{"id":6261,"date":"2026-06-23T16:35:14","date_gmt":"2026-06-23T14:35:14","guid":{"rendered":"https:\/\/gmpca.ch\/beratung\/"},"modified":"2026-08-06T16:13:12","modified_gmt":"2026-08-06T14:13:12","slug":"beratung","status":"publish","type":"page","link":"https:\/\/gmpca.ch\/en\/beratung\/","title":{"rendered":"Expertise"},"content":{"rendered":"\t<section id=\"res-nav-tab-block_1506814cd3260e96bec20e90c2032f56\" class=\"res-block res-navtab style-standard layout02 pb-4  Transparent   sticky-subnav \" style=\"background: transparent;\">\r\n\t\t<div class=\"inner-container container-small\" data-aos=\"res-fadeIn\">\r\n\r\n\t\t\t\r\n\t\t\t\t\t\t\r\n\t\t\t\t\t\t\r\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"tabs tabs-acf\">\r\n\t\t\t\t\t\t\t\t<div class=\"tabsNav tab-links\">\r\n\t\t\t\t\t\t\t\t\t<ul class=\"nav nav-pills nav-fill nav-quer\">\r\n\t\t\t\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t\t\t\t\t\t\t\t<li class=\"nav-single-tab nav-item  \">\r\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"nav-link scrollerTo\"href=\"#inspection\" target=\"_parent\"><span>Inspection &#038; Regulatory<\/span><\/a>\r\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/li>\r\n\t\t\t\t\t\t\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t\t\t\t\t\t\t\t<li class=\"nav-single-tab nav-item  \">\r\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"nav-link scrollerTo\"href=\"#validation\" target=\"_parent\"><span>Validation &amp; Process<\/span><\/a>\r\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/li>\r\n\t\t\t\t\t\t\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t\t\t\t\t\t\t\t<li class=\"nav-single-tab nav-item  \">\r\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"nav-link scrollerTo\"href=\"#datenintegritaet\" target=\"_parent\"><span>Data Integrity &amp; Digial Systems<\/span><\/a>\r\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/li>\r\n\t\t\t\t\t\t\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t\t\t\t\t\t\t\t<li class=\"nav-single-tab nav-item  \">\r\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"nav-link scrollerTo\"href=\"#engineering\" target=\"_parent\"><span>Engineering &amp; GMP Projects<\/span><\/a>\r\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/li>\r\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\r\n\t\t\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t\t\r\n\t\t\t\t\r\n\t\t<\/div>\r\n\t<\/section>\r\n\r\n\n\n\r\n\r\n\r\n<section id=\"res-txt-block_13c67ace8f238e90c55ba53b66607faa\" class=\"res-block res-txt style-standard layout01 pb-3  Transparent \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off headline-title\" data-aos=\"res-topIncomingMore\">\r\n \r\n\t\t  \r\n\t\t \t  \r\n      \r\n      <div class=\"layout-1 txt-section text-left\">\r\n\t\t<div class=\"row layout-1-center \">\t\r\n\t\t\t\r\n\t\t\t\t\t<div class=\"col-md-8 var-1spalten \">\r\n\t\t\t\t\r\n\t\t\t\t<div class=\"txt-title-field\">\r\n\t\t\t\t\t\r\n\t\t\t\t\t\t\r\n\t\r\n\t\t\t\t\t\t\t\t   <h1 class=\"title-h1 \">Expertise for GMP Systems and Projects<\/h1>\r\n\t\t\t\t\t\r\n\t\t\r\n\t\t\t\t\r\n\t\t\t\t\t\r\n\t\t\t\t\t \r\n\t\t\t\t\t<\/div>\r\n\r\n\t\t\t\t\r\n                \r\n\t\t\t\t\t            <\/div>\r\n\t\t\t\t <\/div> \t\r\n\t\t<\/div>\r\n\t \r\n\r\n     \r\n\t<\/div>\r\n<\/section>\r\n\r\n\n\n\r\n  \r\n\t<style>\r\n\t\t#res-link-anker-block_6530e05237684f7736316c1073b2f289 .link-anker-with-no-padding {padding: 0 !important;}\r\n  <\/style> \r\n\r\n\r\n\r\n\r\n\r\n<section id=\"res-link-anker-block_6530e05237684f7736316c1073b2f289\" class=\"linkanker-section\">\r\n<div  id=\"inspection\"  class=\"res-block res-link-anker style-standard py-4  Transparent link-anker-with-no-padding \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off\" data-aos=\"res-fadeIn\">\r\n\t\r\n\t\t\r\n  \r\n\r\n\t<\/div>\r\n  <\/div>\r\n<\/section>\n\n\r\n\r\n\r\n<section id=\"res-txt-block_77eeb782ce7e2d68a57f82ea9b2b9194\" class=\"res-block res-txt style-02 layout01 py-2  Transparent \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off \" data-aos=\"res-topIncoming\">\r\n \r\n\t\t  \r\n\t\t \t  \r\n      \r\n      <div class=\"layout-1 txt-section text-left\">\r\n\t\t<div class=\"row layout-1-center \">\t\r\n\t\t\t\r\n\t\t\t\t\t<div class=\"col-md-10 var-1spalten \">\r\n\t\t\t\t\r\n\t\t\t\t<div class=\"txt-title-field\">\r\n\t\t\t\t\t\r\n\t\t\t\t\t\t\r\n\t\r\n\t\t\t\t\t\r\n\t\t\r\n\t\t\t\t  \r\n\t\t\t\t   <h2 class=\"title-h2 \">Inspection &amp; Regulatory<\/h2>\r\n\t\t\t\t\r\n\t\t\t\t \r\n\t\t\t\t   <h3 class=\"title-h3 \">Regulatory Readiness and Inspection Preparation<br \/>\r\n<\/h3>\r\n\t\t\t\t\t\r\n\t\t\t\t\t \r\n\t\t\t\t\t<\/div>\r\n\r\n\t\t\t\t\r\n                \r\n\t\t\t\t\t            <\/div>\r\n\t\t\t\t <\/div> \t\r\n\t\t<\/div>\r\n\t \r\n\r\n     \r\n\t<\/div>\r\n<\/section>\r\n\r\n\n\n\r\n \r\n\r\n\r\n\r\n\r\n<section id=\"res-link-anker-block_cc20986661d7556eda41ff362feddd52\" class=\"linkanker-section\">\r\n<div  class=\"res-block res-link-anker style-standard py-1  Transparent  \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off\" data-aos=\"res-downIncoming\">\r\n\t\r\n\t\t<hr  >\r\n\t\t\r\n  \r\n\r\n\t<\/div>\r\n  <\/div>\r\n<\/section>\n\n\r\n\r\n\r\n<section id=\"res-txt-block_262504d02261b9d67f74f8db7f17d9da\" class=\"res-block res-txt style-standard layout02 py-1  Transparent \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off \" data-aos=\"res-downIncoming\">\r\n \r\n\t\t  \r\n\t\t  <style>\r\n\t\t @media only screen and (min-width: 970px) {\r\n\t\t  #res-txt-block_262504d02261b9d67f74f8db7f17d9da.res-txt .layout-2 .spalten-abstand { margin-right: 18%;}\r\n\t  <\/style>\r\n\t      \r\n    <div class=\"layout-2 txt-editor-spalten\">\r\n     <div class=\"row row-cols-1 row-cols-md- no-gutters\">\r\n\t \r\n\t\t \r\n        <!--   Spaltentext Loop Row  -->\r\n                                   <div class=\"col\">\r\n                     <div class=\"postContent\">\r\n\r\n                    <!--  Spalten Repeater  -->\r\n                                           \r\n                      <div class=\"row text-spalten-Box no-gutters \"> \r\n\r\n                            <div class=\"col-md-5 text-spalten-spalte01 \">\r\n                                <div class=\"spalten-abstand\">\r\n                                <h3>QMS Design and Review<\/h3>\n<p>Design and review of quality management systems to ensure regulatory readiness and effective governance<\/p>\n                                <\/div>     \r\n                            <\/div>\r\n\r\n                            <div class=\"col-md text-spalten-spalte02 \">\r\n                              <h4>Focus:<\/h4>\n<ul>\n<li>Design and structuring of the QMS framework<\/li>\n<li>Definition of GMP-relevant processes and governance<\/li>\n<li>Gap analysis between existing quality systems and GMP requirements<\/li>\n<li>Review of management oversight and escalation mechanisms<\/li>\n<li>Alignment of company-wide quality structures with GMP expectations<\/li>\n<\/ul>\n                            <\/div>\r\n\r\n                      <\/div>\t\t\t\r\n\r\n                                           \r\n                    <\/div>\r\n                 <\/div>\r\n\r\n                                    <\/div> \r\n        <\/div>  \r\n\t \r\n\r\n     \r\n\t<\/div>\r\n<\/section>\r\n\r\n\n\n\r\n \r\n\r\n\r\n\r\n\r\n<section id=\"res-link-anker-block_cc20986661d7556eda41ff362feddd52\" class=\"linkanker-section\">\r\n<div  class=\"res-block res-link-anker style-standard py-1  Transparent  \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off\" data-aos=\"res-downIncoming\">\r\n\t\r\n\t\t<hr  >\r\n\t\t\r\n  \r\n\r\n\t<\/div>\r\n  <\/div>\r\n<\/section>\n\n\r\n\r\n\r\n<section id=\"res-txt-block_9474a9b83adfeaec35957e3ca8e4b9ef\" class=\"res-block res-txt style-standard layout02 py-1  Transparent \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off \" data-aos=\"res-downIncoming\">\r\n \r\n\t\t  \r\n\t\t  <style>\r\n\t\t @media only screen and (min-width: 970px) {\r\n\t\t  #res-txt-block_9474a9b83adfeaec35957e3ca8e4b9ef.res-txt .layout-2 .spalten-abstand { margin-right: 18%;}\r\n\t  <\/style>\r\n\t      \r\n    <div class=\"layout-2 txt-editor-spalten\">\r\n     <div class=\"row row-cols-1 row-cols-md- no-gutters\">\r\n\t \r\n\t\t \r\n        <!--   Spaltentext Loop Row  -->\r\n                                   <div class=\"col\">\r\n                     <div class=\"postContent\">\r\n\r\n                    <!