{"id":279369,"date":"2025-04-16T13:14:40","date_gmt":"2025-04-16T13:14:40","guid":{"rendered":"https:\/\/devmk.fle-media.de\/?page_id=279369"},"modified":"2025-08-29T10:34:44","modified_gmt":"2025-08-29T10:34:44","slug":"qualification-pharma","status":"publish","type":"page","link":"https:\/\/devmk.fle-media.de\/en\/pharmaceutical_technology\/service-after-sales-pharmaceutical-technology\/qualification-pharma\/","title":{"rendered":"Qualification Pharma"},"content":{"rendered":"

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Ensuring system compliance through comprehensive testing<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”section” _builder_version=”4.25.2″ _module_preset=”default” width=”100%” custom_margin=”0px||0px||true|false” custom_padding=”0px||0px||true|false” da_disable_devices=”off|off|off” global_module=”275416″ global_colors_info=”{}” da_is_popup=”off” da_exit_intent=”off” da_has_close=”on” da_alt_close=”off” da_dark_close=”off” da_not_modal=”on” da_is_singular=”off” da_with_loader=”off” da_has_shadow=”on”][et_pb_row _builder_version=”4.25.2″ _module_preset=”default” custom_margin=”0px||0px||true|false” custom_padding=”5px||5px||true|false” locked=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.23.4″ _module_preset=”default” global_colors_info=”{}”][dsm_breadcrumbs show_home_icon=”off” _builder_version=”4.25.2″ _module_preset=”default” items_font=”|600|||||||” items_text_color=”#000000″ separators_text_color=”#878787″ current_font=”|600|||||||” current_text_color=”#E02B20″ locked=”off” global_colors_info=”{}”][\/dsm_breadcrumbs][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Features” _builder_version=”4.25.0″ _module_preset=”default” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” da_disable_devices=”off|off|off” locked=”off” collapsed=”on” global_colors_info=”{}” da_is_popup=”off” da_exit_intent=”off” da_has_close=”on” da_alt_close=”off” da_dark_close=”off” da_not_modal=”on” da_is_singular=”off” da_with_loader=”off” da_has_shadow=”on”][et_pb_row column_structure=”3_5,2_5″ make_equal=”on” _builder_version=”4.27.4″ _module_preset=”5138c454-be54-4233-bd3b-f8e6a8747976″ background_color=”gcid-595efaaa-1798-4678-9685-46de2a72c3d8″ min_height=”550px” custom_margin=”||57px||false|false” custom_padding=”0px||0px||true|true” global_colors_info=”{%22gcid-595efaaa-1798-4678-9685-46de2a72c3d8%22:%91%22background_color%22%93}” custom_css_main_element_last_edited=”on|phone”][et_pb_column type=”3_5″ _builder_version=”4.25.0″ _module_preset=”73121f80-a3ef-4484-8763-c3f18e3c56d2″ custom_padding=”40px|||40px|false|false” custom_padding_tablet=”20px|20px|20px|20px|true|true” custom_padding_phone=”20px|20px|20px|20px|true|true” custom_padding_last_edited=”on|tablet” global_colors_info=”{}”][et_pb_text ul_position=”inside” quote_border_color=”#f3f3f3″ _builder_version=”4.27.4″ _module_preset=”2c55a9c4-feed-423b-9edb-ae0b5b365cac” text_font=”Open Sans|Open Sans_weight|||||||” text_text_color=”#3c3a47″ text_font_size=”18px” text_line_height=”1.75em” link_font=”|Open Sans_weight|||||||” link_text_color=”#e02b20″ ul_font_size=”17px” ul_line_height=”2em” quote_font=”Roboto|Roboto_weight|||||||” quote_text_color=”#0e0c19″ header_font=”Roboto|Roboto_weight|||||||” header_text_color=”#0e0c19″ header_line_height=”1.15em” header_2_font=”Roboto|Roboto_weight|||||||” header_2_text_color=”#0e0c19″ header_2_font_size=”50px” header_2_line_height=”1.2em” header_3_font=”Roboto|Roboto_weight|||||||” header_3_text_color=”#0e0c19″ header_3_font_size=”32px” header_3_line_height=”1.3em” header_4_font=”Roboto|Roboto_weight|||||||” header_4_text_color=”#0e0c19″ header_4_font_size=”24px” header_4_line_height=”1.4em” header_5_text_color=”#0e0c19″ header_6_font=”Roboto|Roboto_weight|||||||” header_6_text_color=”#0e0c19″ header_6_line_height=”1.5em” custom_margin=”||||false|false” header_font_size_tablet=”40px” header_font_size_phone=”24px” header_font_size_last_edited=”on|desktop” header_2_font_size_tablet=”28px” header_2_font_size_phone=”20px” header_2_font_size_last_edited=”on|phone” header_3_font_size_tablet=”22px” header_3_font_size_phone=”17px” header_3_font_size_last_edited=”on|phone” header_4_font_size_tablet=”18px” header_4_font_size_phone=”15px” header_4_font_size_last_edited=”on|tablet” header_6_font_size_tablet=”13px” header_6_font_size_phone=”13px” header_6_font_size_last_edited=”on|desktop” custom_css_free_form=”ul {padding-top:10px !important}” locked=”off” global_colors_info=”{}”]<\/p>\n

