Batch Release Overview

Vault Batch Release is an application in the Vault Quality suite used by pharmaceutical companies to review batches for compliance so they can be dispositioned for use and shipment within their supply chain. The Batch Release Execution page facilitates this process by automatically aggregating batch-related information from quality, regulatory, and manufacturing systems so they can be checked in a unified interface to support a disposition decision.

How Batch Release Works

While processes for batch release differ across organizations, the following example takes advantage of the automation described in this article:

• The batch release owner creates a new Batch Disposition record from an existing Batch Disposition Plan.
• From the Batch Release Execution page, the release owner manually completes each Batch Disposition Check once all Batch Disposition Items are complete. If configured by an Admin, Vault automatically closes these checks once all Batch Disposition Items are complete.
• The release owner makes a decision for each Batch Disposition Check and selects whether the check is compliant or not. If all Batch Disposition Items are not closed or the check is found to not be compliant, a justification may be required if the batch is still accepted.
• The release owner can then initiate the Batch Release workflow once all checks are complete. This workflow is configurable.
• Vault assigns the reviewer a workflow task to set a decision for the Batch Disposition. It can be accepted, conditionally accepted, placed on hold, rejected, or reworked. By default, Vault requires the reviewer to provide a justification unless the decision is Accepted and all checks are ready and compliant.
• Vault assigns the approver a workflow task to confirm the release decision, provide a verdict, and provide an eSignature if prompted.
• If the decision is Accepted, then the Batch Disposition record moves to the Closed state. If configured by an Admin, Vault automatically closes all Batch Disposition Checks associated with the disposition.

Batch Release Data Model

The Vault Batch Release data model includes the following core objects:

• Batch Disposition: An evaluation that is created, executed, and closed with a decision for each batch using a configurable workflow. When a batch is activated or enters a specified state, this triggers the creation of Batch Dispositions with all necessary Batch Disposition Checks and Batch Disposition Items as specified by its plan. You can create multiple Batch Disposition Plans to execute when multiple usage decisions are needed, for example, by market.
• Batch Disposition Plan: A plan that is designed, revised, and approved by business administrators and quality managers with all specified required checks needed for a given material and its intended market or usage so that Batch Dispositions can be created from them for every batch of the specified material type. Plans will also define the owner and default due date for the Batch Disposition.
• Batch Disposition Check: A logical unit of work that needs to be completed before a usage decision is made for a disposition. Batch Disposition Checks group similar Batch Disposition Items together that support the decision, such as batch documents, test results, and quality events. When all checks are complete, the disposition can be automatically accepted. There are three (3) types of Batch Disposition Checks:
  • Quality Event: Monitors the state of Deviations, Change Controls, Lab Investigations, and Complaints related to the Batch.
  • Document: Monitors the state of a document that was automatically generated from a document template. Checks can also reference a document type which will generate a Batch Disposition Item for every document created of that type that references the Batch.
  • Input Batch Dispositions: Monitors the state of all Batch Dispositions for batches that were consumed to create this batch.
• Batch Disposition Check Requirement: A reusable requirement that is related to plans that are configured to check a requirement for a Batch Disposition. There are three (3) types of Batch Disposition Check Requirements that match the Batch Disposition Check types described above.
• Batch Disposition Check Item: A record such as batch record documents, deviations, and certificates that are tracked under checks to ensure they are complete prior to making a disposition decision. You can plan or automatically create document-type Batch Disposition Items for every batch being dispositioned under a given plan. You cannot plan Quality Event-type Batch Disposition Items but you can associate them with a Batch to ensure their closure prior to making a disposition decision.
• Batch Disposition Check Item Requirement: A record that relates a document or document template to a Batch Disposition Plan so that the document is created for every Batch Disposition created from the plan.

Batch Release Features

Vault Batch Release is built on the Vault platform and therefore has the features that are described in the Platform help topics. In addition, it includes capabilities specific to managing the batch disposition process:

• Batch Release Execution Page: This page is a unified interface that facilitates the release process by automatically aggregating batch-related information from quality, regulatory, and manufacturing systems to support a disposition decision.
• Batch Disposition Workflow: You can configure and initiate a workflow for Batch Disposition records to manage tasks and set lifecycle states based on the completion of those tasks and checks.
• Batch Release Roles: With this feature, you can manage who can be assigned to roles on Batch Disposition records and what application role Vault grants them when assigned. Vault also cascades disposition role assignments to their children Batch Disposition Checks.
• Automatic Check Completion: You can configure Vault to automatically complete Batch Disposition Checks upon item closure so that users don’t need to make a decision to move them forward to be ready.
• Batch Genealogy: You can configure Vault to generate a genealogy of a single batch, all its inputs, and related quality events.