--  Spalten Repeater  -->\r\n                                           \r\n                      <div class=\"row text-spalten-Box no-gutters \"> \r\n\r\n                            <div class=\"col-md-5 text-spalten-spalte01 \">\r\n                                <div class=\"spalten-abstand\">\r\n                                <h3>GMP Gap Analysis<\/h3>\n<p>Structured identification of GMP gaps, regulatory risks and systemic weaknesses<\/p>\n                                <\/div>     \r\n                            <\/div>\r\n\r\n                            <div class=\"col-md text-spalten-spalte02 \">\r\n                              <h4>Focus:<\/h4>\n<ul>\n<li>Holistic review of GMP systems and control structures<\/li>\n<li>Maturity assessment of regulatory governance<\/li>\n<li>Differentiation between systemic weaknesses and isolated deficiencies<\/li>\n<li>Cross-functional analysis of compliance gaps<\/li>\n<li>Development of a prioritised action plan at management level<\/li>\n<\/ul>\n                            <\/div>\r\n\r\n                      <\/div>\t\t\t\r\n\r\n                                           \r\n                    <\/div>\r\n                 <\/div>\r\n\r\n                                    <\/div> \r\n        <\/div>  \r\n\t \r\n\r\n     \r\n\t<\/div>\r\n<\/section>\r\n\r\n\n\n\r\n \r\n\r\n\r\n\r\n\r\n<section id=\"res-link-anker-block_cc20986661d7556eda41ff362feddd52\" class=\"linkanker-section\">\r\n<div  class=\"res-block res-link-anker style-standard py-1  Transparent  \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off\" data-aos=\"res-downIncoming\">\r\n\t\r\n\t\t<hr  >\r\n\t\t\r\n  \r\n\r\n\t<\/div>\r\n  <\/div>\r\n<\/section>\n\n\r\n\r\n\r\n<section id=\"res-txt-block_53af107b69c6b9b02e35d2b2460c342d\" class=\"res-block res-txt style-standard layout02 py-1  Transparent \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off \" data-aos=\"res-downIncoming\">\r\n \r\n\t\t  \r\n\t\t  <style>\r\n\t\t @media only screen and (min-width: 970px) {\r\n\t\t  #res-txt-block_53af107b69c6b9b02e35d2b2460c342d.res-txt .layout-2 .spalten-abstand { margin-right: 18%;}\r\n\t  <\/style>\r\n\t      \r\n    <div class=\"layout-2 txt-editor-spalten\">\r\n     <div class=\"row row-cols-1 row-cols-md- no-gutters\">\r\n\t \r\n\t\t \r\n        <!--   Spaltentext Loop Row  -->\r\n                                   <div class=\"col\">\r\n                     <div class=\"postContent\">\r\n\r\n                    <!--  Spalten Repeater  -->\r\n                                           \r\n                      <div class=\"row text-spalten-Box no-gutters \"> \r\n\r\n                            <div class=\"col-md-5 text-spalten-spalte01 \">\r\n                                <div class=\"spalten-abstand\">\r\n                                <h3>Regulatory Readiness Assessment<\/h3>\n<p>Cross-system evaluation of GMP-relevant systems and interfaces<\/p>\n                                <\/div>     \r\n                            <\/div>\r\n\r\n                            <div class=\"col-md text-spalten-spalte02 \">\r\n                              <h4>Focus:<\/h4>\n<ul>\n<li data-section-id=\"18z58fw\" data-start=\"329\" data-end=\"405\">Assessment of change control, deviation management and CAPA governance<\/li>\n<li data-section-id=\"nn88te\" data-start=\"406\" data-end=\"477\">Assessment of risk management maturity and compliance with ICH Q9<\/li>\n<li data-section-id=\"fynlym\" data-start=\"478\" data-end=\"545\">Review of cross-functional interfaces and escalation pathways<\/li>\n<li data-section-id=\"6aljvd\" data-start=\"546\" data-end=\"627\">Assessment of findings and early indicators of quality and compliance risks<\/li>\n<li data-section-id=\"c4ocg8\" data-start=\"628\" data-end=\"698\">Stress testing of procedural consistency in operational practice<\/li>\n<\/ul>\n                            <\/div>\r\n\r\n                      <\/div>\t\t\t\r\n\r\n                                           \r\n                    <\/div>\r\n                 <\/div>\r\n\r\n                                    <\/div> \r\n        <\/div>  \r\n\t \r\n\r\n     \r\n\t<\/div>\r\n<\/section>\r\n\r\n\n\n\r\n \r\n\r\n\r\n\r\n\r\n<section id=\"res-link-anker-block_cc20986661d7556eda41ff362feddd52\" class=\"linkanker-section\">\r\n<div  class=\"res-block res-link-anker style-standard py-1  Transparent  \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off\" data-aos=\"res-downIncoming\">\r\n\t\r\n\t\t<hr  >\r\n\t\t\r\n  \r\n\r\n\t<\/div>\r\n  <\/div>\r\n<\/section>\n\n\r\n\r\n\r\n<section id=\"res-txt-block_a66a9afd77b726dec6f404f6d62872f6\" class=\"res-block res-txt style-standard layout02 py-1  Transparent \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off \" data-aos=\"res-downIncoming\">\r\n \r\n\t\t  \r\n\t\t  <style>\r\n\t\t @media only screen and (min-width: 970px) {\r\n\t\t  #res-txt-block_a66a9afd77b726dec6f404f6d62872f6.res-txt .layout-2 .spalten-abstand { margin-right: 17%;}\r\n\t  <\/style>\r\n\t      \r\n    <div class=\"layout-2 txt-editor-spalten\">\r\n     <div class=\"row row-cols-1 row-cols-md- no-gutters\">\r\n\t \r\n\t\t \r\n        <!--   Spaltentext Loop Row  -->\r\n                                   <div class=\"col\">\r\n                     <div class=\"postContent\">\r\n\r\n                    <!--  Spalten Repeater  -->\r\n                                           \r\n                      <div class=\"row text-spalten-Box no-gutters \"> \r\n\r\n                            <div class=\"col-md-5 text-spalten-spalte01 \">\r\n                                <div class=\"spalten-abstand\">\r\n                                <h3>Annex 1 and Contamination Control Readiness<\/h3>\n<p>Alignment of governance with Annex 1 requirements and contamination control principles<\/p>\n                                <\/div>     \r\n                            <\/div>\r\n\r\n                            <div class=\"col-md text-spalten-spalte02 \">\r\n                              <h4>Focus:<\/h4>\n<ul>\n<li data-section-id=\"fpqp4u\" data-start=\"1001\" data-end=\"1084\">Maturity and lifecycle governance of the Contamination Control Strategy (CCS)<\/li>\n<li data-section-id=\"1m1o13p\" data-start=\"1085\" data-end=\"1165\">Integration of environmental monitoring, utilities and validation controls<\/li>\n<li data-section-id=\"1k7cerf\" data-start=\"1166\" data-end=\"1219\">Accountability structures for sterile processes<\/li>\n<li data-section-id=\"y5szge\" data-start=\"1220\" data-end=\"1270\">Integration into management review processes<\/li>\n<li data-section-id=\"1jsjdrx\" data-start=\"1271\" data-end=\"1329\">Cross-functional escalation and oversight mechanisms<\/li>\n<\/ul>\n                            <\/div>\r\n\r\n                      <\/div>\t\t\t\r\n\r\n                                           \r\n                    <\/div>\r\n                 <\/div>\r\n\r\n                                    <\/div> \r\n        <\/div>  \r\n\t \r\n\r\n     \r\n\t<\/div>\r\n<\/section>\r\n\r\n\n\n\r\n \r\n\r\n\r\n\r\n\r\n<section id=\"res-link-anker-block_cc20986661d7556eda41ff362feddd52\" class=\"linkanker-section\">\r\n<div  class=\"res-block res-link-anker style-standard py-1  Transparent  \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off\" data-aos=\"res-downIncoming\">\r\n\t\r\n\t\t<hr  >\r\n\t\t\r\n  \r\n\r\n\t<\/div>\r\n  <\/div>\r\n<\/section>\n\n\r\n\r\n\r\n<section id=\"res-txt-block_a9a3ccb68162817c6a665ccf46622182\" class=\"res-block res-txt style-standard layout02 py-1  Transparent \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off \" data-aos=\"res-downIncoming\">\r\n \r\n\t\t  \r\n\t\t  <style>\r\n\t\t @media only screen and (min-width: 970px) {\r\n\t\t  #res-txt-block_a9a3ccb68162817c6a665ccf46622182.res-txt .layout-2 .spalten-abstand { margin-right: 18%;}\r\n\t  <\/style>\r\n\t      \r\n    <div class=\"layout-2 txt-editor-spalten\">\r\n     <div class=\"row row-cols-1 row-cols-md- no-gutters\">\r\n\t \r\n\t\t \r\n        <!--   Spaltentext Loop Row  -->\r\n                                   <div class=\"col\">\r\n                     <div class=\"postContent\">\r\n\r\n                    <!