Setting Up Batch Release

Batch Release is an application in the 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 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 and Action Triggers 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.

Parent and Child Batch Disposition Plans

Additionally, users can create a parent Batch Disposition Plan to manage plans for hundreds or thousands of Materials that share common Check Requirements and varying material-specific requirements. Common Check Requirements are managed in the parent plan, and material-specific requirements are managed in the child plan. Vault then combines the child and parent plans to create a Batch Disposition.

A child Batch Disposition Plan can have only one (1) parent plan. Users cannot enter a plan in the Parent Plan field if the selected plan already has a child or parent plan associated. Fields on the child plan take precedence over fields on the parent plan, but if a field is blank on a child plan, the corresponding field on the parent plan is used instead. A parent plan can point to the same Check Requirement as a child plan, but only the Check Requirement for the child plan is used, to ensure that duplicate checks are not created. A parent plan with materials associated creates Batch Dispositions based on its Check Requirements and configuration only.

Admins can configure the Batch object to determine which Date or DateTime field is used in a Batch Disposition Plan to calculate Batch Disposition Plan and Batch Disposition Check due dates. This allows Vault to use more than the standard Manufacturing Date field for calculating due dates. Both the Date and DateTime fields are available for use, but if neither field is selected, the standard Manufacturing Date field is used by default. Child Batch Disposition Plans inherit their values from their parent plans so both the Date and DateTime fields need to be blank before Vault will use the standard Manufacturing Date field. The Due Date field UI control must be added to the Batch Disposition Plan layout to enable this capability.

Manufacturing Site-Specific Plans

Users can associate a Batch Disposition Plan with a manufacturing site to ensure that only batches manufactured at that site are dispositioned by that plan. This can be helpful if your organization has manufacturing site-specific requirements to meet.

By utilizing the Disposition Plan - Organization join object, users can establish a relationship between the Batch Disposition Plan and their organization. When the Batch Disposition Plan has at least one (1) relationship with an organization, the plan becomes a manufacturing site-specific plan that can only be used by batches manufactured at that site.

Batch Disposition Plan Dependencies

Batch materials with multiple Batch Disposition Plans can have dependencies that block a disposition decision until other disposition decisions are made. For example, if configured by an Admin, your organization can block all market-ship decisions until the batch’s GMP Batch Disposition is closed and accepted.

The Related Disposition Plan object is used to create dependencies between Batch Disposition Plans. As Batch Dispositions are created, Vault creates Batch Disposition Item records based on these dependencies, which are closed when blocking Batch Dispositions are closed. A dependent Batch Disposition record will not be created if a blocking Batch Disposition record does not exist.

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. Click the binoculars icon, select a Type, a Subtype, and a Classification for monitoring documents, and then click OK.
  6. 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.
  7. 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.

Sharing Batch Disposition Documents

To enable Batch Release users to share Batch Disposition documents with external VeevaID users, Admins can configure the Share Disposition entry or user action. Vault sends the selected persons an email with a link to the Batch Disposition Share App Page, where they can view and download selected documents as PDF files.

You can add and select persons in the Persons section on the Batch Disposition Plan with Type set to Share Disposition or, when configured, in the Share Disposition dialog after performing the Share Disposition user action. Persons must have a user account to be added to the Batch Disposition Plan.

You can select which documents to share for a given Batch Disposition using the Share field on the Batch Disposition Plan and the Share field in the Check Requirements sections. The Batch Disposition Share App Page displays a maximum of 100 documents.

When you share a Disposition, Vault gives the users the Consumer role for documents and Viewer role for the Disposition.

Batch Disposition Item Status

The Item Creation Status picklist on the Batch Disposition object is set during the creation of a Batch Disposition. When the Disposition creation job begins, the Item Creation Status is set to In Progress. When complete, Vault updates the field to Done. In the event that the job fails, Vault sets the Item Creation Status to Failed.

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 Check Requirements 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 this in the 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 an Action Trigger to Close Items

Admins can configure Action Triggers to automatically close Batch Disposition Items based on related record criteria.

