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Adding Quality Documents to the Controlled Document Management Application

Overview

Adding a controlled document associates metadata to a document (an identifier, effective dates, etc.) and makes it available in the Controlled Document Management application to users with access to the category.  This article covers adding new documents and adding an updated version of an existing document to the Controlled Document Management application.

Adding a New Document

To add a new document, perform the following steps:

  1. Create a draft document that is in the folder (or one of its subfolders) associated with the document category you would like the document to reside within
  2. Complete and approve a review and approval workflow that includes an approval step
  3. A Category manager will see an option at the bottom of the workflow to Mark Approved Version as Effective

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  4. A Make document effective dialog will be shown with a form with document metadata fields.  All fields are required.

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    1. Keep the default "New effective document" to create a new document with a new identifier.
    2. The Document Category is read-only and based on the folder that the file belongs to.
    3. Choose one of the Document Subcategories associated with the category.
    4. The system will provide a default document identifier based on the next available number for the prefix based on the subcategory you have selected. You can change this to another number as long as that identifier isn't already being used for another document. For example, if SOP-1, SOP-2, and SOP-8 already exist, the system will suggest the next available identifier, SOP-3. You can change this to other unique identifiers such as SOP-10, SOP-100 but not SOP-1, SOP-2, and SOP-8.
    5. By default, the Document Version name is set to the file name without the extension.  You can change this to any other value.
    6. The Effective document version has a default of 1.0 but can be changed to another number in the X.Y format, e.g., 1.0, 2.0, 2.1, etc.
    7. The Effective on date controls when the document will become effective.  You can choose the current day or any day in the future, but not the previous days. If you choose the current day then the document will become effective immediately. 
    8. The Effective until date controls when the document's effectiveness will end.  You can set this for a time period (e.g., a year) and then later choose to extend this date after periodic review before the expiration.  If a document passes its effective until date, the document will move to an Obsolete status.
  5. Click "Make Effective" to save the metadata.

After adding the document, it will be added to the Controlled Document Management application and will be in an Effective or a Future Effective state.  For the documents in Future Effective state, once the Effective on date is reached, the document status will automatically be changed to Effective.

Adding a New Version of a Document

To update an existing quality document to a new version (e.g., version 1.0 to version 2.0), perform the following steps:

  1. Create a draft document in the folder (or one of its subfolders) associated with the document category you would like the quality document to reside within.  This document can either be a separate file on the file system from the original document or a new version of the same file.
  2. Complete and approve a review and approval workflow that includes an approval step
  3. A Category manager will see an option at the bottom of the workflow to Mark Approved Version as Effective.
  4. Make document effective dialog will be shown with a form with document metadata fields.  All fields are required.
    1. Choose the "New version of an existing effective document" to start the process.
    2. In the Document field, find the document you'd like to update.  You can type to search by the identifier or document name.  The dropdown only shows documents from the category associated with the folder the document resides in.
    3. By default, the Document Version name is set to the current value of the existing effective document.  You can change this to any other value.
    4. Choose an Effective document version that is a higher number than the existing number.  The existing version number is shown for reference.
    5. The Effective on date controls when the document will become effective.  The effective until date of the existing effective document is shown for reference.  You can choose to set the effective date to the day after it expires or to another date.  If you choose a date earlier than the expiration date of the existing document, the existing document's effective until date will be reduced.  If you choose a date more than 1 day after the expiration date, there will be a period where there is no effective version of the document. If you choose a current date, the existing document version's effective period will end immediately and that version becomes obsolete. 
    6. The Effective until date controls when the document's effectiveness will end.  You can set this for a time period (e.g., a year) and then later choose to extend this date after periodic review before the expiration.  If a document passes its effective until date, the document will move to an Obsolete status.
  5. Click "Make Effective" to save the metadata.

After adding the document, it will be added to the Controlled Document Management application and will be in an Effective or Future Effective state.  For the documents in Future Effective state, once the Effective on date is reached, the document status will automatically be changed to Effective, and the previous version will be changed to Obsolete.

Learn more about Controlled Document Management by watching a Quick Tip on Egnyte University: Controlled Document Management

 

 

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