This Vault QMS feature allows Admins to configure user actions or entry actions which create a document based on data from a Quality object record. These documents are created from Formatted Output templates, Document Templates, or Reports, and are saved into Vault, allowing complex configurations and data from reports or multiple related records to be brought into the generated document. Documents created by this function inherit Vault Document metadata from the starting record, are added to the Library, and are linked to the record from which they were generated.

Using Quality Document Generation

Users start document generation either by using a configured user action or by causing the object record to change to a state with a configured entry action. Documents generated via entry actions are created by the System user: Information which may be hidden from a user in Vault, but is configured to be part of the template, will be included as visible information in the generated document. Note that while the document generation feature creates content as the System user, the Owner of the content will be set as per the configuration of the action itself, once the content is created.

As Quality document artifacts can include large amounts of data from many records, this operation can take some time to complete. Once generated, the document is linked in a document reference field on the object record. The name of the generated document is the document reference field label plus the quality object record name, for example, “Related Document – QE000001”. Names will follow the configuration specified for the type of document being created, so this filename can be overridden to match your Vault’s naming schemas.

When generating the document, Vault transfers field data for fields with matching names and data types from the originating object record to fields on the newly created document. This transfer matches field names without their extension, for example, __c or __v, prioritizing the standard field (__v) if there is more than one matching field with the same name. Vault will not violate required field configurations when generating documents. When generating the document via supported types of document template, Vault can also transfer data to the document via Merge Field functionality.

Supported Objects

The Quality Document Generation feature supports the following objects:

  • APQR Item
  • Audit
  • Audit Program
  • Batch / Lot Disposition
  • CAPA Action
  • Change Action
  • Extension Request
  • FMEA Risk Assessment
  • Impact Assessment
  • Investigation
  • Issue Escalation
  • Organization
  • Quality Event
  • QMR Item
  • Record Check Result
  • Risk Register
  • SCAR

Configuration Overview

Setting up the following Vault components ensures you can effectively use the Quality Document Generation feature:

  • Configure appropriate document types, set up as desired with lifecycle and workflow configurations appropriate to the types of content you wish to generate, and add the necessary document generation-related fields.
  • Configure appropriate security for your document types. We recommend using Dynamic Access Control and matching or custom sharing rules to ensure appropriate users can see generated documents.
  • Configure the document generation user or entry action, and ensure that the new document will have an appropriately-defined Owner.

Configuring the Document Type

Document generation relies on the use of the Generate Document From Formatted Output, Generate Document From Report, and Generate Document From Document Template actions. These actions cannot execute if there are blank required fields on the selected document type. Ensure that any required document fields are populated via default values or otherwise before generating the document.

Ensure your Quality object configuration has an appropriate document reference field whose value can be set to the generated document upon executing the action.

Configuring the Document Generation Actions

To enable quality document generation, you must make the action available as a user action or add it as part of an automated process by configuring it as an entry action in your object lifecycle. They are available for configuration in any state on the applicable objects’ lifecycles.

As Quality document artifacts can include large amounts of data from many records, this operation can take some time to complete. Carefully consider where in your processes’ lifecycles to invoke or allow these actions.

While the configured action automatically determines a document Owner, you can use Dynamic Access Control to grant access to other roles as necessary. We encourage planning and testing to ensure that the actions configured for generating these documents perform as expected.

Configuring the Generate Document from Formatted Output Action

To configure this action:

  1. In the User Actions or Entry Actions section of the applicable object lifecycle state details page, click Edit.
  2. Select Always or Perform with conditions as appropriate for your process.
  3. Select the Generate Document From Formatted Output action from the drop-down.
  4. Select a Document Type. You can choose from any document type in your vault. During initial setup, it may be helpful to select a simple document type with few or no required fields for testing purposes.
  5. Select the Document Lifecycle for the document type.
  6. Select an Object Reference Field on Document. After the action executes, Vault populates this field with a link back to the originating record.
  7. If configuring the user action, select from the Available Formatted Outputs to use when generating the document. You can select from any formatted output template that is associated with this object. Consider using the Perform with conditions option to limit the availability of a given template to its appropriate object type.
  8. If configuring the entry action select a formatted output from the Template drop-down.
  9. Optional: If configuring the user action, select a Default Formatted Output. When a user performs the action, this output is the default template in the dialog.
  10. Select a Document Reference Field. The selection is limited to outbound document reference fields available on the lifecycle’s object. After the action executes, this field is populated with a link to the new document.
  11. In the Populate Owner From drop-down, select either From User Field or From Quality Team Role. See details below.
  12. If configuring the user action, enter an Action Label.
  13. Click Save.

Configuring the Generate Document from Document Template Action

To configure this action:

  1. In the User Actions or Entry Actions section of the applicable object lifecycle state details page, click Edit.
  2. Select Always or Perform with conditions as appropriate for your process.
  3. Select the Generate Document From Document Template action from the drop-down.
  4. Select a Document Type. You can choose from any document type in your Vault. During initial setup, it may be helpful to select a simple document type with few or no required fields for testing purposes.
  5. Select the Document Lifecycle for the document type.
  6. Select an Object Reference Field on Document. After the action executes, Vault populates this field with a link back to the originating record.
  7. If configuring the user action, select from the Available Document Templates to use when generating the document. You can select from any document template that is associated with this document type.
  8. If configuring the entry action, select a Document Template from the drop-down.
  9. Optional: If configuring the user action, select a Default Document Template. When a user performs the action, this template is the default template in the dialog.
  10. Select a Document Reference Field. The selection is limited to outbound document reference fields available on the lifecycle’s object. After the action executes, this field is populated with a link to the new document.
  11. In the Populate Owner From drop-down, select either From User Field or From Quality Team Role. See details below.
  12. If configuring the user action, enter an Action Label.
  13. Click Save.

Configuring the Generate Document from Report Action

  1. In the User Actions section of the applicable object lifecycle state details page, click Edit.
  2. Select Always or Perform with conditions as appropriate for your process.
  3. Select Generate Document From Report from the drop-down.
  4. Select a Document Type. You can choose from any document type in your Vault. During initial setup, it may be helpful to select a simple document type with few or no required fields for testing purposes.
  5. Select the Document Lifecycle for the document type.
  6. Select an Object Reference Field on Document. After the action executes, Vault populates this field with a link back to the originating record.
  7. Select your Report Type from the drop-down.
  8. Select an Available Report view from the drop-down.
  9. Optional: Select a Default Report. When a user performs the action, this output is the default template in the dialog.
  10. Select a format to export to from the Report Export Type drop-down. Choose from CSV, Excel, Excel template, or PDF.
  11. Select a Document Reference Field. The selection is limited to outbound document reference fields available on the lifecycle’s object. After the action executes, this field is populated with a link to the new document.
  12. In the Populate Owner From drop-down, select either From User Field or From Quality Team Role. See details below.
  13. Enter an Action Label.
  14. Click Save.

Populating the Document Owner

The Populate Owner From drop-down determines which user to place in the Owner role on the generated document once it is created. Select either From User Field or From Quality Team Role. The From User Field option adds a user from the selected User object reference field on the object. Note that to use this option, a User reference field must be configured on the object. Once configured, this User reference field can be set as a Linked Field to a Quality Team Role with a max of one (1) user, or populated manually

The From Quality Team Role option populates the Owner role with a Quality Team member from the selected Quality Team and Quality Team Role. Note that the Quality Teams and roles presented allow selection from any Team associated to any type of this object. Choose only the team that is in use by the type of record for which this action will be applicable. Only Quality Team Roles with a maximum of one (1) user may be used for this purpose.

About Document Generation Actions After Vault Provisioning by Cloning

If Vault Product Operations clones your Vault after you have configured the Generate Document From Document Template action in it, you may need to reconfigure the action in the new Vault as the nature of the document templates may have changed.