{"id":3022,"date":"2020-05-01T16:51:00","date_gmt":"2020-05-01T14:51:00","guid":{"rendered":"https:\/\/catuslaw.com\/blog\/compliance-management-folge-5-compliance-prozesse-den-rahmen-praezisieren\/"},"modified":"2022-02-28T11:09:56","modified_gmt":"2022-02-28T10:09:56","slug":"compliance-management-epsiode-5-compliance-processes-establishing-the-framework","status":"publish","type":"post","link":"https:\/\/catuslaw.com\/en\/blog\/compliance-management-epsiode-5-compliance-processes-establishing-the-framework\/","title":{"rendered":"Compliance Management Episode 5: Compliance Processes \u2013 Establishing the Framework"},"content":{"rendered":"\n<!-- Block-Wrapper Anfang -->\n<div id=\"header-1col-block_60d447d7f0b03\" class=\"block block--header-1col\" >\n  <div class=\" block__inner block__inner--header-1col \">\n<!-- \/Block-Wrapper Anfang -->\n\n    <div class=\"container\">\n      <div class=\"content row\">\n        <div class=\"col-12\">\n\n          \n\n  <div class=\"content__modul content__img content__img--quer\">\n    <img decoding=\"async\" src=\"https:\/\/catuslaw.com\/wp-content\/uploads\/2021\/06\/12-month-compliance-challange-5-aspect-ratio-3-2-1.jpg\">\n      <\/div>\n\n\n        <\/div>\n      <\/div>\n    <\/div>\n\n\n<!-- Block-Wrapper Ende -->\n  <\/div><!-- .block__inner -->\n<\/div><!-- .block -->\n<!-- \/Block-Wrapper Ende -->\n\n\n\n\n  <style type=\"text\/css\">\n    \/* H\u00f6he *\/\n    #header-1col-block_60d447d7f0b03 .block__inner--header-1col{\n              min-height: 50vh;\n          }\n\n    \n    \n    \n    \n    \n    \/* Hintergrundbild *\/\n    \n    \/* Navigationshintergrund und Verlauf *\/\n    \n    \/* Block-Einstellungen *\/\n    #header-1col-block_60d447d7f0b03{      background-color: #FFFFFF;          }                  <\/style>\n\n\n\n<!-- Block-Wrapper Anfang -->\n<div id=\"content-1col-block_60d4486ef0b05\" class=\"block block--content-1col pt-3 pb-0   \">\n  <div class=\"block__inner block__inner--content-1col container \">\n    <!-- \/Block-Wrapper Anfang -->\n\n        <div class=\"row\">\n                    <div class=\"col-12\">\n          \n          \n            \n<div class=\"content__modul content__text\">\n  <h2>Compliance Management<br \/>\nEpisode 5: Compliance Processes \u2013 Establishing the Framework<\/h2>\n<p>In episode 4 of this series, we saw that guidelines \u2013 often called \u201cpolicies\u201d \u2013 are the backbone of a CMS.<\/p>\n<\/div>\n\n          \n\n          <\/div>\n        <\/div>\n\n<!-- Block-Wrapper Ende -->\n      <\/div><!-- .block__inner -->\n<\/div><!-- .block -->\n<!-- \/Block-Wrapper Ende -->\n\n<script>\n\nvar kachelID = '#content-1col-block_60d4486ef0b05';\n\noneColSlider(kachelID);\n\nfunction oneColSlider(kachelID){\n\n  var kachelSelector = kachelID + ' .onecol-slider__inner';\n  var dotSelector = kachelID + ' .onecol-slider__dots';\n  var arrowsSelector = kachelID + ' .onecol-slider__arrows';\n\n  jQuery( document ).ready(function() {\n      jQuery(kachelSelector).slick({\n        dots: true,\n        appendDots: jQuery(dotSelector),\n        arrows: true,\n        appendArrows: jQuery(arrowsSelector),\n        prevArrow: '<i class=\"fas fa-arrow-alt-circle-left onecol-slider__arrows--prev\"><\/i>',\n        nextArrow: '<i class=\"fas fa-arrow-alt-circle-right onecol-slider__arrows--next\"><\/i>',\n        infinite: true,\n        speed: 500,\n        autoplay: true,\n        autoplaySpeed: 10000,\n        slidesToShow: 1\n\n      });\n    });\n\n}\n<\/script>\n\n\n  <style type=\"text\/css\">\n    #content-1col-block_60d4486ef0b05{      background-color: #FFFFFF;          }                  <\/style>\n\n\n\n<!