Configuring Extensible Controlled Copy (Document Control)

QualityOne Vaults allow you to track specific content copies outside of Vault, or prepare copies with specific overlays for specialized use. The Extensible Controlled Copy feature provides special objects and fields to support the preparation, download, and distribution of controlled copies.

When downloaded, Vault assigns each controlled copy a unique identification number and creates a Controlled Copy Trace object record, allowing users to track the status of those copies outside of the Vault. With a dedicated lifecycle for these object records, users can manage both the distribution and the reconciliation of these copies according to their organization’s needs. You may also configure and apply specialized overlays or choose to attach signature pages on the content when users download controlled copies. Depending on the document lifecycle state, there may be zero (0), one (1), or many controlled copy actions, for example, Request Laboratory Reference Copy and Request Facility Posting Copy.

About Extensible Controlled Copy Downloads

When a user selects the Download Controlled Copy user action, Vault opens the Create Record page for the Controlled Copy User Input object in the dialog. Users enter data in the fields you configured. When a user completes the request to download the controlled copy, Vault generates the appropriate documents in a ZIP file and sends the requesting user a notification with a link to download the file.

Vault also processes the Controlled Copy User Input record, populates any system-managed fields, and automatically creates associated Controlled Copy Trace records for each document copy requested, copying data from any user-entered fields on the Controlled Copy User Input record into identical fields on the Controlled Copy Trace record. Vault automatically sets the Released from Vault field checkbox on the Controlled Copy Trace record after a successful document download. Vault does not set this if an error occurred while attempting to download the controlled copy. You can then use the Controlled Copy Trace record to view, report on, and reconcile controlled copy data.

Extensible Controlled Copy Objects

QualityOne uses the following objects to support Extensible Controlled Copy:

• Controlled Copy User Input (controlled_copy_user_input__v): This object captures information from the user who requests to download a controlled copy. Your organization can add, edit, or remove fields to customize the data collected. Vault creates these object records when a user selects a controlled copy user action, and then processes these to generate Controlled Copy Trace records and download the requested content for the user. This object supports object types with both standard and custom fields, and you can adjust object page layouts to include all relevant fields for data capture.
• Controlled Copy Trace (controlled_copy_trace__v): This object houses trace records for all controlled copy files generated for your Vault. Controlled Copy Trace supports object types with both standard and custom fields. Vault creates each record and auto-populates many fields when the user completes the controlled copy request. Users cannot manually create or delete Controlled Copy Trace records; only Vault can create these when a user downloads a controlled copy.

Enabling Extensible Controlled Copy

Contact your Veeva Representative to enable Extensible Controlled Copy in your Vault. If you are using legacy controlled copies, enabling Extensible Controlled Copy effectively replaces all legacy document-based controlled copy functionality and disables all existing controlled copy actions and configurations, with the exception of the Distribution report. The report allows you to finish reconciling legacy controlled copies while you transition to Extensible Controlled Copies, but prevents you from generating new legacy controlled copies or adding new entries to the Distribution report.

Extensible Controlled Copy Migration from Legacy

If your Vault uses legacy controlled copy and is transitioning to Extensible Controlled Copy, before turning on the feature for QualityOne, contact your Veeva Representative to discuss the best approach to migrate your Vault from the legacy controlled copy configuration to the new Extensible Controlled Copy model.

Configuration Overview

If you choose not to work with your Veeva Representative to configure Extensible Controlled Copy initially or to migrate from legacy controlled copy configurations in your Vault, you must complete the following steps:

1. Configure identical object types on the Controlled Copy User Input and Controlled Copy Trace objects for any type of controlled copy you may need. You must configure page layouts for these object types too, but they do not need to be identical.
2. Configure the Controlled Copy Trace lifecycle to allow Vault to manage and track downloaded controlled copies.
3. Configure or update user and entry actions on the applicable document lifecycles to allow users to download controlled copies and automate the process of recalling controlled copies.
4. Configure Atomic Security on the Controlled Copy Trace object fields to prevent users from accidentally updating important fields. Vault does not automatically apply security to fields on the Controlled Copy Trace object.
5. If applicable, update any overlays that supported legacy controlled copies to reference new Extensible Controlled Copy tokens.
6. Optional: Create a custom tab so users can easily access controlled copies.
7. Configure user permissions.
8. If applicable, update any permission sets that supported legacy controlled copies to grant appropriate users Create permission on any Controlled Copy User Input object types and Read permission on any Controlled Copy Trace object types.

