Click the blue “Add New File Button” and name the document and select the document category. Please keep in mind, file names must be unique. Once you’ve entered the information, click “Create”.
Enter the details for the document. If applicable, you can manage the authors of the document by clicking the “Manage Authors” button. You may choose up to 3 authors.
To upload the file, click the “Upload Revision” button. Browse to the location of the document you want to upload. The file upload has no size limit. You may also upload any type of file you would like.
Under the Document Security field select one of the following options:
- Users Can Download Original File - all users assigned to this document or with permission to view the document will be able to download a copy of the original document. Please note all Super Users and Authors will always have access to the original file.
- Users Can Download an Unrestricted PDF - all users assigned to this document or with permission to view the document will be able to download a PDF version.
- Users Can Only View Document - all users assigned to this document or with permission to view the document will only be able to access a read only version within the system. They will not be able to right click, save, or print the document.
- Authorized Users Can Issue Controlled Copies – authorized users will be able to issue a controlled copy of the document. If users are assigned to or given access to this document but not given the authorization to issue a controlled copy they will only be able to view the document within the system. Lastly, the document category security setting must be set to “Authorized Users Can Issue Controlled Copies” for the individual document to allow this feature to accessed.
Select the effective date of the document. If all signatures are collected approving the document before the effective date, the document will remain in an approved state until the effective date arrives. At that time it will convert to an effective state.
Choose if you’d like to have training records automatically created for authors and workflow participants who will sign and approve the document.
Next choose how often you’d like assigned users to retrain on the document. You may choose that you never want users to retrain or a time period between 3 months and 60 months. Users assigned to train on this document will automatically be notified to retrain at the specified interval.
Document Review Interval works the same way as the User Retraining Interval. The author(s) of the document will be notified at this interval of time to review the document. Choose an interval of time from the dropdown list.
The 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. Remember this is searchable text and will appear in the table if the respective column is included.
If they’ve been added, you can also enter additional information in the custom fields. If you would like to create a bi-directional link to another item in the software you can click the Add Link button to choose a category and search for the specific item to link. This can be another document, issue, CAPA, event, audit, etc.
If you’d like to add a Training Challenge Question for users to answer before being able to complete their training, click the Training subtab then click the Add Question button. You will choose either multiple choice or true/false question type and enter your details. You may add as many questions as you’d like. You can set a minimum pass rate if you’d like by clicking the blue hyperlink that “Trainees must answer at least 100% to complete training” and update the percentage.
Once all of that is done, you have one of two options - launch approval workflow or launch draft review.
If the document is the final version you will launch the approval workflow to get the document signed and bring the document from Draft status to an approved or effective document. Click the button that says “Launch Approval Workflow”. Your preset workflow settings 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. By default all Authors will need to sign the document. The predefined workflow settings are determined by the category to which you are adding the document. 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.
If the document draft needs to be approved before bringing it to an effective or approved state within the software, you will click the “Launch Draft Review” button. Select from the list of names who you would like to review this draft. You can select multiple people, however it will progress in a linear fashion from the first name to the last. 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.