Using the Material ID document field, Vault can track the document number and revision in an automatically generated unique ID number on the Promotional Material. Users can easily identify the steady state version for audit and compliance purposes and for submissions to health authorities. Vault updates the Material ID each time the document moves from a Steady State to Draft, often at the same time as Vault upversions the document, such as from version 2.0 to 2.1. This improves compliance and tracking for content update and reuse.

The Material ID field is beneficial for both eCTD and non-eCTD submissions.

To use the Material ID field, you must configure the Material ID, Revision, and Update fields on the Material doc type. If you are generating eCTD Compliance Packages, you’ll also need to add the Promotional Material ID field to the Clean Material document type.

To configure the Update field:

  1. Navigate to Admin > Configuration > Document Fields.
  2. Under Field Location, select Material.
  3. Click Add and select New Field to create a custom document field.
  4. Configure the new document field as follows:
    • Field type: Yes/No
    • Label: Update
    • Set the Do not copy this field during Make a Copy checkbox
    • Display Section: Submission Details
    • Default Value: No
    • Help Content: Update Material ID and Revision fields on next state change if the Update field = Yes
  5. Click Save.
  6. Under Material, select the new Update field.
  7. Click the Security Overrides tab and set the Default Security to Read Only.

After creating the Update field, configure document fields and the Material lifecycle:

  1. Navigate to Configuration > Document Fields
  2. Under Field Location, select your Promotional Material document type. By default, this is Material.
  3. Click Add and select Existing Shared Field.
  4. Add the following fields:
    • Material ID
    • Update
    • Revision
  5. Repeat steps 2 – 4 to add the Promotional Material ID field to the Clean Material document subtype. Note that you should not add the Material ID, Update and Revision field to the Clean Material document type.

If you are using the PromoMats & RIM Vault connection, you’ll also need to perform the following steps:

  1. Navigate to Configuration > Document Fields.
  2. Under Field Location, select eCTD Submission Ready Documents, then expand Submission Ready Copies.
  3. Select Annotated Material.
  4. Click Add and select Existing Shared Field.
  5. Select Promotional Material ID.
  6. Click OK.
  7. Repeat steps 3 – 6 with the following document classifications: Annotated Label, Annotated Reference, and Clean Material.

Next, add event actions to the Material lifecycle:

  1. Navigate to Configuration > Document Lifecycles > Material > Event Actions.
  2. Open Create Document event and click Edit to add the following event actions:
    • Always update document field Revision, set to value 1.
    • Always update document field Material ID to Document.document_number__v & "-1".
  3. Click Save and return to the Event Actions tab.
  4. Open the Create Draft event and click Edit to add the following event actions:
    • If document field Update equals Yes, perform actions** update document field** Revision set value to If(IsBlank(Document.revision__v), 1, Document.revision__v + 1).
    • If document field Update equals Yes, perform actions** update document field** Material ID set value to Document.document_number__v & "-" & Text(Document.revision__v, "#").
    • If document field Update equals Yes, perform actions update document field Update and set value to False.
  5. Click Save and return to the Event Actions tab.
  6. Open the Create Copy event and click Edit to add the following event actions:
    • Always update document field Revision, set to value 1.
    • Always update document field Material ID to Document.document_number__v & "-1".
  7. Click Save.

To update the Material lifecycle:

  1. Navigate to Configuration > Document Lifecycles > Material > States.
  2. Open the Draft state.
  3. Click the Entry Actions tab and click Edit to add the following new rule:
    • Perform with conditions
    • If Update equals Yes, Update Revision and Material ID and Set field using formula Update equals false.
  4. Click Save and return to the States tab.
  5. Open the steady state. By default, this is the Approved for Distribution state.
  6. Add the following rule:
    • Always
    • Set field using formula Update equals true.
  7. Click Save.

Finally, if you’re creating eCTD Compliance Packages, update the Correspondence Letter, XML elements, and the lifecycle your Promotional Material is using. By default, Promotional Materials are included in the Material lifecycle.

To update the Correspondence Letter:

  1. Open the Correspondence Letter template document.
  2. In the Material ID section, add the following Promotional Material ID token to allow Vault to populate the unique ID number: ${vault:document_promotional_material_information__vr.documents__vr.promotional_material_id__v}.
  3. Navigate to Business Admin > Documents & Binder > eCTD Submission Ready Documents > Correspondence Letter.
  4. Click Edit.
  5. Click Upload File and select the edited Correspondence Letter template file.
  6. Click Save.

To update the XML elements:

  1. Navigate to Business Admin > XML Elements.
  2. Open the Input 7.d Material ID Code record and click Edit.
  3. Enter DocInBinder.promotional_material_id__v in the Formula field.
  4. Click Save.
  5. Repeat steps 2 – 5 for the Input: Document Row: Doc Number Input record.

Promotional Material Document Name and Description Fields

You can configure eCTD Compliance Packages to use the Promotional Material Document Name and Description fields. You can add these fields to the Correspondence Letter and 2253 and Supplementary Forms.

You’ll first need to add the fields to several document types:

  1. Navigate to Configuration > Document Fields.
  2. Under Field Location, select eCTD Submission Ready Documents, then expand Submission Ready Copies.
  3. Select Annotated Material.
  4. Click Add and select Existing Shared Field.
  5. Select Promotional Material Document Name.
  6. Click OK.
  7. Repeat steps 3 – 6 with the following document classifications: Annotated Label, Annotated Reference, and Clean Material.

Next, you’ll need to update XML elements for the 2253 and Supplementary Forms:

  1. Navigate to Business Admin > XML Elements.
  2. Click 7. e. Material Description.
  3. Click Edit.
  4. In the Formula field, enter DocInBinder.promotional_material_doc_name__v.
  5. Click Save.
  6. Return to Business Admin > XML Elements.
  7. Click Document Row: Document Name Input.
  8. Click Edit.
  9. In the Formula field, enter DocInBinder.promotional_material_doc_name__v.

Finally, you’ll need to replace the Material Description formula in the Correspondence Letter template with ${vault:document_promotional_material_information__vr.documents__vr.promotional_material_doc_name__v}.

FAQ

Can I hide the Update field?

No. If you hide the Update field, the feature will not work.

Can I change the Material ID or Revision values?

By default, these fields are set to Read Only. We recommend keeping Material ID and Revision as Read Only fields to ensure the values remain unique. However, Admins can make these fields Editable if necessary. Note that editing these fields may result in ID numbers that are non-sequential or non-unique. For example, if a user manually updates a document’s Material ID field from US-23456-2 to US-23456-7, when the entry or event action occurs, Vault will automatically overwrite the edited Material ID field and update both the Revision and Material ID field to 3, resulting in an ID number of US-23456-3.

Will configuring this feature affect documents created previously?

Once the feature is configured, the Revision and Material ID values on pre existing documents are blank. The fields are populated by Vault when the configured entry actions or event actions occur.

If I reclassify a document to a document type with the Material ID and Revision fields, are the values updated immediately?

No. The Material ID and Revision fields are only populated when the configured entry actions or event actions occur.