--  Spalten Repeater  -->\r\n                                           \r\n                      <div class=\"row text-spalten-Box no-gutters \"> \r\n\r\n                            <div class=\"col-md-5 text-spalten-spalte01 \">\r\n                                <div class=\"spalten-abstand\">\r\n                                <h3>Audit and Inspection Support<\/h3>\n<p>Structured preparation for regulatory inspections and audits<\/p>\n                                <\/div>     \r\n                            <\/div>\r\n\r\n                            <div class=\"col-md text-spalten-spalte02 \">\r\n                              <h4>Focus:<\/h4>\n<ul>\n<li data-section-id=\"1la6gyh\" data-start=\"236\" data-end=\"279\">Simulated inspections at system level<\/li>\n<li data-section-id=\"1ld102x\" data-start=\"280\" data-end=\"340\">Assessment of inspection readiness at management level<\/li>\n<li data-section-id=\"m47a99\" data-start=\"341\" data-end=\"395\">Development of a consistent inspection narrative<\/li>\n<li data-section-id=\"1jvmfhg\" data-start=\"396\" data-end=\"439\">Review of critical quality trend data<\/li>\n<li data-section-id=\"gqxdxk\" data-start=\"440\" data-end=\"494\">Simulation of interview and escalation scenarios<\/li>\n<\/ul>\n                            <\/div>\r\n\r\n                      <\/div>\t\t\t\r\n\r\n                                           \r\n                    <\/div>\r\n                 <\/div>\r\n\r\n                                    <\/div> \r\n        <\/div>  \r\n\t \r\n\r\n     \r\n\t<\/div>\r\n<\/section>\r\n\r\n\n\n\r\n \r\n\r\n\r\n\r\n\r\n<section id=\"res-link-anker-block_cc20986661d7556eda41ff362feddd52\" class=\"linkanker-section\">\r\n<div  class=\"res-block res-link-anker style-standard py-1  Transparent  \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off\" data-aos=\"res-downIncoming\">\r\n\t\r\n\t\t<hr  >\r\n\t\t\r\n  \r\n\r\n\t<\/div>\r\n  <\/div>\r\n<\/section>\n\n\r\n \r\n\r\n\r\n\r\n\r\n<section id=\"res-link-anker-block_a64d805b3e73d43e558137649732054d\" class=\"linkanker-section\">\r\n<div  class=\"res-block res-link-anker style-standard pt-5  Transparent  \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off\" data-aos=\"res-fadeIn\">\r\n\t\r\n\t\t\r\n  \r\n\r\n\t<\/div>\r\n  <\/div>\r\n<\/section>\n\n\r\n \r\n\r\n\r\n\r\n\r\n<section id=\"res-link-anker-block_51dd77cc2d7bd57ff5abcbe9bd3cc66f\" class=\"linkanker-section\">\r\n<div  id=\"validation\"  class=\"res-block res-link-anker style-standard pt-1  Transparent  \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off\" data-aos=\"res-fadeIn\">\r\n\t\r\n\t\t\r\n  \r\n\r\n\t<\/div>\r\n  <\/div>\r\n<\/section>\n\n\r\n\r\n\r\n<section id=\"res-txt-block_d29e0d63fe21894432f341f6bc2b976c\" class=\"res-block res-txt style-02 layout01 py-2  Transparent \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off \" data-aos=\"res-topIncoming\">\r\n \r\n\t\t  \r\n\t\t \t  \r\n      \r\n      <div class=\"layout-1 txt-section text-left\">\r\n\t\t<div class=\"row layout-1-center \">\t\r\n\t\t\t\r\n\t\t\t\t\t<div class=\"col-md-10 var-1spalten \">\r\n\t\t\t\t\r\n\t\t\t\t<div class=\"txt-title-field\">\r\n\t\t\t\t\t\r\n\t\t\t\t\t\t\r\n\t\r\n\t\t\t\t\t\r\n\t\t\r\n\t\t\t\t  \r\n\t\t\t\t   <h2 class=\"title-h2 \">Validation &amp; Process<\/h2>\r\n\t\t\t\t\r\n\t\t\t\t \r\n\t\t\t\t   <h3 class=\"title-h3 \">Validation Readiness, Lifecycle Management and Process Robustness<\/h3>\r\n\t\t\t\t\t\r\n\t\t\t\t\t \r\n\t\t\t\t\t<\/div>\r\n\r\n\t\t\t\t\r\n                \r\n\t\t\t\t\t            <\/div>\r\n\t\t\t\t <\/div> \t\r\n\t\t<\/div>\r\n\t \r\n\r\n     \r\n\t<\/div>\r\n<\/section>\r\n\r\n\n\n\r\n \r\n\r\n\r\n\r\n\r\n<section id=\"res-link-anker-block_cc20986661d7556eda41ff362feddd52\" class=\"linkanker-section\">\r\n<div  class=\"res-block res-link-anker style-standard py-1  Transparent  \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off\" data-aos=\"res-downIncoming\">\r\n\t\r\n\t\t<hr  >\r\n\t\t\r\n  \r\n\r\n\t<\/div>\r\n  <\/div>\r\n<\/section>\n\n\r\n\r\n\r\n<section id=\"res-txt-block_145956ddb394887f39d7c3c755a110f2\" class=\"res-block res-txt style-standard layout02 py-1  Transparent \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off \" data-aos=\"res-downIncoming\">\r\n \r\n\t\t  \r\n\t\t  <style>\r\n\t\t @media only screen and (min-width: 970px) {\r\n\t\t  #res-txt-block_145956ddb394887f39d7c3c755a110f2.res-txt .layout-2 .spalten-abstand { margin-right: 17%;}\r\n\t  <\/style>\r\n\t      \r\n    <div class=\"layout-2 txt-editor-spalten\">\r\n     <div class=\"row row-cols-1 row-cols-md- no-gutters\">\r\n\t \r\n\t\t \r\n        <!--   Spaltentext Loop Row  -->\r\n                                   <div class=\"col\">\r\n                     <div class=\"postContent\">\r\n\r\n                    <!--  Spalten Repeater  -->\r\n                                           \r\n                      <div class=\"row text-spalten-Box no-gutters \"> \r\n\r\n                            <div class=\"col-md-5 text-spalten-spalte01 \">\r\n                                <div class=\"spalten-abstand\">\r\n                                <h3>Validation Strategy and Risk Framework<\/h3>\n<p>Structured definition of validation priorities, risk logic and control principles<\/p>\n                                <\/div>     \r\n                            <\/div>\r\n\r\n                            <div class=\"col-md text-spalten-spalte02 \">\r\n                              <h4>Focus:<\/h4>\n<ul>\n<li data-section-id=\"104kbiw\" data-start=\"236\" data-end=\"323\">Alignment of the validation strategy with product, process and system criticality<\/li>\n<li data-section-id=\"it45ig\" data-start=\"324\" data-end=\"398\">Risk-based prioritisation of qualification and validation activities<\/li>\n<li data-section-id=\"1xhzxm7\" data-start=\"399\" data-end=\"474\">Alignment of the validation scope with GMP and lifecycle requirements<\/li>\n<li data-section-id=\"3psu57\" data-start=\"475\" data-end=\"555\">Integration of process understanding, control strategy and risk management<\/li>\n<li data-section-id=\"g70w89\" data-start=\"556\" data-end=\"622\">Framework for consistent validation and escalation decisions<\/li>\n<\/ul>\n                            <\/div>\r\n\r\n                      <\/div>\t\t\t\r\n\r\n                                           \r\n                    <\/div>\r\n                 <\/div>\r\n\r\n                                    <\/div> \r\n        <\/div>  \r\n\t \r\n\r\n     \r\n\t<\/div>\r\n<\/section>\r\n\r\n\n\n\r\n \r\n\r\n\r\n\r\n\r\n<section id=\"res-link-anker-block_cc20986661d7556eda41ff362feddd52\" class=\"linkanker-section\">\r\n<div  class=\"res-block res-link-anker style-standard py-1  Transparent  \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off\" data-aos=\"res-downIncoming\">\r\n\t\r\n\t\t<hr  >\r\n\t\t\r\n  \r\n\r\n\t<\/div>\r\n  <\/div>\r\n<\/section>\n\n\r\n\r\n\r\n<section id=\"res-txt-block_dda846c939606c9697a2189f7e330adf\" class=\"res-block res-txt style-standard layout02 py-1  Transparent \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off \" data-aos=\"res-downIncoming\">\r\n \r\n\t\t  \r\n\t\t  <style>\r\n\t\t @media only screen and (min-width: 970px) {\r\n\t\t  #res-txt-block_dda846c939606c9697a2189f7e330adf.res-txt .layout-2 .spalten-abstand { margin-right: 18%;}\r\n\t  <\/style>\r\n\t      \r\n    <div class=\"layout-2 txt-editor-spalten\">\r\n     <div class=\"row row-cols-1 row-cols-md- no-gutters\">\r\n\t \r\n\t\t \r\n        <!--   Spaltentext Loop Row  -->\r\n                                   <div class=\"col\">\r\n                     <div class=\"postContent\">\r\n\r\n                    <!--  Spalten Repeater  -->\r\n                                           \r\n                      <div class=\"row text-spalten-Box no-gutters \"> \r\n\r\n                            <div class=\"col-md-5 text-spalten-spalte01 \">\r\n                                <div class=\"spalten-abstand\">\r\n                                <h3>Validation Programmes and Master Plans<\/h3>\n<p>Development of an integrated validation planning framework for implementation and oversight<\/p>\n                                <\/div>     \r\n                            <\/div>\r\n\r\n                            <div class=\"col-md text-spalten-spalte02 \">\r\n                              <h4>Focus:<\/h4>\n<ul>\n<li>Structuring the scope of validation, sequencing and responsibilities<\/li>\n<li>Aligning validation plans with project milestones and operational readiness<\/li>\n<li>Integration of equipment, utilities, facilities, processes and computer systems<\/li>\n<li>Planning logic for resource requirements, interfaces and execution dependencies<\/li>\n<li>Foundation for coordinated validation oversight and management reporting<\/li>\n<\/ul>\n                            <\/div>\r\n\r\n                      <\/div>\t\t\t\r\n\r\n                                           \r\n                    <\/div>\r\n                 <\/div>\r\n\r\n                                    <\/div> \r\n        <\/div>  \r\n\t \r\n\r\n     \r\n\t<\/div>\r\n<\/section>\r\n\r\n\n\n\r\n\r\n\r\n<section id=\"res-txt-block_95f72998a0c50621fd01df9f593cb504\" class=\"res-block res-txt style-standard layout02 py-1  Transparent \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off \" data-aos=\"res-downIncoming\">\r\n \r\n\t\t  \r\n\t\t  <style>\r\n\t\t @media only screen and (min-width: 970px) {\r\n\t\t  #res-txt-block_95f72998a0c50621fd01df9f593cb504.res-txt .layout-2 .spalten-abstand { margin-right: 18%;}\r\n\t  <\/style>\r\n\t      \r\n    <div class=\"layout-2 txt-editor-spalten\">\r\n     <div class=\"row row-cols-1 row-cols-md- no-gutters\">\r\n\t \r\n\t\t \r\n        <!