{"id":160353,"date":"2025-11-18T19:04:59","date_gmt":"2025-11-18T19:04:59","guid":{"rendered":"https:\/\/www.en-com.it\/?page_id=160353"},"modified":"2025-11-20T09:10:53","modified_gmt":"2025-11-20T09:10:53","slug":"validation-3","status":"publish","type":"page","link":"https:\/\/www.en-com.it\/en\/validation-3\/","title":{"rendered":"VALIDATION &amp; CHANGE CONTROL"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row unlock_row_content=&#8221;yes&#8221; row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;1&#8243; top_padding=&#8221;1&#8243; bottom_padding=&#8221;1&#8243; back_color=&#8221;accent&#8221; overlay_alpha=&#8221;50&#8243; equal_height=&#8221;yes&#8221; gutter_size=&#8221;1&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; content_parallax=&#8221;0&#8243; uncode_shortcode_id=&#8221;214697&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_column column_width_percent=&#8221;100&#8243; position_vertical=&#8221;bottom&#8221; gutter_size=&#8221;3&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;3&#8243; style=&#8221;dark&#8221; back_color=&#8221;accent&#8221; overlay_alpha=&#8221;100&#8243; overlay_color_blend=&#8221;multiply&#8221; overlay_animated=&#8221;yes&#8221; overlay_animated_1_color=&#8221;accent&#8221; overlay_animated_size=&#8221;0.35&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;8\/12&#8243; mobile_height=&#8221;55vh&#8221; uncode_shortcode_id=&#8221;336829&#8243; overlay_color_type=&#8221;uncode-solid&#8221; overlay_color_solid=&#8221;rgba(74,26,43,0.74)&#8221; back_color_type=&#8221;uncode-palette&#8221; overlay_animated_1_color_type=&#8221;uncode-palette&#8221; overlay_animated_2_color_type=&#8221;uncode-solid&#8221; overlay_animated_2_color_solid=&#8221;rgba(74,26,43,0.68)&#8221;][vc_empty_space empty_h=&#8221;3&#8243;][vc_custom_heading text_color=&#8221;color-xsdn&#8221; heading_semantic=&#8221;h1&#8243; text_font=&#8221;font-156269&#8243; text_size=&#8221;fontsize-445851&#8243; text_weight=&#8221;800&#8243; text_transform=&#8221;uppercase&#8221; text_space=&#8221;fontspace-781688&#8243; uncode_shortcode_id=&#8221;433021&#8243; text_color_type=&#8221;uncode-palette&#8221;]VALIDATION &amp; CHANGE CONTROL[\/vc_custom_heading][\/vc_column][vc_column column_width_percent=&#8221;100&#8243; position_vertical=&#8221;justify&#8221; gutter_size=&#8221;1&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;4\/12&#8243; uncode_shortcode_id=&#8221;160146&#8243;][vc_row_inner row_inner_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;129174&#8243; limit_content=&#8221;&#8221;][vc_column_inner column_width_percent=&#8221;50&#8243; position_horizontal=&#8221;left&#8221; gutter_size=&#8221;2&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;3&#8243; back_color=&#8221;color-lxmt&#8221; back_image=&#8221;156663&#8243; back_position=&#8221;right center&#8221; overlay_color=&#8221;color-xsdn&#8221; overlay_alpha=&#8221;81&#8243; overlay_color_blend=&#8221;multiply&#8221; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;638693&#8243; back_color_type=&#8221;uncode-palette&#8221; overlay_color_type=&#8221;uncode-palette&#8221; mobile_height=&#8221;400&#8243;][vc_empty_space empty_h=&#8221;5&#8243;][\/vc_column_inner][\/vc_row_inner][vc_row_inner row_inner_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; equal_height=&#8221;yes&#8221; gutter_size=&#8221;0&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;191702&#8243; limit_content=&#8221;&#8221;][vc_column_inner column_width_percent=&#8221;100&#8243; position_vertical=&#8221;bottom&#8221; gutter_size=&#8221;2&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;3&#8243; back_color=&#8221;color-xsdn&#8221; overlay_alpha=&#8221;100&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;4&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; mobile_height=&#8221;300&#8243; uncode_shortcode_id=&#8221;204952&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_custom_heading heading_semantic=&#8221;h3&#8243; text_font=&#8221;font-156269&#8243; text_size=&#8221;h1&#8243; text_weight=&#8221;800&#8243; text_space=&#8221;fontspace-781688&#8243; uncode_shortcode_id=&#8221;223160&#8243;]Structured Service<\/p>\n<p>[\/vc_custom_heading][vc_custom_heading heading_semantic=&#8221;h6&#8243; text_font=&#8221;font-156269&#8243; text_size=&#8221;h4&#8243; text_weight=&#8221;400&#8243; text_height=&#8221;fontheight-357766&#8243; text_space=&#8221;fontspace-781688&#8243; uncode_shortcode_id=&#8221;109314&#8243;]We ensure that facilities, systems, and processes operate in full compliance with regulatory requirements and industry quality standards.<br data-start=\"328\" data-end=\"331\">We manage the entire validation lifecycle, guaranteeing process traceability, consistency, and robustness.