We recommend configuring the following Action Triggers:

  • To change the state of the Batch Disposition Item to Closed if the related Deviation record is Closed and if the Impact Batch? field is blank:
    • Deviation object
    • After Save
    • If Not(IsBlank(deviation__v)) && deviation__vr.state__v="closed_state__v" && CountA(GetRecords($deviation_batch__v, "quality_batch__v = and deviation__v = and batch_impact__v = true")) = 0 && CountA(GetRecords($deviation_batch__v, "quality_batch__v = and deviation__v = and batch_impact__v = null")) = 0;
    • Then ChangeState(ThisRecord(), $closed_state__v);
  • To change the state of the Batch Disposition Item to Closed if the related Change Control record is Closed:
    • Change Control object
    • After Save
    • If Not(IsBlank(change_control__v)) && change_control__vr.state__v="closed_state__v";
    • Then ChangeState(ThisRecord(), $closed_state__v);
  • To change the state of the Batch Disposition Item to Closed if the related Quality Event (Deviation type) record is Closed and the Impact Batch? field is blank:
    • Deviation type of the Quality Event object
    • After Save
    • If Not(IsBlank(quality_event__v)) && quality_event__vr.state__v="closed_state__c" && quality_event__vr.object_type__vr.api_name__v="deviation__qdm" && CountA(GetRecords($quality_event_batches__v, "quality_batch__v = and quality_event__v = and batch_impact__v = true")) = 0 && CountA(GetRecords($quality_event_batches__v, "quality_batch__v = and quality_event__v = and batch_impact__v = null")) = 0;
    • Then ChangeState(ThisRecord(), $closed_state__v);
  • To change the state of the Batch Disposition Item to Closed if the related Quality Event record is Closed:
    • Quality Event object
    • After Save
    • If Not(IsBlank(quality_event__v)) && quality_event__vr.state__v="closed_state__c";
    • Then ChangeState(ThisRecord(), $closed_state__v);
  • To change the state of the Batch Disposition Item to Closed if the related Batch Disposition record is Closed:
    • Batch Disposition object
    • After Save
    • If Not(IsBlank(input_batch_disposition__v)) && batch_disposition__vr.state__v="closed_state__v";
    • Then ChangeState(ThisRecord(), $closed_state__v);

Configuring an Entry Action to Share Dispositions

Admins can configure Vault to automatically share selected Batch Disposition documents with users, including external users with VeevaID. You must configure the Share Disposition action as an entry action on the Closed state of the Batch Disposition Lifecycle. You can also configure this action as a user action in any state that your process requires.

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.

Configuring the Disposition Plan - Organization Object

Admins can configure the Disposition Plan - Organization join object to establish relationships between a Batch Disposition Plan and an organization. When a Batch Disposition Plan has at least one (1) relationship with an organization, the plan becomes a manufacturing site-specific plan that can only be used by batches manufactured at that site. If no relationship is established with a manufacturer’s site, the plan can be used by batches made anywhere. To utilize this join object, add the section for the Disposition Plan - Organization join object to the Batch Disposition Plan object layout.

Configuring Item Requirements

Admins can configure an Item Requirement on a Check Requirement which will create documents with the Batch field populated when a Batch Disposition is created.

Admins can specify whether to copy the document referenced in the Item Requirement or create an item reference for an existing document without copying it. This supports material-specific and manufacturing-specific documents like BSE/TSE certifications and other certifications that cover all batches produced during a specific period at a specific manufacturing site or for a specific material, to ensure that the batch was manufactured when the certifications were Effective. To apply this setting, select No from the Batch Disposition Item Requirement Copy Document picklist field.

Configuring Due Date Handling

Admins can configure whether due dates are displayed on the Batch Release Execution page in a date or a date and time format. If an Admin enables the Use Datetime field for Due Dates option under Admin > Settings > Application Settings, Vault displays the Due Date field on a Batch Disposition in the date and time format. If this option is not enabled, Vault displays the date format by default. To support this functionality, Admins need to add the Due Date (due_date_only__v) field to the Batch Disposition (batch_disposition__v) page layout.

Batch Release Manual Actions

Configuring Disposition Item Behavior

Admins can configure Vault to allow users to make decisions and justifications for Batch Disposition Items and close them from the Batch Release Execution page.

Begin by adding the Item Behavior (batch_disposition_check__v.item_behavior__v) picklist to the Batch Disposition Check Requirement and Batch Disposition Check object page layouts. When you set the picklist to Automatic & Manual, users can add decisions and justifications to Batch Disposition Items and close them from the Batch Release Execution page. When the picklist is set to Automatic Only or left blank, Vault closes items through automated action triggers or entry actions on the related record.

Also configure the Compliant user action on the Batch Disposition Item lifecycle in the Open state to set the lifecycle state to Closed and Decision to Compliant. Then configure the Not Compliant user action on the Batch Disposition Item lifecycle in the Open state to set the decision to Not Compliant and the lifecycle state to Closed.

In order to set up 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)