-- Block-Wrapper Anfang -->\n<div id=\"content-1col-block_60d44955f0b07\" class=\"block block--content-1col pt-3 pb-0   \">\n  <div class=\"block__inner block__inner--content-1col container \">\n    <!-- \/Block-Wrapper Anfang -->\n\n        <div class=\"row\">\n                    <div class=\"col-12\">\n          \n          \n            \n<div class=\"content__modul content__text\">\n  <h3>What exactly are \u201cprocesses\u201d?<\/h3>\n<p>If guidelines provide necessary structure and mark the <strong>expectation horizon<\/strong>, processes transform business operations into a defined sequence of steps.<\/p>\n<p>In general, a distinction is made in <strong>business processes<\/strong> between leadership or management processes, the value-creating core processes directly related to the company\u2019s products or services, and <strong>supporting processes<\/strong>. The last category includes risk analysis processes and, therefore, compliance processes. Regardless of how detailed the process descriptions are, they should depict processes and tasks within the company as clearly as possible, and specify that they are binding.<\/p>\n<p><span class=\"marginalia\">Ideally, business processes \u2013 and thus compliance processes \u2013 should be described so that the reader understands how processes and tasks within the company are currently running (\u201cexisting processes\u201d) and how they should run (\u201ctarget processes\u201d).<\/span><\/p>\n<\/div>\n\n          \n\n          <\/div>\n        <\/div>\n\n<!-- Block-Wrapper Ende -->\n      <\/div><!-- .block__inner -->\n<\/div><!-- .block -->\n<!-- \/Block-Wrapper Ende -->\n\n<script>\n\nvar kachelID = '#content-1col-block_60d44955f0b07';\n\noneColSlider(kachelID);\n\nfunction oneColSlider(kachelID){\n\n  var kachelSelector = kachelID + ' .onecol-slider__inner';\n  var dotSelector = kachelID + ' .onecol-slider__dots';\n  var arrowsSelector = kachelID + ' .onecol-slider__arrows';\n\n  jQuery( document ).ready(function() {\n      jQuery(kachelSelector).slick({\n        dots: true,\n        appendDots: jQuery(dotSelector),\n        arrows: true,\n        appendArrows: jQuery(arrowsSelector),\n        prevArrow: '<i class=\"fas fa-arrow-alt-circle-left onecol-slider__arrows--prev\"><\/i>',\n        nextArrow: '<i class=\"fas fa-arrow-alt-circle-right onecol-slider__arrows--next\"><\/i>',\n        infinite: true,\n        speed: 500,\n        autoplay: true,\n        autoplaySpeed: 10000,\n        slidesToShow: 1\n\n      });\n    });\n\n}\n<\/script>\n\n\n  <style type=\"text\/css\">\n    #content-1col-block_60d44955f0b07{      background-color: #FFFFFF;          }                  <\/style>\n\n\n\n<!-- Block-Wrapper Anfang -->\n<div id=\"content-1col-block_60d4499df0b09\" class=\"block block--content-1col pt-3 pb-0   \">\n  <div class=\"block__inner block__inner--content-1col container \">\n    <!-- \/Block-Wrapper Anfang -->\n\n        <div class=\"row\">\n                    <div class=\"col-12\">\n          \n          \n            \n<div class=\"content__modul content__text\">\n  <h3>Describing Processes<\/h3>\n<p>Charts can often be useful in depicting processes. There are software programs (such as Visio or Lucidchart) that can help visualize processes, but for less complex processes PowerPoint shapes do the job, too.<\/p>\n<p>In any case, well-known and reliable systems should be used to create the visual. For years now, the Object Management Group Inc. (\u201cOMG\u201d) has been defining and standardizing the basic elements of process description and the procedure for process modelling (see <a href=\"https:\/\/www.omg.org\/\" target=\"_blank\" rel=\"noopener\">https:\/\/www.omg.org\/<\/a>).