Working with Extensible Controlled Copies (QualityDocs)

QualityDocs users often require a way to track specific content copies outside of Vault, or prepare copies with specific overlays for specialized use. QualityDocs Vaults provide special user actions to assist with these use cases, supporting download, distribution, and reconciliation of controlled copies.

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

How Vault Manages Extensible Controlled Copies

With object-based Extensible Controlled Copies, Vault collects controlled copy information via configurable object records instead of through a static form. Capturing controlled copy information in object records allows for much more robust data collection, security, processes, and reporting options.

When you download a controlled copy, Vault opens the form to create a new Controlled Copy User Input record within the dialog. In this dialog, you can enter data about the controlled copy request in the fields configured by your Admin. When you submit the controlled copy request, Vault generates a ZIP file containing your requested controlled copy and an associated manifest file.

For each controlled copy, Vault also creates an associated Controlled Copy Trace record and copies field data on the Controlled Copy User Input record to each Controlled Copy Trace record. You’ll see a banner alerting you that the job is in progress, and you’ll receive a Vault notification when the ZIP file is ready to download.

See details below about potential errors you may encounter while downloading a controlled copy.

About Controlled Copy Recall & Reconciliation

The Controlled Copy Trace object lifecycle is highly configurable to meet your organization’s controlled copy process requirements. Veeva-recommended configurations for managing the recall or reconciliation process include:

• Automatic controlled copy recall when a document reaches a certain state, such as Superseded or Obsolete. This configuration additionally supports manual recall.
• Manual reconciliation of up to 100 records at a time via the Controlled Copies for Reconciliation page. This process can be further expedited with the page’s scanning mode, which allows you to scan a document’s QR or barcode and quickly locate its related Controlled Copy Trace record.

These options can be configured separately or together.

Downloading Controlled Copies

To download a controlled copy:

1. From the document’s All Actions menu, select a controlled copy action. These actions vary based on your organization’s configuration and may not contain “controlled copy” in the name.
2. Vault opens the Controlled Copy User Input dialog. The dialog title and fields that appear here will vary depending on your Admin’s configuration.
3. Fill in fields as needed.
4. Click Continue. Vault asynchronously generates a ZIP file containing your requested copies. The ZIP file also includes a manifest PDF file listing the copy type, document name, and the requestor’s name, followed by all user-entered fields in alphabetical order. You can download the file from your Notifications page.

Downloading Controlled Copies in Bulk

To request controlled copies from multiple documents via a bulk action, see Using Bulk Document Actions.

Reconciling Controlled Copies in Bulk

You can manually recall up to 100 controlled copies at a time via the Controlled Copies for Reconciliation tab. When a document includes a QR code or barcode, this specialized page’s scanning mode allows you to quickly locate its related Controlled Copy Trace record.

1. Navigate to the Controlled Copies for Reconciliation tab. This tab may appear with a different label depending on your Vault’s configuration.
2. Vault displays all active Controlled Copy Trace records.
   • Use the page’s search bar or apply filters to locate the record(s) you’d like to recall, then click the left-hand checkbox next to each record.
   • When a document includes a QR code or barcode, click Select via scan to enter scanning mode. Once you scan the code, Vault populates and selects the Controlled Copy Trace record, along with any records you manually selected.
3. Click Continue.
4. In the Start Workflow dialog, select the applicable multi-record object workflow (for example, “Controlled Copy: Recall”), then click Continue.
5. If required, populate any required fields (for example, Reconciliation Notes), then click Start.

Vault returns to the default Controlled Copies for Reconciliation page and displays the Workflow you initiated for each Controlled Copy Trace record. Once the workflow is complete and the record enters a state in which it becomes inactive (for example, “Recall Confirmed”), it is no longer available for selection on the page.

About Automatic Controlled Copy Recall

The Controlled Copy Trace object lifecycle is highly configurable to meet your organization’s controlled copy process requirements. The Veeva-recommended configuration allows for both automatic and manual recall such that:

• When a controlled copy is Superseded or made Obsolete, Vault automatically moves Controlled Copy Trace records to the In Recall state and initiates a workflow for the requesting user to reconcile the document which is no longer in use.
  • Once complete, Vault moves the record to the Recall Confirmed state, where it becomes inactive.
  • As with many automated workflow configurations, Vault issues a single workflow per Controlled Copy Trace record during these operations, meaning a single document version with, for example, five related Controlled Copy Trace records results in five workflows for the requesting user(s) to reconcile. The Controlled Copies for Reconciliation tab and its related configuration can expedite this process by allowing a single workflow to process multiple Controlled Copy Trace records.
• While a Controlled Copy Trace record is in its In Recall state, users can execute the Confirm Reconciliation action to manually recall that record. This state also includes an action to Revert to Active, where Vault moves the record back to the Active in Use state.

Reporting

Legacy controlled copy Distribution with Document-type reports are not applicable for Extensible Controlled Copies. To report on Extensible Controlled Copy data, configure a report referencing Controlled Copy Trace object records.

Errors & Limitations

In some cases, Vault may not be able to download controlled copies:

• If there is a configuration error between the Controlled Copy User Input and the Controlled Copy Trace object types or records, Vault cannot successfully download controlled copies.
• In most cases, Vault creates the Controlled Copy Trace record even if there is an error downloading a copy or preparing the manifest file. In this case, Vault does not set the checkbox in the Released from Vault field on the Controlled Copy Trace record.
• Vault reports any errors encountered when downloading a controlled copy in the delivered manifest file.
• During the controlled copy bulk action, if Vault cannot create the Controlled Copy User Input record, Vault will inform you on the Confirmation page of the bulk action wizard.
• Vault cannot download Extensible Controlled Copies for documents with password-protected source files.

Related Permissions

See Extensible Controlled Copy Configuration for the permissions required to use this feature.