--   Spaltentext Loop Row  -->\r\n                                   <div class=\"col\">\r\n                     <div class=\"postContent\">\r\n\r\n                    <!--  Spalten Repeater  -->\r\n                                           \r\n                      <div class=\"row text-spalten-Box no-gutters \"> \r\n\r\n                            <div class=\"col-md-5 text-spalten-spalte01 \">\r\n                                <div class=\"spalten-abstand\">\r\n                                <h3>Validation Lifecycle Management<\/h3>\n<p>Governance of validation activities across all relevant systems and process lifecycles<\/p>\n                                <\/div>     \r\n                            <\/div>\r\n\r\n                            <div class=\"col-md text-spalten-spalte02 \">\r\n                              <h4>Focus:<\/h4>\n<ul>\n<li data-section-id=\"1iduzli\" data-start=\"640\" data-end=\"725\">Lifecycle governance from planning and execution through to ongoing maintenance<\/li>\n<li data-section-id=\"blld5f\" data-start=\"726\" data-end=\"807\">Alignment of validation documentation and outcomes across DQ, IQ, OQ and PQ<\/li>\n<li data-section-id=\"ywirlz\" data-start=\"808\" data-end=\"899\">Coordination of periodic reviews, requalification and ongoing validation requirements<\/li>\n<li data-section-id=\"r8ugzu\" data-start=\"900\" data-end=\"975\">Integration of changes, deviations and CAPA into lifecycle governance<\/li>\n<li data-section-id=\"1rxgcu8\" data-start=\"976\" data-end=\"1060\">Transparency regarding validation status, dependencies and critical path risks<\/li>\n<\/ul>\n                            <\/div>\r\n\r\n                      <\/div>\t\t\t\r\n\r\n                                           \r\n                    <\/div>\r\n                 <\/div>\r\n\r\n                                    <\/div> \r\n        <\/div>  \r\n\t \r\n\r\n     \r\n\t<\/div>\r\n<\/section>\r\n\r\n\n\n\r\n \r\n\r\n\r\n\r\n\r\n<section id=\"res-link-anker-block_cc20986661d7556eda41ff362feddd52\" class=\"linkanker-section\">\r\n<div  class=\"res-block res-link-anker style-standard py-1  Transparent  \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off\" data-aos=\"res-downIncoming\">\r\n\t\r\n\t\t<hr  >\r\n\t\t\r\n  \r\n\r\n\t<\/div>\r\n  <\/div>\r\n<\/section>\n\n\r\n\r\n\r\n<section id=\"res-txt-block_968d4dbb89c42e831abaca9fea2e00b4\" class=\"res-block res-txt style-standard layout02 py-1  Transparent \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off \" data-aos=\"res-downIncoming\">\r\n \r\n\t\t  \r\n\t\t  <style>\r\n\t\t @media only screen and (min-width: 970px) {\r\n\t\t  #res-txt-block_968d4dbb89c42e831abaca9fea2e00b4.res-txt .layout-2 .spalten-abstand { margin-right: 18%;}\r\n\t  <\/style>\r\n\t      \r\n    <div class=\"layout-2 txt-editor-spalten\">\r\n     <div class=\"row row-cols-1 row-cols-md- no-gutters\">\r\n\t \r\n\t\t \r\n        <!--   Spaltentext Loop Row  -->\r\n                                   <div class=\"col\">\r\n                     <div class=\"postContent\">\r\n\r\n                    <!--  Spalten Repeater  -->\r\n                                           \r\n                      <div class=\"row text-spalten-Box no-gutters \"> \r\n\r\n                            <div class=\"col-md-5 text-spalten-spalte01 \">\r\n                                <div class=\"spalten-abstand\">\r\n                                <h3>Impact of Changes and Validation Control<\/h3>\n<p>Assessment of the impact of changes on validation and determination of necessary control measures<\/p>\n                                <\/div>     \r\n                            <\/div>\r\n\r\n                            <div class=\"col-md text-spalten-spalte02 \">\r\n                              <h4>Focus:<\/h4>\n<ul>\n<li data-section-id=\"1f2zq6d\" data-start=\"372\" data-end=\"468\">Assessment of the GMP and validation implications of technical and process-related changes<\/li>\n<li data-section-id=\"15p599l\" data-start=\"469\" data-end=\"534\">Definition of requalification and revalidation requirements<\/li>\n<li data-section-id=\"1hcm1rh\" data-start=\"535\" data-end=\"619\">Integration of change control with risk assessment and implementation planning<\/li>\n<li data-section-id=\"jlb8wp\" data-start=\"620\" data-end=\"697\">Review of the impact on systems, equipment, processes and documentation<\/li>\n<li data-section-id=\"1syuynh\" data-start=\"698\" data-end=\"775\">Governance of validation-related decision-making and approval processes<\/li>\n<\/ul>\n                            <\/div>\r\n\r\n                      <\/div>\t\t\t\r\n\r\n                                           \r\n                    <\/div>\r\n                 <\/div>\r\n\r\n                                    <\/div> \r\n        <\/div>  \r\n\t \r\n\r\n     \r\n\t<\/div>\r\n<\/section>\r\n\r\n\n\n\r\n \r\n\r\n\r\n\r\n\r\n<section id=\"res-link-anker-block_cc20986661d7556eda41ff362feddd52\" class=\"linkanker-section\">\r\n<div  class=\"res-block res-link-anker style-standard py-1  Transparent  \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off\" data-aos=\"res-downIncoming\">\r\n\t\r\n\t\t<hr  >\r\n\t\t\r\n  \r\n\r\n\t<\/div>\r\n  <\/div>\r\n<\/section>\n\n\r\n\r\n\r\n<section id=\"res-txt-block_c1357a82bbc63c6f25571e450898325b\" class=\"res-block res-txt style-standard layout02 py-1  Transparent \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off \" data-aos=\"res-downIncoming\">\r\n \r\n\t\t  \r\n\t\t  <style>\r\n\t\t @media only screen and (min-width: 970px) {\r\n\t\t  #res-txt-block_c1357a82bbc63c6f25571e450898325b.res-txt .layout-2 .spalten-abstand { margin-right: 18%;}\r\n\t  <\/style>\r\n\t      \r\n    <div class=\"layout-2 txt-editor-spalten\">\r\n     <div class=\"row row-cols-1 row-cols-md- no-gutters\">\r\n\t \r\n\t\t \r\n        <!--   Spaltentext Loop Row  -->\r\n                                   <div class=\"col\">\r\n                     <div class=\"postContent\">\r\n\r\n                    <!--  Spalten Repeater  -->\r\n                                           \r\n                      <div class=\"row text-spalten-Box no-gutters \"> \r\n\r\n                            <div class=\"col-md-5 text-spalten-spalte01 \">\r\n                                <div class=\"spalten-abstand\">\r\n                                <h3>Continued Process Verification (CPV)<\/h3>\n<p>Strengthening process performance oversight through structured data analysis and regular review<\/p>\n                                <\/div>     \r\n                            <\/div>\r\n\r\n                            <div class=\"col-md text-spalten-spalte02 \">\r\n                              <h4>Focus:<\/h4>\n<ul>\n<li data-section-id=\"1mhrtns\" data-start=\"1032\" data-end=\"1099\">Definition of CPV objectives, parameters and evaluation logic<\/li>\n<li data-section-id=\"jrs0wx\" data-start=\"1100\" data-end=\"1198\">Alignment of the monitoring strategy with critical quality attributes and process parameters<\/li>\n<li data-section-id=\"1j75cq9\" data-start=\"1199\" data-end=\"1287\">Trend evaluation regarding process consistency, variability and early risk signals<\/li>\n<li data-section-id=\"18h79zv\" data-start=\"1288\" data-end=\"1370\">Integration of CPV results into management review and continuous improvement<\/li>\n<li data-section-id=\"m7svud\" data-start=\"1371\" data-end=\"1478\">Governance of escalation mechanisms for adverse trends and critical deviations in process performance<\/li>\n<\/ul>\n                            <\/div>\r\n\r\n                      <\/div>\t\t\t\r\n\r\n                                           \r\n                    <\/div>\r\n                 <\/div>\r\n\r\n                                    <\/div> \r\n        <\/div>  \r\n\t \r\n\r\n     \r\n\t<\/div>\r\n<\/section>\r\n\r\n\n\n\r\n \r\n\r\n\r\n\r\n\r\n<section id=\"res-link-anker-block_cc20986661d7556eda41ff362feddd52\" class=\"linkanker-section\">\r\n<div  class=\"res-block res-link-anker style-standard py-1  Transparent  \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off\" data-aos=\"res-downIncoming\">\r\n\t\r\n\t\t<hr  >\r\n\t\t\r\n  \r\n\r\n\t<\/div>\r\n  <\/div>\r\n<\/section>\n\n\r\n \r\n\r\n\r\n\r\n\r\n<section id=\"res-link-anker-block_a64d805b3e73d43e558137649732054d\" class=\"linkanker-section\">\r\n<div  class=\"res-block res-link-anker style-standard pt-5  Transparent  \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off\" data-aos=\"res-fadeIn\">\r\n\t\r\n\t\t\r\n  \r\n\r\n\t<\/div>\r\n  <\/div>\r\n<\/section>\n\n\r\n \r\n\r\n\r\n\r\n\r\n<section id=\"res-link-anker-block_cf4a3e439880f0335c7e48d2ab7b5872\" class=\"linkanker-section\">\r\n<div  id=\"datenintegritaet\"  class=\"res-block res-link-anker style-standard pt-1  Transparent  \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off\" data-aos=\"res-fadeIn\">\r\n\t\r\n\t\t\r\n  \r\n\r\n\t<\/div>\r\n  <\/div>\r\n<\/section>\n\n\r\n\r\n\r\n<section id=\"res-txt-block_252287505a9e885520d29daaf66e3fe4\" class=\"res-block res-txt style-02 layout01 py-2  Transparent \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off \" data-aos=\"res-topIncoming\">\r\n \r\n\t\t  \r\n\t\t \t  \r\n      \r\n      <div class=\"layout-1 txt-section text-left\">\r\n\t\t<div class=\"row layout-1-center \">\t\r\n\t\t\t\r\n\t\t\t\t\t<div class=\"col-md-10 var-1spalten \">\r\n\t\t\t\t\r\n\t\t\t\t<div class=\"txt-title-field\">\r\n\t\t\t\t\t\r\n\t\t\t\t\t\t\r\n\t\r\n\t\t\t\t\t\r\n\t\t\r\n\t\t\t\t  \r\n\t\t\t\t   <h2 class=\"title-h2 \">Data Integrity &amp; Digital Systems<\/h2>\r\n\t\t\t\t\r\n\t\t\t\t \r\n\t\t\t\t   <h3 class=\"title-h3 \">Risk Assessments for Data Integrity and Digital Systems<\/h3>\r\n\t\t\t\t\t\r\n\t\t\t\t\t \r\n\t\t\t\t\t<\/div>\r\n\r\n\t\t\t\t\r\n                \r\n\t\t\t\t\t            <\/div>\r\n\t\t\t\t <\/div> \t\r\n\t\t<\/div>\r\n\t \r\n\r\n     \r\n\t<\/div>\r\n<\/section>\r\n\r\n\n\n\r\n \r\n\r\n\r\n\r\n\r\n<section id=\"res-link-anker-block_cc20986661d7556eda41ff362feddd52\" class=\"linkanker-section\">\r\n<div  class=\"res-block res-link-anker style-standard py-1  Transparent  \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off\" data-aos=\"res-downIncoming\">\r\n\t\r\n\t\t<hr  >\r\n\t\t\r\n  \r\n\r\n\t<\/div>\r\n  <\/div>\r\n<\/section>\n\n\r\n\r\n\r\n<section id=\"res-txt-block_af4414a7e302b1ef90567105c842a82d\" class=\"res-block res-txt style-standard layout02 py-1  Transparent \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off \" data-aos=\"res-downIncoming\">\r\n \r\n\t\t  \r\n\t\t  <style>\r\n\t\t @media only screen and (min-width: 970px) {\r\n\t\t  #res-txt-block_af4414a7e302b1ef90567105c842a82d.res-txt .layout-2 .spalten-abstand { margin-right: 18%;}\r\n\t  <\/style>\r\n\t      \r\n    <div class=\"layout-2 txt-editor-spalten\">\r\n     <div class=\"row row-cols-1 row-cols-md- no-gutters\">\r\n\t \r\n\t\t \r\n        <!--   Spaltentext Loop Row  -->\r\n                                   <div class=\"col\">\r\n                     <div class=\"postContent\">\r\n\r\n                    <!--  Spalten Repeater  -->\r\n                                           \r\n                      <div class=\"row text-spalten-Box no-gutters \"> \r\n\r\n                            <div class=\"col-md-5 text-spalten-spalte01 \">\r\n                                <div class=\"spalten-abstand\">\r\n                                <h3>Risk Assessments for Data Integrity and Digital Systems<\/h3>\n<p>Structured identification of data integrity risks, control weaknesses and compliance gaps in digital systems<\/p>\n                                <\/div>     \r\n                            <\/div>\r\n\r\n                            <div class=\"col-md text-spalten-spalte02 \">\r\n                              <h4>Focus:<\/h4>\n<ul>\n<li data-section-id=\"1varaqk\" data-start=\"528\" data-end=\"611\">Risk-based assessment of data integrity in GMP-relevant systems and processes<\/li>\n<li data-section-id=\"17yk693\" data-start=\"612\" data-end=\"711\">Identification of control weaknesses in data generation, processing, validation and retention<\/li>\n<li data-section-id=\"5idy8r\" data-start=\"712\" data-end=\"779\">Assessment of system design, user roles and access governance<\/li>\n<li data-section-id=\"1m4xy13\" data-start=\"780\" data-end=\"852\">Review of critical interfaces, data flows and hybrid process risks<\/li>\n<li data-section-id=\"11pzh65\" data-start=\"853\" data-end=\"936\">Prioritisation of actions based on data integrity and compliance implications<\/li>\n<\/ul>\n                            <\/div>\r\n\r\n                      <\/div>\t\t\t\r\n\r\n                                           \r\n                    <\/div>\r\n                 <\/div>\r\n\r\n                                    <\/div> \r\n        <\/div>  \r\n\t \r\n\r\n     \r\n\t<\/div>\r\n<\/section>\r\n\r\n\n\n\r\n \r\n\r\n\r\n\r\n\r\n<section id=\"res-link-anker-block_cc20986661d7556eda41ff362feddd52\" class=\"linkanker-section\">\r\n<div  class=\"res-block res-link-anker style-standard py-1  Transparent  \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off\" data-aos=\"res-downIncoming\">\r\n\t\r\n\t\t<hr  >\r\n\t\t\r\n  \r\n\r\n\t<\/div>\r\n  <\/div>\r\n<\/section>\n\n\r\n\r\n\r\n<section id=\"res-txt-block_6ce9753407f08220dffd44a3421cc485\" class=\"res-block res-txt style-standard layout02 py-1  Transparent \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off \" data-aos=\"res-downIncoming\">\r\n \r\n\t\t  \r\n\t\t  <style>\r\n\t\t @media only screen and (min-width: 970px) {\r\n\t\t  #res-txt-block_6ce9753407f08220dffd44a3421cc485.res-txt .layout-2 .spalten-abstand { margin-right: 18%;}\r\n\t  <\/style>\r\n\t      \r\n    <div class=\"layout-2 txt-editor-spalten\">\r\n     <div class=\"row row-cols-1 row-cols-md- no-gutters\">\r\n\t \r\n\t\t \r\n        <!--   Spaltentext Loop Row  -->\r\n                                   <div class=\"col\">\r\n                     <div class=\"postContent\">\r\n\r\n                    <!--  Spalten Repeater  -->\r\n                                           \r\n                      <div class=\"row text-spalten-Box no-gutters \"> \r\n\r\n                            <div class=\"col-md-5 text-spalten-spalte01 \">\r\n                                <div class=\"spalten-abstand\">\r\n                                <h3>Implementation of ALCOA+<\/h3>\n<p>Implementation of ALCOA+ principles in operational controls, system design and day-to-day practice<\/p>\n                                <\/div>     \r\n                            <\/div>\r\n\r\n                            <div class=\"col-md text-spalten-spalte02 \">\r\n                              <h4>Focus:<\/h4>\n<ul>\n<li data-section-id=\"1obmguq\" data-start=\"259\" data-end=\"339\"><strong data-start=\"261\" data-end=\"339\">I<\/strong>ntegration of ALCOA+ principles into procedures, workflows and system use<\/li>\n<li data-section-id=\"13yo5rh\" data-start=\"340\" data-end=\"404\">Review of documentation practices and data review routines<\/li>\n<li data-section-id=\"fj17w8\" data-start=\"405\" data-end=\"476\">Alignment of user behaviour, training and procedural requirements<\/li>\n<li data-section-id=\"4ht5wv\" data-start=\"477\" data-end=\"562\">Strengthening controls for traceability, clear attribution and record integrity<\/li>\n<li data-section-id=\"179gpj0\" data-start=\"563\" data-end=\"635\">Embedding data integrity requirements in day-to-day GMP operations<\/li>\n<\/ul>\n                            <\/div>\r\n\r\n                      <\/div>\t\t\t\r\n\r\n                                           \r\n                    <\/div>\r\n                 <\/div>\r\n\r\n                                    <\/div> \r\n        <\/div>  \r\n\t \r\n\r\n     \r\n\t<\/div>\r\n<\/section>\r\n\r\n\n\n\r\n \r\n\r\n\r\n\r\n\r\n<section id=\"res-link-anker-block_cc20986661d7556eda41ff362feddd52\" class=\"linkanker-section\">\r\n<div  class=\"res-block res-link-anker style-standard py-1  Transparent  \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off\" data-aos=\"res-downIncoming\">\r\n\t\r\n\t\t<hr  >\r\n\t\t\r\n  \r\n\r\n\t<\/div>\r\n  <\/div>\r\n<\/section>\n\n\r\n\r\n\r\n<section id=\"res-txt-block_58ecab245cabfc79ec7654cc2e34d27d\" class=\"res-block res-txt style-standard layout02 py-1  Transparent \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off \" data-aos=\"res-downIncoming\">\r\n \r\n\t\t  \r\n\t\t  <style>\r\n\t\t @media only screen and (min-width: 970px) {\r\n\t\t  #res-txt-block_58ecab245cabfc79ec7654cc2e34d27d.res-txt .layout-2 .spalten-abstand { margin-right: 18%;}\r\n\t  <\/style>\r\n\t      \r\n    <div class=\"layout-2 txt-editor-spalten\">\r\n     <div class=\"row row-cols-1 row-cols-md- no-gutters\">\r\n\t \r\n\t\t \r\n        <!--   Spaltentext Loop Row  -->\r\n                                   <div class=\"col\">\r\n                     <div class=\"postContent\">\r\n\r\n                    <!