<\/p>\n<p>Standard Operating Procedures (SOPs) are a common way of implementing processes. SOPs generally describe the following (1) the aim and purpose of the process, (2) its application, (3) the process itself, (4) who is responsible for it, (5) how the process is documented, and (6) steps for monitoring the process, if applicable.<\/p>\n<\/div>\n\n          \n\n          <\/div>\n        <\/div>\n\n<!-- Block-Wrapper Ende -->\n      <\/div><!-- .block__inner -->\n<\/div><!-- .block -->\n<!-- \/Block-Wrapper Ende -->\n\n<script>\n\nvar kachelID = '#content-1col-block_60d4499df0b09';\n\noneColSlider(kachelID);\n\nfunction oneColSlider(kachelID){\n\n  var kachelSelector = kachelID + ' .onecol-slider__inner';\n  var dotSelector = kachelID + ' .onecol-slider__dots';\n  var arrowsSelector = kachelID + ' .onecol-slider__arrows';\n\n  jQuery( document ).ready(function() {\n      jQuery(kachelSelector).slick({\n        dots: true,\n        appendDots: jQuery(dotSelector),\n        arrows: true,\n        appendArrows: jQuery(arrowsSelector),\n        prevArrow: '<i class=\"fas fa-arrow-alt-circle-left onecol-slider__arrows--prev\"><\/i>',\n        nextArrow: '<i class=\"fas fa-arrow-alt-circle-right onecol-slider__arrows--next\"><\/i>',\n        infinite: true,\n        speed: 500,\n        autoplay: true,\n        autoplaySpeed: 10000,\n        slidesToShow: 1\n\n      });\n    });\n\n}\n<\/script>\n\n\n  <style type=\"text\/css\">\n    #content-1col-block_60d4499df0b09{      background-color: #FFFFFF;          }                  <\/style>\n\n\n\n<!-- Block-Wrapper Anfang -->\n<div id=\"content-1col-block_60d44e04f0b0c\" class=\"block block--content-1col pt-3 pb-0   \">\n  <div class=\"block__inner block__inner--content-1col container \">\n    <!-- \/Block-Wrapper Anfang -->\n\n        <div class=\"row\">\n                    <div class=\"col-12\">\n          \n          \n            \n<div class=\"content__modul content__text\">\n  <h3>Typical Regulations<\/h3>\n<p>Descriptions of compliance processes typically <strong>define roles and responsibilities<\/strong> which can be used to better manage and control especially critical (i.e. risky) activities.<\/p>\n<p>The implementation of compliance processes can be illustrated by the example of interactions between the pharmaceutical industry and healthcare professionals. <span class=\"marginalia\">During such activities (training events, speaking or consultancy contracts, sponsoring, donations, etc.) compliance must be ensured with all requirements of competition and anti-corruption laws and rules of industry codes.<\/span> A compliance officer will therefore carefully consider how he or she should approach this task (aside from standard approaches such as training and the preparation of contract templates) and pay particular attention to the following issues:<\/p>\n<ul>\n<li>Description of roles and responsibilities (who is responsible for preparing the necessary paperwork, including a complete and accurate description of the cooperation arrangements and the need for them)<\/li>\n<li>Regulation of the \u201cdual control principle\u201d and approval by the Compliance Officer<\/li>\n<li>Implementation the separation between medical\/scientific functions and marketing\/sales<\/li>\n<li>Evaluation of how services are provided<\/li>\n<li>Prerequisites for invoicing and payment as well as integration into order and payment processes<\/li>\n<li>Documentation requirements<\/li>\n<li>Implementation of control and review measures (\u201cMonitoring\u201d)<\/li>\n<\/ul>\n<\/div>\n\n          \n\n          <\/div>\n        <\/div>\n\n<!-- Block-Wrapper Ende -->\n      <\/div><!-- .block__inner -->\n<\/div><!-- .block -->\n<!