<br data-start=\"507\" data-end=\"510\">Our approach to Change Control allows us to assess, approve, and implement every modification in a controlled manner, minimizing risks and preserving the integrity of the validated state.[\/vc_custom_heading][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row unlock_row_content=&#8221;yes&#8221; row_height_percent=&#8221;30&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;0&#8243; top_padding=&#8221;0&#8243; bottom_padding=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; equal_height=&#8221;yes&#8221; gutter_size=&#8221;0&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_visibility=&#8221;yes&#8221; mobile_visibility=&#8221;yes&#8221; inverted_device_order=&#8221;yes&#8221; auto_height_device=&#8221;yes&#8221; content_parallax=&#8221;0&#8243; uncode_shortcode_id=&#8221;991787&#8243;][vc_column column_width_percent=&#8221;100&#8243; position_vertical=&#8221;middle&#8221; gutter_size=&#8221;3&#8243; back_color=&#8221;color-wvjs&#8221; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; css_animation=&#8221;bottom-t-top&#8221; animation_delay=&#8221;200&#8243; width=&#8221;1\/3&#8243; uncode_shortcode_id=&#8221;708207&#8243; mobile_height=&#8221;360&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_single_image media=&#8221;160545&#8243; media_width_percent=&#8221;15&#8243; uncode_shortcode_id=&#8221;202490&#8243;][vc_custom_heading text_color=&#8221;color-xsdn&#8221; text_font=&#8221;font-136269&#8243; text_size=&#8221;h3&#8243; text_weight=&#8221;800&#8243; text_transform=&#8221;uppercase&#8221; text_space=&#8221;fontspace-111509&#8243; text_uppercase=&#8221;&#8221; text_align=&#8221;text-left&#8221; uncode_shortcode_id=&#8221;150279&#8243; text_color_type=&#8221;uncode-palette&#8221;]Validation (URS\/RA\/SI\/VMP\/VS\/VR)[\/vc_custom_heading][\/vc_column][vc_column column_width_percent=&#8221;100&#8243; position_vertical=&#8221;middle&#8221; gutter_size=&#8221;3&#8243; back_color=&#8221;accent&#8221; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/3&#8243; uncode_shortcode_id=&#8221;467348&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_single_image media=&#8221;160534&#8243; media_width_percent=&#8221;15&#8243; uncode_shortcode_id=&#8221;182798&#8243;][vc_custom_heading text_color=&#8221;color-xsdn&#8221; heading_semantic=&#8221;h3&#8243; text_font=&#8221;font-136269&#8243; text_size=&#8221;h3&#8243; text_weight=&#8221;800&#8243; text_transform=&#8221;uppercase&#8221; text_space=&#8221;fontspace-111509&#8243; text_uppercase=&#8221;&#8221; text_align=&#8221;text-left&#8221; uncode_shortcode_id=&#8221;387448&#8243; text_color_type=&#8221;uncode-palette&#8221;]Change Control and C&amp;Q (FAT\/SAT\/DQ\/IQ\/OQ\/PQ\/Maintenance Plans) \u2013 design and execution[\/vc_custom_heading][\/vc_column][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; back_image=&#8221;159943&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/3&#8243; uncode_shortcode_id=&#8221;472957&#8243;][\/vc_column][\/vc_row][vc_row unlock_row_content=&#8221;yes&#8221; row_height_percent=&#8221;30&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;0&#8243; top_padding=&#8221;0&#8243; bottom_padding=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; equal_height=&#8221;yes&#8221; gutter_size=&#8221;0&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; desktop_visibility=&#8221;yes&#8221; inverted_device_order=&#8221;yes&#8221; auto_height_device=&#8221;yes&#8221; content_parallax=&#8221;0&#8243; uncode_shortcode_id=&#8221;310461&#8243;][vc_column column_width_percent=&#8221;100&#8243; position_vertical=&#8221;middle&#8221; gutter_size=&#8221;3&#8243; back_color=&#8221;color-wvjs&#8221; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; css_animation=&#8221;bottom-t-top&#8221; animation_delay=&#8221;200&#8243; width=&#8221;1\/6&#8243; uncode_shortcode_id=&#8221;708207&#8243; mobile_height=&#8221;360&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_single_image media=&#8221;160545&#8243; media_width_percent=&#8221;15&#8243; uncode_shortcode_id=&#8221;202490&#8243;][vc_custom_heading text_color=&#8221;color-xsdn&#8221; text_font=&#8221;font-136269&#8243; text_size=&#8221;h3&#8243; text_weight=&#8221;800&#8243; text_transform=&#8221;uppercase&#8221; text_space=&#8221;fontspace-111509&#8243; text_uppercase=&#8221;&#8221; text_align=&#8221;text-left&#8221; uncode_shortcode_id=&#8221;150279&#8243; text_color_type=&#8221;uncode-palette&#8221;]Validation (URS\/RA\/SI\/VMP\/VS\/VR)[\/vc_custom_heading][\/vc_column][vc_column