--  Spalten Repeater  -->\r\n                                           \r\n                      <div class=\"row text-spalten-Box no-gutters \"> \r\n\r\n                            <div class=\"col-md-5 text-spalten-spalte01 \">\r\n                                <div class=\"spalten-abstand\">\r\n                                <h3>Data and System Monitoring<\/h3>\n<p>Assessment of governance, monitoring mechanisms and control effectiveness in digital GMP environments<\/p>\n                                <\/div>     \r\n                            <\/div>\r\n\r\n                            <div class=\"col-md text-spalten-spalte02 \">\r\n                              <h4>Focus:<\/h4>\n<ul>\n<li data-section-id=\"1sodjk7\" data-start=\"288\" data-end=\"382\">Assessment of monitoring and accountability structures for GMP-relevant data and systems<\/li>\n<li data-section-id=\"1pmvwir\" data-start=\"383\" data-end=\"465\">Review of periodic evaluations, exception handling and escalation mechanisms<\/li>\n<li data-section-id=\"ya2yhu\" data-start=\"466\" data-end=\"554\">Alignment of governance roles across business functions, Quality and system owners<\/li>\n<li data-section-id=\"1k96ro2\" data-start=\"555\" data-end=\"638\">Assessment of monitoring logic for critical records, events and system status<\/li>\n<li data-section-id=\"6rtv0v\" data-start=\"639\" data-end=\"737\">Strengthening management transparency regarding digital compliance risks and relevant trends<\/li>\n<\/ul>\n                            <\/div>\r\n\r\n                      <\/div>\t\t\t\r\n\r\n                                           \r\n                    <\/div>\r\n                 <\/div>\r\n\r\n                                    <\/div> \r\n        <\/div>  \r\n\t \r\n\r\n     \r\n\t<\/div>\r\n<\/section>\r\n\r\n\n\n\r\n \r\n\r\n\r\n\r\n\r\n<section id=\"res-link-anker-block_cc20986661d7556eda41ff362feddd52\" class=\"linkanker-section\">\r\n<div  class=\"res-block res-link-anker style-standard py-1  Transparent  \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off\" data-aos=\"res-downIncoming\">\r\n\t\r\n\t\t<hr  >\r\n\t\t\r\n  \r\n\r\n\t<\/div>\r\n  <\/div>\r\n<\/section>\n\n\r\n\r\n\r\n<section id=\"res-txt-block_8222d8bb1224e560f347a1f14c7d1e50\" class=\"res-block res-txt style-standard layout02 py-1  Transparent \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off \" data-aos=\"res-downIncoming\">\r\n \r\n\t\t  \r\n\t\t  <style>\r\n\t\t @media only screen and (min-width: 970px) {\r\n\t\t  #res-txt-block_8222d8bb1224e560f347a1f14c7d1e50.res-txt .layout-2 .spalten-abstand { margin-right: 18%;}\r\n\t  <\/style>\r\n\t      \r\n    <div class=\"layout-2 txt-editor-spalten\">\r\n     <div class=\"row row-cols-1 row-cols-md- no-gutters\">\r\n\t \r\n\t\t \r\n        <!--   Spaltentext Loop Row  -->\r\n                                   <div class=\"col\">\r\n                     <div class=\"postContent\">\r\n\r\n                    <!--  Spalten Repeater  -->\r\n                                           \r\n                      <div class=\"row text-spalten-Box no-gutters \"> \r\n\r\n                            <div class=\"col-md-5 text-spalten-spalte01 \">\r\n                                <div class=\"spalten-abstand\">\r\n                                <h3>Data Integrity in the Design of Digital Systems<\/h3>\n<p>Integration of data integrity requirements into the design, configuration and lifecycle governance of digital systems<\/p>\n                                <\/div>     \r\n                            <\/div>\r\n\r\n                            <div class=\"col-md text-spalten-spalte02 \">\r\n                              <h4>Focus:<\/h4>\n<ul>\n<li data-section-id=\"1tld82f\" data-start=\"1080\" data-end=\"1171\">Integration of data integrity requirements into system design and specification logic<\/li>\n<li data-section-id=\"197uejo\" data-start=\"1172\" data-end=\"1252\">Review of configuration principles for traceability and effective controls<\/li>\n<li data-section-id=\"qlp0hv\" data-start=\"1253\" data-end=\"1331\">Alignment of user roles, permissions and workflows with GMP requirements<\/li>\n<li data-section-id=\"ng8b67\" data-start=\"1332\" data-end=\"1415\">Consideration of requirements for audit trails, metadata and record retention<\/li>\n<li data-section-id=\"36r06y\" data-start=\"1416\" data-end=\"1510\">Strengthening lifecycle governance to ensure the sustainable embedding of data integrity<\/li>\n<\/ul>\n                            <\/div>\r\n\r\n                      <\/div>\t\t\t\r\n\r\n                                           \r\n                    <\/div>\r\n                 <\/div>\r\n\r\n                                    <\/div> \r\n        <\/div>  \r\n\t \r\n\r\n     \r\n\t<\/div>\r\n<\/section>\r\n\r\n\n\n\r\n \r\n\r\n\r\n\r\n\r\n<section id=\"res-link-anker-block_cc20986661d7556eda41ff362feddd52\" class=\"linkanker-section\">\r\n<div  class=\"res-block res-link-anker style-standard py-1  Transparent  \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off\" data-aos=\"res-downIncoming\">\r\n\t\r\n\t\t<hr  >\r\n\t\t\r\n  \r\n\r\n\t<\/div>\r\n  <\/div>\r\n<\/section>\n\n\r\n\r\n\r\n<section id=\"res-txt-block_a5dd6966832bda79a058fd09dff1fce9\" class=\"res-block res-txt style-standard layout02 py-1  Transparent \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off \" data-aos=\"res-downIncoming\">\r\n \r\n\t\t  \r\n\t\t  <style>\r\n\t\t @media only screen and (min-width: 970px) {\r\n\t\t  #res-txt-block_a5dd6966832bda79a058fd09dff1fce9.res-txt .layout-2 .spalten-abstand { margin-right: 18%;}\r\n\t  <\/style>\r\n\t      \r\n    <div class=\"layout-2 txt-editor-spalten\">\r\n     <div class=\"row row-cols-1 row-cols-md- no-gutters\">\r\n\t \r\n\t\t \r\n        <!--   Spaltentext Loop Row  -->\r\n                                   <div class=\"col\">\r\n                     <div class=\"postContent\">\r\n\r\n                    <!--  Spalten Repeater  -->\r\n                                           \r\n                      <div class=\"row text-spalten-Box no-gutters \"> \r\n\r\n                            <div class=\"col-md-5 text-spalten-spalte01 \">\r\n                                <div class=\"spalten-abstand\">\r\n                                <h3>Inspection Readiness for Data Integrity and Digital Systems<\/h3>\n<p>Structured preparation of digital GMP environments for regulatory inspections<\/p>\n                                <\/div>     \r\n                            <\/div>\r\n\r\n                            <div class=\"col-md text-spalten-spalte02 \">\r\n                              <h4>Focus:<\/h4>\n<ul>\n<li data-section-id=\"14tkual\" data-start=\"361\" data-end=\"451\">Assessment of inspection readiness for GMP-relevant computerised and digital systems<\/li>\n<li data-section-id=\"xcivv3\" data-start=\"452\" data-end=\"534\">Preparation of system narratives, integrity controls and evidence structures<\/li>\n<li data-section-id=\"f1p2\" data-start=\"535\" data-end=\"643\">Review of critical data flows, audit trail review and the handling of system exceptions and deviations<\/li>\n<li data-section-id=\"w31yc5\" data-start=\"644\" data-end=\"721\">Identification of likely inspection focus areas and critical interfaces<\/li>\n<li data-section-id=\"1fbdfje\" data-start=\"722\" data-end=\"827\">Preparation for inspection interviews and consistent responses to expected system-related questions<\/li>\n<\/ul>\n                            <\/div>\r\n\r\n                      <\/div>\t\t\t\r\n\r\n                                           \r\n                    <\/div>\r\n                 <\/div>\r\n\r\n                                    <\/div> \r\n        <\/div>  \r\n\t \r\n\r\n     \r\n\t<\/div>\r\n<\/section>\r\n\r\n\n\n\r\n \r\n\r\n\r\n\r\n\r\n<section id=\"res-link-anker-block_3a160c07d50076791a60e887449fe283\" class=\"linkanker-section\">\r\n<div  class=\"res-block res-link-anker style-standard py-1  Transparent  \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off\" data-aos=\"res-fadeIn\">\r\n\t\r\n\t\t<hr  >\r\n\t\t\r\n  \r\n\r\n\t<\/div>\r\n  <\/div>\r\n<\/section>\n\n\r\n \r\n\r\n\r\n\r\n\r\n<section id=\"res-link-anker-block_a64d805b3e73d43e558137649732054d\" class=\"linkanker-section\">\r\n<div  class=\"res-block res-link-anker style-standard pt-5  Transparent  \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off\" data-aos=\"res-fadeIn\">\r\n\t\r\n\t\t\r\n  \r\n\r\n\t<\/div>\r\n  <\/div>\r\n<\/section>\n\n\r\n \r\n\r\n\r\n\r\n\r\n<section id=\"res-link-anker-block_7c2076e9fdbb305a0ab09c41ded1ac0c\" class=\"linkanker-section\">\r\n<div  id=\"engineering\"  class=\"res-block res-link-anker style-standard pt-1  Transparent  \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off\" data-aos=\"res-fadeIn\">\r\n\t\r\n\t\t\r\n  \r\n\r\n\t<\/div>\r\n  <\/div>\r\n<\/section>\n\n\r\n\r\n\r\n<section