-- \/Block-Wrapper Ende -->\n\n<script>\n\nvar kachelID = '#content-1col-block_60d44e04f0b0c';\n\noneColSlider(kachelID);\n\nfunction oneColSlider(kachelID){\n\n  var kachelSelector = kachelID + ' .onecol-slider__inner';\n  var dotSelector = kachelID + ' .onecol-slider__dots';\n  var arrowsSelector = kachelID + ' .onecol-slider__arrows';\n\n  jQuery( document ).ready(function() {\n      jQuery(kachelSelector).slick({\n        dots: true,\n        appendDots: jQuery(dotSelector),\n        arrows: true,\n        appendArrows: jQuery(arrowsSelector),\n        prevArrow: '<i class=\"fas fa-arrow-alt-circle-left onecol-slider__arrows--prev\"><\/i>',\n        nextArrow: '<i class=\"fas fa-arrow-alt-circle-right onecol-slider__arrows--next\"><\/i>',\n        infinite: true,\n        speed: 500,\n        autoplay: true,\n        autoplaySpeed: 10000,\n        slidesToShow: 1\n\n      });\n    });\n\n}\n<\/script>\n\n\n  <style type=\"text\/css\">\n    #content-1col-block_60d44e04f0b0c{      background-color: #FFFFFF;          }                  <\/style>\n\n\n\n<!-- Block-Wrapper Anfang -->\n<div id=\"content-1col-block_60d44e38f0b0e\" class=\"block block--content-1col pt-3 pb-0   \">\n  <div class=\"block__inner block__inner--content-1col container \">\n    <!-- \/Block-Wrapper Anfang -->\n\n        <div class=\"row\">\n                    <div class=\"col-12\">\n          \n          \n            \n<div class=\"content__modul content__text\">\n  <h3>An important reminder: Involve stakeholders early on!<\/h3>\n<p>When establishing processes, it is, as always, vital to involve as many relevant departments and players in the development as possible, for example in workshops using the brown paper method.<\/p>\n<\/div>\n\n          \n\n          <\/div>\n        <\/div>\n\n<!-- Block-Wrapper Ende -->\n      <\/div><!-- .block__inner -->\n<\/div><!-- .block -->\n<!-- \/Block-Wrapper Ende -->\n\n<script>\n\nvar kachelID = '#content-1col-block_60d44e38f0b0e';\n\noneColSlider(kachelID);\n\nfunction oneColSlider(kachelID){\n\n  var kachelSelector = kachelID + ' .onecol-slider__inner';\n  var dotSelector = kachelID + ' .onecol-slider__dots';\n  var arrowsSelector = kachelID + ' .onecol-slider__arrows';\n\n  jQuery( document ).ready(function() {\n      jQuery(kachelSelector).slick({\n        dots: true,\n        appendDots: jQuery(dotSelector),\n        arrows: true,\n        appendArrows: jQuery(arrowsSelector),\n        prevArrow: '<i class=\"fas fa-arrow-alt-circle-left onecol-slider__arrows--prev\"><\/i>',\n        nextArrow: '<i class=\"fas fa-arrow-alt-circle-right onecol-slider__arrows--next\"><\/i>',\n        infinite: true,\n        speed: 500,\n        autoplay: true,\n        autoplaySpeed: 10000,\n        slidesToShow: 1\n\n      });\n    });\n\n}\n<\/script>\n\n\n  <style type=\"text\/css\">\n    #content-1col-block_60d44e38f0b0e{      background-color: #FFFFFF;          }                  <\/style>\n\n\n\n<!-- Block-Wrapper Anfang -->\n<div id=\"content-1col-block_60d44e4ef0b10\" class=\"block block--content-1col pt-3 pb-0   \">\n  <div class=\"block__inner block__inner--content-1col container \">\n    <!-- \/Block-Wrapper Anfang -->\n\n        <div class=\"row\">\n                    <div class=\"col-12\">\n          \n          \n            \n<div class=\"content__modul content__text\">\n  <h3>Training and Communication<\/h3>\n<p>As with guidelines, systematic communication and training is essential to the implementation of compliance processes. In addition, make sure that you <strong>regularly adapt<\/strong> your processes and keep careful track of <strong>versions<\/strong> (V 1.0, V 1.1, etc.), so that you always understand the big picture!<\/p>\n<\/div>\n\n          \n\n          <\/div>\n        <\/div>\n\n<!-- Block-Wrapper Ende -->\n      <\/div><!-- .block__inner -->\n<\/div><!-- .block -->\n<!