Setting Up Batch Release

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.

You can configure a workflow to collect decisions from reviewers and solicit release decisions and their approval while managing the lifecycle states of each Batch Disposition record. Release decisions are typically made after their checks are compliant. Additionally, you can configure compliance logic for checks. This article outlines the configuration steps required to set up the Vault Batch Release feature for your organization’s business needs.

Setup Overview

Complete the following setup and configuration steps to set up the batch release capability in your Vault:

  1. Define Batch Disposition Plans.
  2. Define Batch Disposition Check Requirements.
  3. Define Batch Disposition Item Requirements.
  4. Approve Batch Disposition Plans for use.
  5. Configure entry and user actions for automation.
  6. Optional: Configure Batch Release roles.

Creating Batch Disposition Plans

You can define batch Batch Disposition Plans to provide a template for users to automatically create Batch Disposition records for a batch of a specified material with all associated Batch Disposition Checks and Batch Disposition Item Requirements. Plans will also define security, accountability, required approvals, and default due date for the Batch Disposition.

To create a Batch Disposition Plan:

  1. Navigate to Business Admin > Batch Disposition Plans or to a custom tab for Batch Disposition Plans.
  2. Click Create.
  3. From the dialog, select a Batch Disposition Plan Type from the drop-down and click Continue.
  4. Populate the Title, Due Date Offset Days, Disposition Title, and Owner fields.
  5. Optional: Select the Auto Generate Disposition checkbox to enable Vault to asynchronously generate a Batch Disposition record for a particular Batch when the Batch enters a specified lifecycle state.
  6. Populate any remaining required fields and click Save.

Upon creation, the Batch Disposition Plan is in the In Design state. From the related object sections, you can associate the plan with Materials and Check Requirements. You must review and approve Batch Disposition Plan records in order for them to become Effective for use.

Creating Batch Disposition Check Requirements

You can create multiple Batch Disposition Check Requirements for a Batch Disposition Plan as reusable requirements configured to check a requirement for a Batch Disposition.

There are three (3) types of Batch Disposition Check Requirements:

  • 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. Document 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 Disposition: Monitors the state of all Batch Dispositions for batches that were consumed to create this Batch.

To create a Batch Disposition Check Requirement:

  1. Navigate to Business Admin > Batch Disposition Check Requirements or to a custom tab for Batch Disposition Check Requirements.
  2. Click Create.
  3. From the dialog, select a Batch Disposition Check Requirement Type from the drop-down and click Continue.
  4. Populate the Title, Check Title, and Document Type fields.
  5. Optional: Select Yes for the Automatic field to enable 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.
  6. Populate any remaining required fields and click Save.

Upon creation, the Batch Disposition Check Requirement is in the In Design state. From the related object sections, you can associate the plan with Batch Disposition Item Requirements.

Creating Batch Disposition Item Requirements

You can create multiple Batch Disposition Item Requirements for a given Batch Disposition Check Requirement. Item requirements relate a document template to a plan so that the document is created for every disposition created from the plan.

To create a Batch Disposition Item Requirement:

  1. Navigate to Business Admin > Batch Disposition Check Requirements or to a custom tab for Batch Disposition Check Requirements.
  2. Select a record and navigate to the Item Requirements section.
  3. Click Create.
  4. Select a Document and click Save.

Reviewing & Approving Batch Disposition Plans

Business administrators or quality managers must design, revise, and approve Batch Disposition Plans with all specified required checks needed for a given material and its intended market or usage. Upon approval, you can create Batch Dispositions from a plan for every batch of the specified material type.

Vault manages the revision and approval of Batch Disposition Plans through user actions to progress the Batch Disposition Plan through its lifecycle. All Batch Disposition Check Requirements must be in the Effective state before the Batch Disposition Plan can transition to Effective.

Batch Release Automation Actions

Configuring an Entry Action to Create Batch Dispositions

Admins can configure Vault to automatically create a Batch Disposition record for a particular Batch when the Batch is activated. You must configure the Create Batch/Lot Disposition Record action as an entry action on the Active state of the Batch Lifecycle. You can also configure this as a user action.

Configuring an Entry Action to Complete Checks

Admins can configure Vault to automatically complete Batch Disposition Checks once all Batch Disposition Items are closed so that users don’t need to make a decision to move them forward to be ready. You must configure a conditional entry action on the Closed state of the Batch Disposition Item Lifecycle to change the state of the parent Batch Disposition Check to Complete if the check originates from a Batch Disposition Check Requirement with the Automatic field set to Yes.

Configuring an Entry Action to Close Checks

Admins can configure associated Batch Disposition Checks to close automatically upon the closure of the Batch Disposition record. You must configure an entry action on the Closed state of the Batch Disposition Lifecycle to change the state of all associated Batch Disposition Checks to Closed.

Configuring the Batch Release Workflow User Action

Admins should ensure that the Start Disposition Workflow user action is configured on the Batch Disposition Lifecycle for the Open state. This action starts the batch release workflow and sends a task to the assigned reviewer.

In order to set up Vault Batch Release, your permission set should have Read, Create, and Edit permissions to the following objects and their fields:

  • Batch Disposition Plan (disposition_plan__v)
  • Batch Disposition Check Requirement (batch_disposition_check_requirement__v)
  • Batch Disposition Item Requirement (batch_disposition_item_requirement__v)
  • Batch Disposition (batch_disposition__v)
  • Batch Disposition Checks (batch_disposition_check__v)
  • Batch Disposition Items (batch_disposition_item__v)