column_width_percent=&#8221;100&#8243; position_vertical=&#8221;middle&#8221; gutter_size=&#8221;3&#8243; back_color=&#8221;accent&#8221; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/6&#8243; uncode_shortcode_id=&#8221;467348&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_single_image media=&#8221;160534&#8243; media_width_percent=&#8221;15&#8243; uncode_shortcode_id=&#8221;182798&#8243;][vc_custom_heading text_color=&#8221;color-xsdn&#8221; heading_semantic=&#8221;h3&#8243; text_font=&#8221;font-136269&#8243; text_size=&#8221;h3&#8243; text_weight=&#8221;800&#8243; text_transform=&#8221;uppercase&#8221; text_space=&#8221;fontspace-111509&#8243; text_uppercase=&#8221;&#8221; text_align=&#8221;text-left&#8221; uncode_shortcode_id=&#8221;387448&#8243; text_color_type=&#8221;uncode-palette&#8221;]Change Control and C&amp;Q (FAT\/SAT\/DQ\/IQ\/OQ\/PQ\/Maintenance Plans) \u2013 design and execution[\/vc_custom_heading][\/vc_column][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; back_color=&#8221;color-xsdn&#8221; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/6&#8243; uncode_shortcode_id=&#8221;193868&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_single_image media=&#8221;160546&#8243; media_width_percent=&#8221;15&#8243; uncode_shortcode_id=&#8221;270759&#8243;][vc_custom_heading text_color=&#8221;accent&#8221; heading_semantic=&#8221;h3&#8243; text_font=&#8221;font-136269&#8243; text_size=&#8221;h3&#8243; text_weight=&#8221;800&#8243; text_transform=&#8221;uppercase&#8221; text_space=&#8221;fontspace-111509&#8243; text_uppercase=&#8221;&#8221; text_align=&#8221;text-left&#8221; uncode_shortcode_id=&#8221;126598&#8243; text_color_type=&#8221;uncode-palette&#8221;]Technical Reports and Quality Reviews[\/vc_custom_heading][\/vc_column][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; back_color=&#8221;color-wvjs&#8221; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/6&#8243; uncode_shortcode_id=&#8221;123277&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_single_image media=&#8221;160547&#8243; media_width_percent=&#8221;15&#8243; uncode_shortcode_id=&#8221;141744&#8243;][vc_custom_heading text_color=&#8221;color-xsdn&#8221; heading_semantic=&#8221;h3&#8243; text_font=&#8221;font-136269&#8243; text_size=&#8221;h3&#8243; text_weight=&#8221;800&#8243; text_transform=&#8221;uppercase&#8221; text_space=&#8221;fontspace-111509&#8243; text_uppercase=&#8221;&#8221; text_align=&#8221;text-left&#8221; uncode_shortcode_id=&#8221;596524&#8243; text_color_type=&#8221;uncode-palette&#8221;]Standard Operating Procedures (SOPs)[\/vc_custom_heading][\/vc_column][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; back_color=&#8221;accent&#8221; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/6&#8243; uncode_shortcode_id=&#8221;641621&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_single_image media=&#8221;160548&#8243; media_width_percent=&#8221;15&#8243; uncode_shortcode_id=&#8221;174205&#8243;][vc_custom_heading text_color=&#8221;color-xsdn&#8221; text_font=&#8221;font-136269&#8243; text_size=&#8221;h3&#8243; text_weight=&#8221;800&#8243; text_transform=&#8221;uppercase&#8221; text_space=&#8221;fontspace-111509&#8243; text_uppercase=&#8221;&#8221; text_align=&#8221;text-left&#8221; uncode_shortcode_id=&#8221;398425&#8243; text_color_type=&#8221;uncode-palette&#8221;]Computer system validation in accordance with GAMP 5, EU\/FDA GMP guidelines[\/vc_custom_heading][\/vc_column][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; back_color=&#8221;color-wvjs&#8221; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/6&#8243; uncode_shortcode_id=&#8221;679678&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_single_image media=&#8221;160549&#8243; media_width_percent=&#8221;15&#8243; uncode_shortcode_id=&#8221;176063&#8243;][vc_custom_heading text_color=&#8221;color-xsdn&#8221; heading_semantic=&#8221;h3&#8243; text_font=&#8221;font-136269&#8243; text_size=&#8221;h3&#8243; text_weight=&#8221;800&#8243; text_transform=&#8221;uppercase&#8221; text_space=&#8221;fontspace-111509&#8243; text_uppercase=&#8221;&#8221; text_align=&#8221;text-left&#8221; uncode_shortcode_id=&#8221;171216&#8243; text_color_type=&#8221;uncode-palette&#8221;]Data integrity strategies design to ensure the compliance of the GxP records to the ALCOA+ principles[\/vc_custom_heading][\/vc_column][\/vc_row][vc_row unlock_row_content=&#8221;yes&#8221; row_height_percent=&#8221;30&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;0&#8243; top_padding=&#8221;0&#8243; bottom_padding=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; equal_height=&#8221;yes&#8221; gutter_size=&#8221;0&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; 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