-- \/Block-Wrapper Ende -->\n\n<script>\n\nvar kachelID = '#content-1col-block_60d44e4ef0b10';\n\noneColSlider(kachelID);\n\nfunction oneColSlider(kachelID){\n\n  var kachelSelector = kachelID + ' .onecol-slider__inner';\n  var dotSelector = kachelID + ' .onecol-slider__dots';\n  var arrowsSelector = kachelID + ' .onecol-slider__arrows';\n\n  jQuery( document ).ready(function() {\n      jQuery(kachelSelector).slick({\n        dots: true,\n        appendDots: jQuery(dotSelector),\n        arrows: true,\n        appendArrows: jQuery(arrowsSelector),\n        prevArrow: '<i class=\"fas fa-arrow-alt-circle-left onecol-slider__arrows--prev\"><\/i>',\n        nextArrow: '<i class=\"fas fa-arrow-alt-circle-right onecol-slider__arrows--next\"><\/i>',\n        infinite: true,\n        speed: 500,\n        autoplay: true,\n        autoplaySpeed: 10000,\n        slidesToShow: 1\n\n      });\n    });\n\n}\n<\/script>\n\n\n  <style type=\"text\/css\">\n    #content-1col-block_60d44e4ef0b10{      background-color: #FFFFFF;          }                  <\/style>\n\n\n\n<!-- Block-Wrapper Anfang -->\n<div id=\"content-1col-block_60d44e7ef0b12\" class=\"block block--content-1col pt-3 pb-3   \">\n  <div class=\"block__inner block__inner--content-1col container \">\n    <!-- \/Block-Wrapper Anfang -->\n\n        <div class=\"row\">\n                    <div class=\"col-12\">\n          \n          \n            \n<div class=\"content__modul content__text\">\n  <h3>What\u2019s Next:<\/h3>\n<p>In the next episode, we\u2019ll address<a href=\"https:\/\/catuslaw.com\/en\/blog\/compliance-management-episode-6-managements-commitment-and-obligations\/\"> compliance procedures<\/a>.<\/p>\n<p><strong>If you are unsure how to set up and run your compliance project successfully, please feel free to <a href=\"mailto:info@catuslaw.com\">contact<\/a> me.<\/strong><\/p>\n<\/div>\n\n          \n\n          <\/div>\n        <\/div>\n\n<!-- Block-Wrapper Ende -->\n      <\/div><!-- .block__inner -->\n<\/div><!-- .block -->\n<!-- \/Block-Wrapper Ende -->\n\n<script>\n\nvar kachelID = '#content-1col-block_60d44e7ef0b12';\n\noneColSlider(kachelID);\n\nfunction oneColSlider(kachelID){\n\n  var kachelSelector = kachelID + ' .onecol-slider__inner';\n  var dotSelector = kachelID + ' .onecol-slider__dots';\n  var arrowsSelector = kachelID + ' .onecol-slider__arrows';\n\n  jQuery( document ).ready(function() {\n      jQuery(kachelSelector).slick({\n        dots: true,\n        appendDots: jQuery(dotSelector),\n        arrows: true,\n        appendArrows: jQuery(arrowsSelector),\n        prevArrow: '<i class=\"fas fa-arrow-alt-circle-left onecol-slider__arrows--prev\"><\/i>',\n        nextArrow: '<i class=\"fas fa-arrow-alt-circle-right onecol-slider__arrows--next\"><\/i>',\n        infinite: true,\n        speed: 500,\n        autoplay: true,\n        autoplaySpeed: 10000,\n        slidesToShow: 1\n\n      });\n    });\n\n}\n<\/script>\n\n\n  <style type=\"text\/css\">\n    #content-1col-block_60d44e7ef0b12{      background-color: #FFFFFF;          }                  <\/style>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[4],"tags":[],"class_list":["post-3022","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Compliance Processes &#8211;Compliance Management Episode 5 &#8211; Catus Blog<\/title>\n<meta name=\"description\" content=\"As with guidelines, systematic communication and training is essential to the implementation of compliance processes.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/catuslaw.com\/en\/blog\/compliance-management-epsiode-5-compliance-processes-establishing-the-framework\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Compliance Processes &#8211;Compliance Management Episode 5 &#8211; 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