Configuring Controlled Copy Objects & Object Types

In order for users to download controlled copies, you must configure matching object types on the Controlled Copy User Input and Controlled Copy Trace objects. The two (2) object types must include identical Labels, Plural Labels, and Names (public keys). You can create multiple object types for the various types of controlled copies needed in your Vault.

The fields you select or create when configuring these object types define the fields users populate when downloading a controlled copy. For example, we recommend creating fields on each object to capture details such as Reason or Justification, Requested For, and Audience Details.

About Controlled Copy Object Fields

In order for Vault to capture data and correctly populate fields on the Controlled Copy Trace record when a user downloads a controlled copy, you must create identical fields on both the Controlled Copy User Input and Controlled Copy Trace object types. The Controlled Copy Trace object type can include fields that are not on the Controlled Copy User Input object type, although there is no way for a user to populate these.

If field configurations don’t match across the Controlled Copy Trace and Controlled Copy User Input objects, Vault can’t create the Controlled Copy Trace record when a user downloads a controlled copy. Common errors include:

• A field that is required on the Controlled Copy Trace object does not exist or is not required on the Controlled Copy User Input object.
• Corresponding fields across the Controlled Copy Trace and Controlled Copy User Input objects have different field types.
• Corresponding text fields across the Controlled Copy Trace and Controlled Copy User Input objects do not have the same Maximum Length.
• Corresponding number fields across the Controlled Copy Trace and Controlled Copy User Input objects do not have the same Minimum value and Maximum value.
• Corresponding fields across the Controlled Copy Trace and Controlled Copy User Input objects have different Dynamic Reference Constraints configured.

For example, you could make an Intended Use field required on the Controlled Copy User Input object type, but optional on the Controlled Copy Trace object type. Vault automatically copies the field value to the Controlled Copy Trace object. However, if you made the Intended Use field optional on the Controlled Copy User Input object type but required on the Controlled Copy Trace object type, a user downloading a controlled copy could forego entering data in the Intended Use field, and Vault could not create the associated Controlled Copy Trace record.

Controlled Copy User Input Object Required Fields

You must add the Vault Document (vault_document__v) field on all Controlled Copy User Input object types. You should not add this field to the Controlled Copy User Input object page layouts, as it could cause errors when users request controlled copies from multiple documents via bulk action.

Controlled Copy Trace Object Required Fields

You must add the following fields on all Controlled Copy Trace object types, although we do not recommend adding these fields to Controlled Copy Trace object page layouts:

• Autonumber Prefix (autonumber_prefix__v)
• Autonumber Prefix Pattern (autonumber_prefix_pattern__v)
• Migrated (migrated__v)
• Vault Document (vault_document__v)

Object Page Layouts

After you set up the Controlled Copy User Input and Controlled Copy Trace object types, you can configure the object page layout for each type to define the fields that the user sees and populates in the Controlled Copy User Input dialog when downloading a controlled copy, and in the Controlled Copy Trace object record detail page.

Controlled Copy Trace Lifecycle

This lifecycle is associated with the Controlled Copy Trace object and allows organizations to manage and track Controlled Copy Trace records representing documents removed from the Vault. The Controlled Copy Trace lifecycle includes the following states by default:

• Active in Use: This controlled copy is currently outside of the Vault.
• In Recall: This controlled copy is currently in use outside of the Vault, but a recall exists to discontinue it.
• Recall Confirmed: This controlled copy is removed from use outside of the Vault.

You may update these states, configure Atomic Security, or utilize various object lifecycle and workflow actions (such as automatic recall) to create a robust process that represents how your organization accounts for content after it has left your Vault.

Configuring Controlled Copy Actions

The Controlled Copy user and entry actions allow users to download controlled copies and automatically recall the controlled copies of documents that enter an obsolete or superseded state while their controlled copies are in circulation.