id=\"res-txt-block_52b8c8a93f1c3c88c1c115ba1a5c5888\" class=\"res-block res-txt style-02 layout01 py-2  Transparent \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off \" data-aos=\"res-topIncoming\">\r\n \r\n\t\t  \r\n\t\t \t  \r\n      \r\n      <div class=\"layout-1 txt-section text-left\">\r\n\t\t<div class=\"row layout-1-center \">\t\r\n\t\t\t\r\n\t\t\t\t\t<div class=\"col-md-10 var-1spalten \">\r\n\t\t\t\t\r\n\t\t\t\t<div class=\"txt-title-field\">\r\n\t\t\t\t\t\r\n\t\t\t\t\t\t\r\n\t\r\n\t\t\t\t\t\r\n\t\t\r\n\t\t\t\t  \r\n\t\t\t\t   <h2 class=\"title-h2 \">Engineering &amp; GMP Projects<\/h2>\r\n\t\t\t\t\r\n\t\t\t\t \r\n\t\t\t\t   <h3 class=\"title-h3 \">GMP-Compliant Design, Qualification Strategies and Effective Project Governance<\/h3>\r\n\t\t\t\t\t\r\n\t\t\t\t\t \r\n\t\t\t\t\t<\/div>\r\n\r\n\t\t\t\t\r\n                \r\n\t\t\t\t\t            <\/div>\r\n\t\t\t\t <\/div> \t\r\n\t\t<\/div>\r\n\t \r\n\r\n     \r\n\t<\/div>\r\n<\/section>\r\n\r\n\n\n\r\n \r\n\r\n\r\n\r\n\r\n<section id=\"res-link-anker-block_cc20986661d7556eda41ff362feddd52\" class=\"linkanker-section\">\r\n<div  class=\"res-block res-link-anker style-standard py-1  Transparent  \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off\" data-aos=\"res-downIncoming\">\r\n\t\r\n\t\t<hr  >\r\n\t\t\r\n  \r\n\r\n\t<\/div>\r\n  <\/div>\r\n<\/section>\n\n\r\n  \r\n\t<style>\r\n\t\t#res-link-anker-block_0460b71e4e2803cb8bb60eff7e2f1672 .link-anker-with-no-padding {padding: 0 !important;}\r\n  <\/style> \r\n\r\n\r\n\r\n\r\n\r\n<section id=\"res-link-anker-block_0460b71e4e2803cb8bb60eff7e2f1672\" class=\"linkanker-section\">\r\n<div  class=\"res-block res-link-anker style-standard py-4  Transparent link-anker-with-no-padding \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off\" data-aos=\"res-fadeIn\">\r\n\t\r\n\t\t\r\n  \r\n\r\n\t<\/div>\r\n  <\/div>\r\n<\/section>\n\n\r\n\r\n\r\n<section id=\"res-txt-block_f8eedb4fd8867023c0837d680d511b89\" class=\"res-block res-txt style-standard layout02 py-1  Transparent \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off \" data-aos=\"res-downIncoming\">\r\n \r\n\t\t  \r\n\t\t  <style>\r\n\t\t @media only screen and (min-width: 970px) {\r\n\t\t  #res-txt-block_f8eedb4fd8867023c0837d680d511b89.res-txt .layout-2 .spalten-abstand { margin-right: 18%;}\r\n\t  <\/style>\r\n\t      \r\n    <div class=\"layout-2 txt-editor-spalten\">\r\n     <div class=\"row row-cols-1 row-cols-md- no-gutters\">\r\n\t \r\n\t\t \r\n        <!--   Spaltentext Loop Row  -->\r\n                                   <div class=\"col\">\r\n                     <div class=\"postContent\">\r\n\r\n                    <!--  Spalten Repeater  -->\r\n                                           \r\n                      <div class=\"row text-spalten-Box no-gutters \"> \r\n\r\n                            <div class=\"col-md-5 text-spalten-spalte01 \">\r\n                                <div class=\"spalten-abstand\">\r\n                                <h3>GMP Design Reviews<\/h3>\n<p>Structured review of GMP design requirements, compliance risks and implementation readiness<\/p>\n                                <\/div>     \r\n                            <\/div>\r\n\r\n                            <div class=\"col-md text-spalten-spalte02 \">\r\n                              <h4>Focus:<\/h4>\n<ul>\n<li data-section-id=\"8x6pzv\" data-start=\"314\" data-end=\"400\">Review of GMP-relevant design principles for facilities, utilities and equipment<\/li>\n<li data-section-id=\"36pcto\" data-start=\"401\" data-end=\"476\">Assessment of GMP-critical design assumptions and boundary conditions<\/li>\n<li data-section-id=\"180dk9z\" data-start=\"477\" data-end=\"560\">Assessment of layouts and material and personnel flows from a GMP perspective<\/li>\n<li data-section-id=\"1m64vr3\" data-start=\"561\" data-end=\"637\">Identification of design-related risks for qualification and operation<\/li>\n<li data-section-id=\"18l76fr\" data-start=\"638\" data-end=\"722\">Alignment of design decisions with GMP expectations and lifecycle requirements<\/li>\n<\/ul>\n                            <\/div>\r\n\r\n                      <\/div>\t\t\t\r\n\r\n                                           \r\n                    <\/div>\r\n                 <\/div>\r\n\r\n                                    <\/div> \r\n        <\/div>  \r\n\t \r\n\r\n     \r\n\t<\/div>\r\n<\/section>\r\n\r\n\n\n\r\n \r\n\r\n\r\n\r\n\r\n<section id=\"res-link-anker-block_cc20986661d7556eda41ff362feddd52\" class=\"linkanker-section\">\r\n<div  class=\"res-block res-link-anker style-standard py-1  Transparent  \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off\" data-aos=\"res-downIncoming\">\r\n\t\r\n\t\t<hr  >\r\n\t\t\r\n  \r\n\r\n\t<\/div>\r\n  <\/div>\r\n<\/section>\n\n\r\n\r\n\r\n<section id=\"res-txt-block_d0629017e52d03fadb21991c3821d2cd\" class=\"res-block res-txt style-standard layout02 py-1  Transparent \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off \" data-aos=\"res-downIncoming\">\r\n \r\n\t\t  \r\n\t\t  <style>\r\n\t\t @media only screen and (min-width: 970px) {\r\n\t\t  #res-txt-block_d0629017e52d03fadb21991c3821d2cd.res-txt .layout-2 .spalten-abstand { margin-right: 18%;}\r\n\t  <\/style>\r\n\t      \r\n    <div class=\"layout-2 txt-editor-spalten\">\r\n     <div class=\"row row-cols-1 row-cols-md- no-gutters\">\r\n\t \r\n\t\t \r\n        <!--   Spaltentext Loop Row  -->\r\n                                   <div class=\"col\">\r\n                     <div class=\"postContent\">\r\n\r\n                    <!--  Spalten Repeater  -->\r\n                                           \r\n                      <div class=\"row text-spalten-Box no-gutters \"> \r\n\r\n                            <div class=\"col-md-5 text-spalten-spalte01 \">\r\n                                <div class=\"spalten-abstand\">\r\n                                <h3>URS Reviews<\/h3>\n<p>Assessment of user requirements for GMP relevance, clarity and suitability for qualification<\/p>\n                                <\/div>     \r\n                            <\/div>\r\n\r\n                            <div class=\"col-md text-spalten-spalte02 \">\r\n                              <h4>Focus:<\/h4>\n<ul>\n<li data-section-id=\"7a000m\" data-start=\"1624\" data-end=\"1713\">Verification of the completeness, clarity and GMP relevance of the URS<\/li>\n<li data-section-id=\"7a000m\" data-start=\"1624\" data-end=\"1713\">Assessment of end-to-end traceability from the URS through the design to the qualification documentation<\/li>\n<li data-section-id=\"7a000m\" data-start=\"1624\" data-end=\"1713\">Identification of ambiguous, missing or unverifiable requirements<\/li>\n<li data-section-id=\"7a000m\" data-start=\"1624\" data-end=\"1713\">Alignment of the URS structure with the requirements for DQ, IQ, OQ and PQ<\/li>\n<li data-section-id=\"7a000m\" data-start=\"1624\" data-end=\"1713\">Strengthening the quality of requirements as the foundation for GMP-compliant project execution<\/li>\n<\/ul>\n                            <\/div>\r\n\r\n                      <\/div>\t\t\t\r\n\r\n                                           \r\n                    <\/div>\r\n                 <\/div>\r\n\r\n                                    <\/div> \r\n        <\/div>  \r\n\t \r\n\r\n     \r\n\t<\/div>\r\n<\/section>\r\n\r\n\n\n\r\n \r\n\r\n\r\n\r\n\r\n<section id=\"res-link-anker-block_cc20986661d7556eda41ff362feddd52\" class=\"linkanker-section\">\r\n<div  class=\"res-block res-link-anker style-standard py-1  Transparent  \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off\" data-aos=\"res-downIncoming\">\r\n\t\r\n\t\t<hr  >\r\n\t\t\r\n  \r\n\r\n\t<\/div>\r\n  <\/div>\r\n<\/section>\n\n\r\n\r\n\r\n<section id=\"res-txt-block_5da736321df6bfdc44a9eba020606ed6\" class=\"res-block res-txt style-standard layout02 py-1  Transparent \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off \" data-aos=\"res-downIncoming\">\r\n \r\n\t\t  \r\n\t\t  <style>\r\n\t\t @media only screen and (min-width: 970px) {\r\n\t\t  #res-txt-block_5da736321df6bfdc44a9eba020606ed6.res-txt .layout-2 .spalten-abstand { margin-right: 18%;}\r\n\t  <\/style>\r\n\t      \r\n    <div class=\"layout-2 txt-editor-spalten\">\r\n     <div class=\"row row-cols-1 row-cols-md- no-gutters\">\r\n\t \r\n\t\t \r\n        <!--   Spaltentext Loop Row  -->\r\n                                   <div class=\"col\">\r\n                     <div class=\"postContent\">\r\n\r\n                    <!