Note: Users will need the permission: "Can Add New Controlled Files" and also the permission "Can Add Files" at the document category level. 

1. Log into ZenQMS, click on the Documents Module:

docs

2. Click on the drop-down labeled "My Documents Dashboard" and select "Documents: Full Table":

docs

3. Click on  Screen_Shot_2018-07-06_at_2.39.20_PM.png

4. Choose a unique name for the document and choose the category that it will be under:

Screen_Shot_2018-07-06_at_2.40.08_PM.png

5. Next, you can select certain settings for this document, though most are set at the document category level:

Authors - you can add up to three authors by clicking the "manage authors" button

Upload Revision - click the Screen_Shot_2018-07-09_at_9.32.48_AM.png to upload the document file, we recommend that the file that you upload has a top margin of 2 inches and side margins of .55 inches if you are using the ZenQMS generated headers. If you are not using the ZenQMS generated headers, files need to have a top margin of 1.50 inches and side margins of .55 inches.  Click here to find the file types that can be uploaded.

 

DETAILS

  • Name (must be unique) - will already be populated
  • Category - will already be populated
  • Document Security - you will be able to choose from 4 different settings:
    • Users Can Download a Unrestricted PDF - selecting this option allows users to download and view a pdf version of your original document. Users will be able to view the same pdf version within ZenQMS as well. They will not be able to download the original version of the document.
    • Users Can Download Original File - selecting this option allows users to download the original version of the document. They will also be able to download and view a pdf version of your original file. Users will be able to view the same pdf version within ZenQMS as well.
    • Users Can Only View Document - selecting this option only allows users to view this document in a pdf format within ZenQMS. They cannot download any version of this document. 
    • Authorized Users Can Issue Controlled Copies - users will only be able to view the document in ZenQMS unless they are given permissions at the document category level to issue controlled copies. See this link for more information: Understanding Controlled Copies
  • Set Effective Date - You have two options to choose from:
    • Based on target date 
    • Based on training % - once the percentage of the assigned training has been completed the document will become effective
  • Choose if you want training records created for authors/workflow participants
  • Choose if you would like users to retrain on the document and how often. The option for the time ranges span from 3-60 months 
  • Choose how often you would like the document to be reviewed by the authors
  • Document Description and Version Comments - boxes are both standard text boxes into which you can type directly or copy and paste. Add a description of the document uploaded and commentary on the version of the document. 
  • You have the ability to the link the document to another item, can be another document, an Issue, CAPA, event, audit, etc.

TRAINING

 

Next, you can either launch the approval process or draft review process:

LAUNCH APPROVAL WORKFLOW

  • When you click on Screen_Shot_2018-07-09_at_9.45.17_AM.png , your preset workflow settings (configured at the document category level) will appear on the next screen. You can add additional steps if necessary by clicking “Add Another Workflow Step” at the bottom of this screen. 
  • To send the document out for Approval, click the green “Launch Workflow” button. As the author, you will enter your username and password to sign immediately. Workflow users will be notified to come into the system to review and sign.

LAUNCH DRAFT REVIEW

  • If the document draft needs to be approved before bringing it to an effective or approved state, click Screen_Shot_2018-07-09_at_9.47.29_AM.png and select from the list of names who you would like to review this draft.
  • Click the green “Launch Workflow” button when you are finished adding the names in the proper order. At anytime you can click on the “Workflows/Signatures” subtab within a document to see where the document is within the approval process and who needs to review and sign next.

 

 

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