Configure your Vault to include the following actions for Controlled Copy:

• Download Controlled Copy user action
• Recall Controlled Copy entry action

Configuring the Download Controlled Copy Action

To allow users to download controlled copies, you’ll need to configure a user action on the applicable document lifecycle state. The user action type for Extensible Controlled Copy is Download Controlled Copy. There are several fields available for configuration:

• Controlled Copy Type: Indicates which controlled copy object type the user is requesting. Controlled Copy User Input object types that do not have a matching Controlled Copy Trace object type do not appear in the drop-down.
• Autonumber Prefix: Indicates the token pattern Vault uses for autonumbering Controlled Copy Trace records of the selected type. Vault includes a default pattern, or you can create your own.
• Overlay: Indicates the overlay templates Vault applies to the content when a user downloads a controlled copy. This selection overrides the lifecycle state-based overlay selection. As a best practice, we recommend selecting a single overlay. However, you can select up to five (5) templates, which Vault applies together.
• Include signature page: Specifies whether or not Vault includes a signature page with the content when a user downloads a controlled copy. If a signature page exists, Vault applies it for that specific document. If not selected, the controlled copy omits the signature page, regardless of whether there are signatures applied.

When configuring new controlled copy actions, be sure to check that the lifecycle state security settings grant the Distribute Controlled Copy permission to users with appropriate document lifecycle roles. For example, no user could access a Download Controlled Copy action on the Approved document lifecycle state if that state’s security settings do not grant the appropriate permission to at least one (1) document lifecycle role.

Autonumber Prefix

Vault applies the autonumber prefix to Controlled Copy Trace records. You can include tokens in your autonumber prefix that reference fields on the Controlled Copy User Input object using the syntax: ${VCC__fieldname__v}. For example, the token ${VCC__name__v} references the name of the Controlled Copy User Input record. Vault also supports the following legacy controlled copy tokens in Vaults with Extensible Controlled Copy enabled:

• ${docNumber}: Document Number
• ${docMajor}: Document Major Version Number
• ${docMinor}: Document Minor Version Number

We recommend that you replace “CC” in the default Controlled Copy autonumber prefix format with a value that corresponds to the menu label, for example, FPC-${docNumber}-${docMajor}-${docMinor}- for the menu label Request Facility Posting Copy. If you use the same number format, for example, CC-{####}, for two (2) separate user actions, they share the numbering value so that it is impossible to create two (2) controlled copies with exactly the same copy number.

Configuring the Recall Controlled Copy Action

When a document is superseded or made obsolete while its controlled copies are in circulation, your organization may require a recall process to harmonize the controlled copies.

You can configure the Recall Controlled Copies entry action on a document lifecycle state to automatically place Controlled Copy Trace object records associated with an Obsolete or Superseded document into an In Recall state. You can also configure the state change to trigger a workflow for the appropriate personnel to start a recall process.

Configuring the Recall Controlled Copy action involves the following steps:

• Configure the Recall Controlled Copies entry action to ensure that all related Controlled Copy Trace records enter an In Recall state when their associated document enters an Obsolete or Superseded state.
• Configure an auto-start workflow on the In Recall state to automatically notify key personnel and include participants in a recall workflow.

Configuring the Recall Controlled Copies Entry Action

To configure the Recall Controlled Copies entry action:

1. Navigate to Admin > Configuration > Object Lifecycles > Controlled Copy Trace Lifecycle > State Types and add states to state types in the Controlled Copy Trace object lifecycle.
   • For the Controlled Copy In Use state type, assign the Active In Use state for copies issued to locations outside Vault, such as a manufacturing floor. Your organization’s labels for states may differ.
   • For the Controlled Copy In Recall state type, assign the In Recall state for issued copies that need to complete a recall process.
2. Add the Recall Controlled Copies entry action to a state in a document lifecycle:
   1. Navigate to Admin > Document Lifecycles > [Lifecycle] > States > Obsolete or Superseded state > Entry Actions and click Edit.
   2. Click Create Entry Action.
   3. Select Always or Perform with conditions as appropriate for your process.
   4. Select the Recall Controlled Copies action from the drop-down.
   5. Use the Object Type drop-down to specify if the action is available on all Controlled Copy Trace object types or only on certain object types.

After the action runs, you can verify that all in-use controlled copies were successfully recalled by running a report on the Recall System Details field of the Controlled Copy Trace object.