--  Spalten Repeater  -->\r\n                                           \r\n                      <div class=\"row text-spalten-Box no-gutters \"> \r\n\r\n                            <div class=\"col-md-5 text-spalten-spalte01 \">\r\n                                <div class=\"spalten-abstand\">\r\n                                <h3>Engineering Risk Assessments<\/h3>\n<p>Structured assessment of engineering risks affecting GMP compliance, operability and qualification<\/p>\n                                <\/div>     \r\n                            <\/div>\r\n\r\n                            <div class=\"col-md text-spalten-spalte02 \">\r\n                              <h4>Focus:<\/h4>\n<ul>\n<li data-section-id=\"uoclv4\" data-start=\"506\" data-end=\"594\">Identification of engineering risks with potential implications for GMP compliance<\/li>\n<li data-section-id=\"1r19gwr\" data-start=\"595\" data-end=\"699\">Assessment of technical decisions regarding operability, cleanability and maintenance requirements<\/li>\n<li data-section-id=\"jdff5l\" data-start=\"700\" data-end=\"791\">Review of interfaces between design, process requirements and compliance expectations<\/li>\n<li data-section-id=\"16gfpcw\" data-start=\"792\" data-end=\"885\">Assessment of risk mitigation measures throughout the project and implementation phases<\/li>\n<li data-section-id=\"xcbdss\" data-start=\"886\" data-end=\"986\">Prioritisation of engineering risks requiring escalation or additional risk reduction measures<\/li>\n<\/ul>\n                            <\/div>\r\n\r\n                      <\/div>\t\t\t\r\n\r\n                                           \r\n                    <\/div>\r\n                 <\/div>\r\n\r\n                                    <\/div> \r\n        <\/div>  \r\n\t \r\n\r\n     \r\n\t<\/div>\r\n<\/section>\r\n\r\n\n\n\r\n \r\n\r\n\r\n\r\n\r\n<section id=\"res-link-anker-block_cc20986661d7556eda41ff362feddd52\" class=\"linkanker-section\">\r\n<div  class=\"res-block res-link-anker style-standard py-1  Transparent  \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off\" data-aos=\"res-downIncoming\">\r\n\t\r\n\t\t<hr  >\r\n\t\t\r\n  \r\n\r\n\t<\/div>\r\n  <\/div>\r\n<\/section>\n\n\r\n\r\n\r\n<section id=\"res-txt-block_056b9ef7b64d47d6b1e27ffba116c575\" class=\"res-block res-txt style-standard layout02 py-1  Transparent \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off \" data-aos=\"res-downIncoming\">\r\n \r\n\t\t  \r\n\t\t  <style>\r\n\t\t @media only screen and (min-width: 970px) {\r\n\t\t  #res-txt-block_056b9ef7b64d47d6b1e27ffba116c575.res-txt .layout-2 .spalten-abstand { margin-right: 18%;}\r\n\t  <\/style>\r\n\t      \r\n    <div class=\"layout-2 txt-editor-spalten\">\r\n     <div class=\"row row-cols-1 row-cols-md- no-gutters\">\r\n\t \r\n\t\t \r\n        <!--   Spaltentext Loop Row  -->\r\n                                   <div class=\"col\">\r\n                     <div class=\"postContent\">\r\n\r\n                    <!--  Spalten Repeater  -->\r\n                                           \r\n                      <div class=\"row text-spalten-Box no-gutters \"> \r\n\r\n                            <div class=\"col-md-5 text-spalten-spalte01 \">\r\n                                <div class=\"spalten-abstand\">\r\n                                <h3>Commissioning and Qualification Strategies<\/h3>\n<p>Development of a risk-based strategy for coordinated commissioning and qualification execution<\/p>\n                                <\/div>     \r\n                            <\/div>\r\n\r\n                            <div class=\"col-md text-spalten-spalte02 \">\r\n                              <h4>Focus:<\/h4>\n<ul>\n<li data-section-id=\"1mcm9hc\" data-start=\"303\" data-end=\"395\">Definition of scope, sequence and responsibilities for commissioning and qualification<\/li>\n<li data-section-id=\"3fim1t\" data-start=\"396\" data-end=\"481\">Alignment of the C&amp;Q strategy with project milestones and operational readiness<\/li>\n<li data-section-id=\"15boypu\" data-start=\"482\" data-end=\"574\">Integration of design, testing and documentation logic across all involved disciplines<\/li>\n<li data-section-id=\"10oaxge\" data-start=\"575\" data-end=\"665\">Identification of implementation dependencies, handover risks and unclear interfaces<\/li>\n<li data-section-id=\"s30o7\" data-start=\"666\" data-end=\"742\">Coordinated oversight of qualification progress and critical decisions<\/li>\n<\/ul>\n                            <\/div>\r\n\r\n                      <\/div>\t\t\t\r\n\r\n                                           \r\n                    <\/div>\r\n                 <\/div>\r\n\r\n                                    <\/div> \r\n        <\/div>  \r\n\t \r\n\r\n     \r\n\t<\/div>\r\n<\/section>\r\n\r\n\n\n\r\n \r\n\r\n\r\n\r\n\r\n<section id=\"res-link-anker-block_cc20986661d7556eda41ff362feddd52\" class=\"linkanker-section\">\r\n<div  class=\"res-block res-link-anker style-standard py-1  Transparent  \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off\" data-aos=\"res-downIncoming\">\r\n\t\r\n\t\t<hr  >\r\n\t\t\r\n  \r\n\r\n\t<\/div>\r\n  <\/div>\r\n<\/section>\n\n\r\n\r\n\r\n<section id=\"res-txt-block_0cbd38778fca7377cd5380b01a058666\" class=\"res-block res-txt style-standard layout02 py-1  Transparent \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off \" data-aos=\"res-downIncoming\">\r\n \r\n\t\t  \r\n\t\t  <style>\r\n\t\t @media only screen and (min-width: 970px) {\r\n\t\t  #res-txt-block_0cbd38778fca7377cd5380b01a058666.res-txt .layout-2 .spalten-abstand { margin-right: 18%;}\r\n\t  <\/style>\r\n\t      \r\n    <div class=\"layout-2 txt-editor-spalten\">\r\n     <div class=\"row row-cols-1 row-cols-md- no-gutters\">\r\n\t \r\n\t\t \r\n        <!--   Spaltentext Loop Row  -->\r\n                                   <div class=\"col\">\r\n                     <div class=\"postContent\">\r\n\r\n                    <!--  Spalten Repeater  -->\r\n                                           \r\n                      <div class=\"row text-spalten-Box no-gutters \"> \r\n\r\n                            <div class=\"col-md-5 text-spalten-spalte01 \">\r\n                                <div class=\"spalten-abstand\">\r\n                                <h3>Project Governance Reviews<\/h3>\n<p>Independent review of governance structures, decision pathways and execution oversight in GMP-critical projects<\/p>\n                                <\/div>     \r\n                            <\/div>\r\n\r\n                            <div class=\"col-md text-spalten-spalte02 \">\r\n                              <h4>Focus:<\/h4>\n<ul>\n<li data-section-id=\"1brv9df\" data-start=\"1045\" data-end=\"1136\">Assessment of governance roles, project accountability and decision-making structures<\/li>\n<li data-section-id=\"159v3s9\" data-start=\"1137\" data-end=\"1216\">Review of escalation pathways, interface clarity and management oversight<\/li>\n<li data-section-id=\"1b331v3\" data-start=\"1217\" data-end=\"1307\">Identification of structural weaknesses affecting schedule objectives and compliance<\/li>\n<li data-section-id=\"oj9zl5\" data-start=\"1308\" data-end=\"1389\">Assessment of planning realism, dependency management and execution control<\/li>\n<li data-section-id=\"a25er0\" data-start=\"1390\" data-end=\"1452\">Strengthening governance and improving project stability<\/li>\n<\/ul>\n                            <\/div>\r\n\r\n                      <\/div>\t\t\t\r\n\r\n                                           \r\n                    <\/div>\r\n                 <\/div>\r\n\r\n                                    <\/div> \r\n        <\/div>  \r\n\t \r\n\r\n     \r\n\t<\/div>\r\n<\/section>\r\n\r\n\n\n\r\n \r\n\r\n\r\n\r\n\r\n<section id=\"res-link-anker-block_190a875c3265f2266b8b6b1c9ee457e2\" class=\"linkanker-section\">\r\n<div  class=\"res-block res-link-anker style-standard pb-5  Transparent  \" style=\"background: transparent;\">\r\n  <div class=\"inner-container container-off\" data-aos=\"res-fadeIn\">\r\n\t\r\n\t\t<hr  >\r\n\t\t\r\n  \r\n\r\n\t<\/div>\r\n  <\/div>\r\n<\/section>","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-6261","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/gmpca.ch\/en\/wp-json\/wp\/v2\/pages\/6261","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/gmpca.ch\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/gmpca.ch\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/gmpca.ch\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/gmpca.ch\/en\/wp-json\/wp\/v2\/comments?post=6261"}],"version-history":[{"count":61,"href":"https:\/\/gmpca.ch\/en\/wp-json\/wp\/v2\/pages\/6261\/revisions"}],"predecessor-version":[{"id":6546,"href":"https:\/\/gmpca.ch\/en\/wp-json\/wp\/v2\/pages\/6261\/revisions\/6546"}],"wp:attachment":[{"href":"https:\/\/gmpca.ch\/en\/wp-json\/wp\/v2\/media?parent=6261"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}