Overview

The training module of the Controlled Document Management application now includes a Course Management capability. You can create a course with multiple documents to manage training assignments for individual users or groups.

Training courses support the following:

  • Courses with multiple documents
  • Courses with multiple assignees.  Assignees can be individual users or groups.
  • An optional recurrence period so assignees can be retrained on the documents from the course periodically.  
  • Automated training assignments for new users added to assigned groups.
  • Generated training assignments that require assignees to view the document and acknowledge the completion of the training assignment by providing a 21 CFR Part 11 compliant Digital signature.
  • Automated email notifications to assignees and training managers.
  • Complete audit trail on all the actions performed related to course creation, course modification, and the training assignments.
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Accessing Course Management Features

The Course Management features are accessed through the Controlled Document Management. This page allows the users to create, view, and edit courses. By default, the page shows Active and Pending status courses, but the courses which have been canceled can be shown by changing the Status filter. Additional filters are available to show the course(s) assigned to specific users/groups or course(s) created from the specific category.


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You can export the following course related data from this page: 

  • Course Training history export for each individual course.
  • Course List export includes a list of courses along with other course related information such as course status, assignees, start date, creator and who last modified the course. 
  • Course to Documents export includes the list of documents included in each course.

The Course Management section is available to:

  • Domain administrators
  • Users with a role that grants the “can manage Controlled Documents” capability
  • Users who are added as a Category Manager to one or more Document Categories

How to Create a New Course?

  1. Navigate to the Course Management page.
  2. Click the New Course button on the top right corner of the page.
  3. The Create New Course dialog will be shown with a form to fill out course parameters.

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  4. Enter a unique Course name with a minimum of 3 and a maximum of 50 characters.
  5. Enter Course description with a minimum of 3 and a maximum of 100 characters.
  6. The Course start date defines when the course will become active. You can choose the current or any date in the future.
  7. The Days to complete field defines the number of days assignees will have to complete the training assignments created from the course. You can enter any number between 1 to 365 in Days to complete field. Each time a new training assignment is created from the course, it shall have a due date defined based on the number of days entered in this field.
  8. You have an option to skip the training assignments of the documents which are close to becoming obsolete. If any of the selected document versions are close to becoming obsolete, then based on the number of days entered in Do not create training assignment if document version becomes obsolete in, day(s) field, the training assignments for those documents will not be created from the course. By default, this field is pre-populated with 0 days meaning no training assignments will be skipped.
  9. Select the checkbox for Make this course recurring if you want to retrain the assignees periodically on the documents from this course. Once the Make this course recurring option is selected, Recurrence Period, day(s) field is displayed and you can enter any value greater or equal to 1 in this field. The training assignments will be created based on the last date that the assignee trained on the document from when they are added to a course.
  10. Select the category from the Document category dropdown list. After selecting the category, a list of the effective and future effective document versions from the selected category is shown. 
  11. You can select the document version you would like to add to the course by clicking the checkbox in front of each document version.
  12. Search and enter the names of an individual user(s) or group(s) in the Course assignee(s) field.
  13. Click “Assign Course” to create the new course and assign it to the user(s)/group(s) entered into the previous step.
  14. You can edit or cancel any active or pending status course by clicking the three vertical dots menu icon.

How are the Training Assignments Created from the Course?

  • Course assignees will receive individual training assignments for each document in the course. 
  • When a new user is added to a group that is assigned to the course then the user will automatically receive the training assignments on the documents from the course, even if the user is added after the course is created.
  • Users who have already completed training on a document prior to being added to the course will not be assigned the document unless the course has a retraining period and that time period has been exceeded since the user’s last training on the document.

If the assignee already has a pending or overdue training assignment for the same document version before being added to the course, then a new training assignment will not be created from the course

How to View Training Records?

Category managers and Controlled Document Management app admins can view the training records for all the training assignments created from the course on Trainings I Manage page. To learn more about viewing training records, refer to “How to view Training records?”.

If the training assignment is created from the course then the course name is shown in the “Assigned By” column of Trainings I Manage page and downloaded CSV training records. 

How to View and Complete a Training Assignment?

Whether the training is assigned ad hoc or through a course, the training assignees’ experience remains the same. When training assignments are created from a course, the assignee receives an email notification for each assignment that contains the link to the document, the name of the course, and the training due date. 

Training assignees can view the document and indicate that they have read and understood the content of the document. The training assignees can acknowledge the completion of training by providing a 21 CFR Part 11 compliant digital signature. Learn more about completing training assignments.