Notifying Participants in a Recall Process

Once you have configured the action, you can create a report to let the appropriate personnel know they need to reconcile the Controlled Copy Trace records.

You can further automate the recall process by configuring an auto-start workflow on the In Recall state and assigning a recall process task to a chosen role on the Controlled Copy Trace record. You can determine how Vault populates this role in multiple ways:

• Add the Add User to Role entry action to the In Recall state of the Controlled Copy Trace object. For this option, ensure you have Dynamic Access Control enabled for the Controlled Copy Trace object. This entry action must run before the Start Workflow entry action. To configure, do the following:
  1. Navigate to the In Recall state on the Controlled Copy Trace object lifecycle.
  2. Click Edit on the Entry Actions section.
  3. Click Create Entry Action.
  4. Select Always or Perform with conditions as appropriate for your process.
  5. Select the Add User to Role action from the drop-down.
  6. Specify the User Field and Role from the drop-down. Vault adds the value of the selected User Field (for instance, “Requested By”) on the Controlled Copy Trace record to a lifecycle role selected from the Role drop-down.
• Use Custom Sharing Rules or Matching Sharing Rules to populate the role.

Configuring Atomic Security for Extensible Controlled Copy

The Controlled Copy Trace object is intended to be a record of truth for tracking controlled copies after they leave Vault. You are responsible for configuring Atomic Security on all fields representing content that has left the Vault. As a best practice, we recommend applying Atomic Security on all fields, following these general guidelines:

• If Vault copies a field from the Controlled Copy User Input record to the Controlled Copy Trace record, Atomic Security for that field should be Read Only for all roles in all states of the Controlled Copy Trace Lifecycle.
• If the field is unique to the Controlled Copy Trace object and represents information captured during the reconciliation process or another custom process in your Vault, you can apply Atomic Security at your discretion based on your organization’s needs.

Configuring Overlays

With Extensible Controlled Copy, you can include tokens that reference Controlled Copy Trace object fields in overlay templates.

Standard Overlay Templates

In overlay template override, Vault supports the following token syntax for Controlled Copy Trace object reference fields: ${VCC__fieldname__v}. For example, to reference the record’s name, your token would be: ${VCC__name__v}.

You can select all Controlled Copy Trace object fields as tokens with the exception of system fields, such as Status, and long text fields. Vault validates your tokens when you save your overlay template.

Advanced Overlay Overrides

When creating an XFA PDF file to use as an overlay template override, you can include tokens referencing the Controlled Copy Trace object. You must use the “Text Field” type to add a Vault field to your XFA PDF, regardless of the field’s type in your Vault.

For example, syntax for a token referencing the Controlled Copy Trace object would be: VCC__fieldname__v. To reference the record’s name in your XFA PDF file, you would include the token: VCC__name__v.

All Controlled Copy Trace object fields are supported as tokens with the exception of long text fields. Vault validates your XFA PDF file at upload.

Configuring a Custom Tab

You can configure a custom tab for the Controlled Copy User Input object so users can easily access and create records to request controlled copy downloads.

Configuring User Permissions

You must ensure users have the appropriate read and create permissions to access the appropriate objects and object fields in addition to the permissions outlined below:

• For the Controlled Copy User Input object: Read and Create permission.
• For the Controlled Copy Trace object: Read permission.
• For the Document Role, grant the permission Distribute Controlled Copy to allow users the ability to access user actions from the document All Actions menu to download controlled copies. This permission also controls the ability to download controlled copies in bulk.

Related Permissions

You can complete all the steps in this article with the standard System Administrator or Vault Owner security profile. If your Vault uses custom security profiles, your profile must grant the following permissions:

Type	Permission	Controls
Security Profile	Admin: Configuration: Document Lifecycle: Edit	Ability to configure document lifecycles and the Download Controlled Copy user action on document lifecycle states, associate an overlay template with a lifecycle state.
Security Profile	Objects: Controlled Copy Trace (all object types): Read, Edit, Create	Ability to make changes to Controlled Copy Trace records.
Security Profile	Objects: Controlled Copy User Input (all object types): Read, Edit, Create	Ability to make changes to Controlled Copy User Input records.