Thorough qualification is essential to ensure that your equipment and systems meet the highest regulatory requirements. MK Versuchsanlagen GmbH & Co. KG offers comprehensive testing that complies with all legal regulations and industry-specific standards.<\/p>\n

Our qualification services include:<\/p>\n

FAT (Factory Acceptance Test) \u2013 Quality inspection during manufacturing<\/strong>
The FAT ensures that your systems meet all specifications even before delivery. We test all functions at our facility to guarantee seamless integration into your processes.<\/p>\n

SAT (Site Acceptance Test) <\/strong>\u2013 Testing under real operating conditions
After installation, the SAT is performed to confirm flawless on-site functionality. This includes:
\u2022 IQ (Installation Qualification)<\/strong>
\u2022 OQ (Operational Qualification)<\/strong>
\u2022 PQ (Performance Qualification)<\/strong><\/p>\n

Detailed documentation <\/strong>– Traceability and assurance
For each qualification stage (IQ, OQ, PQ), we prepare comprehensive protocols that document all performed tests, measurements, and results in detail. This provides you with transparent verification records required for both internal quality control and audits by authorities or certification bodies.<\/p>\n

Additionally, upon delivery, we provide a complete project documentation package, including the following documents:
\u2022 Project & qualification documents
\u2022 Calibration certificates
\u2022 Operating manuals
\u2022 Certificate of conformity
\u2022 Quality \/ material certificates
\u2022 Protection class certificate<\/p>\n

With our precise qualification process, we ensure that your systems operate in a compliant, safe, and efficient manner.

Contact us \u2013 we will support you reliably throughout the entire qualification process!<\/p>\n

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Contact<\/h2>\n

Contact us for guidance on your project<\/p>\n

[\/et_pb_text][et_pb_button button_url=”tel:+4964009576030″ button_text=”+49 6400 957 603-0″ button_alignment=”left” button_alignment_tablet=”center” button_alignment_phone=”center” button_alignment_last_edited=”on|desktop” module_class=”kontakt_button” _builder_version=”4.25.2″ _module_preset=”default” button_border_width=”0px” button_icon=”||fa||900″ button_icon_placement=”left” button_on_hover=”off” custom_margin=”||||false|false” locked=”off” global_colors_info=”{}” custom_css_main_element_last_edited=”off|desktop” custom_css_main_element_tablet=”float: none;” custom_css_main_element_phone=”float: none;”][\/et_pb_button][et_pb_button button_url=”https:\/\/devmk.fle-media.de\/en\/contact\/” button_text=”Contact form” button_alignment=”left” button_alignment_tablet=”center” button_alignment_phone=”center” button_alignment_last_edited=”on|tablet” module_id=”sec” module_class=”kontakt_button” _builder_version=”4.25.2″ _module_preset=”default” button_border_width=”0px” button_letter_spacing=”1px” button_icon=”||fa||400″ button_icon_placement=”left” button_on_hover=”off” custom_margin=”||||false|false” custom_css_free_form=”@media (min-width:1415px){|| .kontakt_button{|| float: left;|| }|| #sec{|| margin-left: 20px;|| }||}||||@media (max-width:340px){|||| #sec{|| font-size:18px !important;|| }||}” locked=”off” global_colors_info=”{}” custom_css_main_element_last_edited=”off|desktop” custom_css_main_element_tablet=”float:none;” custom_css_main_element_phone=”float:none;”][\/et_pb_button][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.23.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_text content_tablet=”<\/p>\n

Talk to ourexperts .<\/span><\/p>\n

” content_phone=”<\/p>\n

Talk to our experts.<\/span><\/p>\n

” content_last_edited=”on|phone” _builder_version=”4.27.4″ _module_preset=”default” text_font=”|600|||||||” text_text_color=”#636363″ text_font_size=”51px” text_line_height=”1.1em” custom_margin_tablet=”” custom_margin_phone=”||||false|true” custom_margin_last_edited=”on|phone” custom_padding=”||||false|false” text_font_size_tablet=”” text_font_size_phone=”40px” text_font_size_last_edited=”on|tablet” global_colors_info=”{}” content__hover_enabled=”off|desktop”]<\/p>\n

Talk to our experts.<\/span><\/p>\n

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Ensuring system compliance through comprehensive testing

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