{"id":32065,"date":"2023-10-02T06:06:44","date_gmt":"2023-10-02T06:06:44","guid":{"rendered":"https:\/\/www.process.st\/templates\/cfr-21-part-11-compliance-checklist\/"},"modified":"2024-03-05T14:20:33","modified_gmt":"2024-03-05T14:20:33","slug":"cfr-21-part-11-compliance-checklist","status":"publish","type":"post","link":"https:\/\/www.process.st\/templates\/cfr-21-part-11-compliance-checklist\/","title":{"rendered":"CFR 21 Part 11 Compliance Checklist"},"content":{"rendered":"\n<section id=\"identify-applicable-systems-for-cfr-21-part-11-compliance\"> \n <h2>Identify applicable systems for CFR 21 Part 11 compliance<\/h2>\n <div class=\"text-content\">\n   This task involves identifying the systems within the organization that need to comply with CFR 21 Part 11 regulations. The goal is to ensure that all relevant systems are included in the compliance process. Consider the impact on the overall process and the desired results. Are there any challenges in identifying the systems? What resources or tools can be used to assist in this task? \n <\/div> \n <div class=\"text-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Name of the system <\/label> \n   <input type=\"text\" placeholder=\"Something will be typed here...\" disabled class=\"form-control\"> \n  <\/div> \n <\/div> \n <div class=\"select-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> System type <\/label> <select disabled class=\"form-control\"> <option value=\"An option will be selected here\">An option will be selected here<\/option> <\/select> \n  <\/div> \n  <ul class=\"items\"> \n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       1 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      ERP \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       2 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      CRM \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       3 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Document Management \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       4 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Lab Management \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       5 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Quality Management \n    <\/div> <\/li> \n  <\/ul> \n <\/div> \n<\/section> \n<section id=\"conduct-an-inventory-and-analysis-of-current-software\"> \n <h2>Conduct an inventory and analysis of current software<\/h2>\n <div class=\"text-content\">\n   This task involves conducting an inventory and analysis of the current software used within the organization. The goal is to determine if the software can meet the requirements for CFR 21 Part 11 compliance. Consider the impact on the overall process and the desired results. What information or data needs to be collected for the analysis? Are there any challenges in conducting the inventory? What resources or tools can be used for this task? \n <\/div> \n <div class=\"text-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Current software name <\/label> \n   <input type=\"text\" placeholder=\"Something will be typed here...\" disabled class=\"form-control\"> \n  <\/div> \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Description of the software <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n <div class=\"multi-select-content form-field-content\"> \n  <div class=\"form-group\"> <label> Inventory checklist <\/label> \n  <\/div> \n  <ul class=\"items\"> \n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       1 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Version number \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       2 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Vendor information \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       3 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Functionality \n    <\/div> <\/li> \n  <\/ul> \n <\/div> \n<\/section> \n<section id=\"establish-validation-plan\"> \n <h2>Establish Validation Plan<\/h2>\n <div class=\"text-content\">\n   This task involves establishing a validation plan for the systems identified for CFR 21 Part 11 compliance. The goal is to outline the steps and activities required to validate the systems. Consider the impact on the overall process and the desired results. How will the validation plan be developed? What information or data needs to be included in the plan? Are there any challenges in establishing the plan? What resources or tools can be used for this task? \n <\/div> \n <div class=\"text-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Validation plan name <\/label> \n   <input type=\"text\" placeholder=\"Something will be typed here...\" disabled class=\"form-control\"> \n  <\/div> \n <\/div> \n <div class=\"multi-choice-content form-field-content\"> \n  <div class=\"form-group\"> <label> Validation plan activities <\/label> <select disabled class=\"form-control\"> <option value=\"\">Multiple options can be selected from this list<\/option> <\/select> \n  <\/div> \n  <ul class=\"items\"> \n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       1 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Define validation objectives \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       2 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Perform risk assessment \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       3 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Develop test scripts \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       4 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Execute test scripts \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       5 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Document validation results \n    <\/div> <\/li> \n  <\/ul> \n <\/div> \n<\/section> \n<section id=\"check-system-for-electronic-record-keeping-ability\"> \n <h2>Check system for electronic record keeping ability<\/h2> \n<\/section> \n<section id=\"ensure-system-has-an-audit-trail-feature\"> \n <h2>Ensure system has an audit trail feature<\/h2> \n<\/section> \n<section id=\"review-procedures-for-system-backups\"> \n <h2>Review procedures for system backups<\/h2> \n<\/section> \n<section id=\"determine-protection-measures-for-electronic-signatures\"> \n <h2>Determine protection measures for electronic signatures<\/h2> \n<\/section> \n<section id=\"approval-electronic-signature-protection\"> \n <h2>Approval: Electronic Signature Protection<\/h2>\n <div class=\"approval-content\"> \n  <div class=\"header\"> \n   <div class=\"list-title\">\n    Will be submitted for approval:\n   <\/div> \n  <\/div> \n  <div class=\"approval-rule-subject-tasks-list\"> \n   <ul class=\"list\"> \n    <li> \n     <div class=\"approval-rule-subject-tasks-list-item\"> \n      <div class=\"item\"> \n       <div class=\"container\"> <span class=\"title\">Determine protection measures for electronic signatures<\/span> \n        <div class=\"body\">\n         Will be submitted\n        <\/div> \n       <\/div> \n      <\/div> \n     <\/div> <\/li> \n   <\/ul> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"evaluate-software-operational-controls\"> \n <h2>Evaluate software operational controls<\/h2> \n<\/section> \n<section id=\"identify-training-needs-for-users\"> \n <h2>Identify training needs for users<\/h2> \n<\/section> \n<section id=\"establish-protocols-for-alterations-and-modifications\"> \n <h2>Establish protocols for alterations and modifications<\/h2> \n<\/section> \n<section id=\"develop-control-for-record-distribution\"> \n <h2>Develop control for record distribution<\/h2> \n<\/section> \n<section id=\"implement-documented-policy-for-system-use\"> \n <h2>Implement documented policy for system use<\/h2> \n<\/section> \n<section id=\"review-procedures-for-system-maintenance\"> \n <h2>Review procedures for system maintenance<\/h2> \n<\/section> \n<section id=\"approval-system-maintenance-procedures\"> \n <h2>Approval: system maintenance procedures<\/h2>\n <div class=\"approval-content\"> \n  <div class=\"header\"> \n   <div class=\"list-title\">\n    Will be submitted for approval:\n   <\/div> \n  <\/div> \n  <div class=\"approval-rule-subject-tasks-list\"> \n   <ul class=\"list\"> \n    <li> \n     <div class=\"approval-rule-subject-tasks-list-item\"> \n      <div class=\"item\"> \n       <div class=\"container\"> <span class=\"title\">Review procedures for system maintenance<\/span> \n        <div class=\"body\">\n         Will be submitted\n        <\/div> \n       <\/div> \n      <\/div> \n     <\/div> <\/li> \n   <\/ul> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"execute-periodic-review-strategy\"> \n <h2>Execute Periodic Review Strategy<\/h2> \n<\/section> \n<section id=\"ensure-interoperability-among-system-components\"> \n <h2>Ensure interoperability among system components<\/h2> \n<\/section> \n<section id=\"assess-data-integrity-and-confidentiality-measures\"> \n <h2>Assess data integrity and confidentiality measures<\/h2> \n<\/section> \n<section id=\"approval-data-integrity-and-confidentiality-measures\"> \n <h2>Approval: Data Integrity and Confidentiality Measures<\/h2>\n <div class=\"approval-content\"> \n  <div class=\"header\"> \n   <div class=\"list-title\">\n    Will be submitted for approval:\n   <\/div> \n  <\/div> \n  <div class=\"approval-rule-subject-tasks-list\"> \n   <ul class=\"list\"> \n    <li> \n     <div class=\"approval-rule-subject-tasks-list-item\"> \n      <div class=\"item\"> \n       <div class=\"container\"> <span class=\"title\">Assess data integrity and confidentiality measures<\/span> \n        <div class=\"body\">\n         Will be submitted\n        <\/div> \n       <\/div> \n      <\/div> \n     <\/div> <\/li> \n   <\/ul> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"close-project-after-ensuring-compliance\"> \n <h2>Close project after ensuring compliance<\/h2> \n<\/section>\n","protected":false},"excerpt":{"rendered":"<p>Identify applicable systems for CFR 21 Part 11 compliance This task involves identifying the systems within the organization that need to comply with CFR 21 Part 11 regulations. The goal is to ensure that all relevant systems are included in the compliance process. Consider the impact on the overall process and the desired results. Are [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"ep_exclude_from_search":false,"cover_icon_emoji":"\ud83d\udcdd","cover_icon_url":"","tasks_count":"20","template_description":"","template_id":"hGKDzBEdnkVeUxPrdYlGjA","task_0":"Identify applicable systems for CFR 21 Part 11 compliance","task_slug_0":"identify-applicable-systems-for-cfr-21-part-11-compliance","task_1":"Conduct an inventory and analysis of current software","task_slug_1":"conduct-an-inventory-and-analysis-of-current-software","task_2":"Establish Validation Plan","task_slug_2":"establish-validation-plan","task_3":"Check system for electronic record keeping ability","task_slug_3":"check-system-for-electronic-record-keeping-ability","task_4":"Ensure system has an audit trail feature","task_slug_4":"ensure-system-has-an-audit-trail-feature","task_5":"Review procedures for system 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