s departments.<\/span>\u00a0<\/span><\/p>\n The implementation of an Electronic Guide will enable us to manage and track manufacturing orders, as well as the materials and equipment (Electronic Logbooks) involved in them. We will have real-time inventory information, the flow of materials (MFC) involved in the manufacturing order, and their status. Through the EBR, we will manage manufacturing instructions interactively, predefining workflow processes and accurately sequencing the different steps to be executed. All of this will be done electronically with real-time exception-based review.<\/span>\u00a0<\/span><\/p>\n <\/span><\/p>\n <\/span><\/p>\n <\/p>\n <\/span><\/p>\n <\/span><\/p>\n <\/span><\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”3.25″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_image src=”https:\/\/oytec.es\/wp-content\/uploads\/2023\/04\/EBR.jpg” title_text=”EBR” _builder_version=”4.14.7″ _module_preset=”default” custom_padding=”0px|||||” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.14.7″ _module_preset=”default” background_color=”#eef1f7″ background_image=”https:\/\/www.oytec.es\/wp-content\/uploads\/2021\/03\/Footer_Oytec_400.jpg” background_enable_image=”off” custom_margin=”-1px|||||” custom_padding=”3px||70px|||” global_module=”7175″ saved_tabs=”all” global_colors_info=”{}”][et_pb_row column_structure=”1_4,1_4,1_4,1_4″ _builder_version=”4.14.7″ _module_preset=”default” module_alignment=”center” global_colors_info=”{}”][et_pb_column type=”1_4″ _builder_version=”4.9.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.14.7″ _module_preset=”default” custom_margin=”-9px||20px||false|false” locked=”off” global_colors_info=”{}”]<\/p>\n BARCELONA<\/strong><\/p>\n [\/et_pb_text][et_pb_text admin_label=”Texto” _builder_version=”4.14.7″ text_font=”Roboto||||||||” header_3_font=”|||on|||||” header_6_text_color=”#7c7c7c” background_layout=”dark” custom_padding=”0px|||||” z_index_tablet=”500″ global_colors_info=”{}”]<\/p>\n