Veeva 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.
Note: You must have Veeva QMS in order to use Veeva Batch Release. Contact your Veeva representative for more information.
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 Dispositions that have been closed or cancelled for over 24 months are archived. All records associated with the Batch Disposition, Batch Disposition Check, Batch Disposition Item, and Batch Disposition - Country records are deleted, and a Disposition PDF is attached to the Batch record for archival.
Batch Release Data Model
The Veeva 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.
- 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 eight types of Batch Disposition Check Requirements that match the Batch Disposition Check types described below.
- 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.
About Batch Disposition Check Types
Veeva Batch Release includes eight types of Batch Disposition Checks.
- Deviation & Lab Investigations
- The Deviation and Lab Investigation checks monitor all Deviations or Lab Investigations in all states related directly to the individual batch or, when the Include Genealogy field value is Full, all batches in the genealogy. The By Exception option is useful for these check types if you only want to surface records that were not reviewed in a prior Disposition.
- Change Controls
- The Change Control check monitors implemented Change Controls for an individual batch’s Material or, when the Include Genealogy field is Full, all Materials in the batch’s genealogy for implementation. Define Change Controls by configuring the monitored lifecycle states in the Change Control check. When the batch genealogy is unavailable, Change Controls can still monitor the Material genealogy by relating Materials to each other and setting the Include Genealogy field to Full - Material. You can also use the Change Control check type to monitor changes related to the batch or batches in the genealogy, similar to the Deviation and Lab Investigation check types.
- Documents
- The Document check monitors certificates, batch records, and other documents that need to be reviewed and completed. Documents may be added to Document checks in the following ways:
- Automatically created per the Disposition Plan Item Requirement. This option is ideal for most batch-specific documents.
- Automatically referenced per the Disposition Plan Item Requirement. This option is ideal for non-batch specific certificates, such as a TSE/BSE certification, that cover all batches produced during a specific period at a specific manufacturing site.
- Added directly from a Disposition. This option is ideal when it is not clear exactly which documents will be reviewed.
- Automatically created based on relationship to the batch and document type. This is ideal for documents created by another application or process.
- Dispositions
- The Disposition check monitors the state of all Batch Dispositions for batches that were consumed to create this batch and dispositions for the target batch which the disposition depends on. Items are created for both open dispositions and closed dispositions that are not accepted. For example, use this to check the disposition decision for a GMP disposition before making a Market Ship decision. Batch Disposition Checks are market-specific.
- Regulatory
- The Regulatory check monitors market approvals for Change Controls affecting materials used to make a finished product batch. Market approvals are managed in the Regulatory Activity Item associated with finished product materials defined in the Regulatory Change Item. This check type ensures compliance with various health authorities. Similar to the Change Control check, the lifecycle states to monitor are defined in the check requirement. If the batch genealogy is not available, you can use the bill of materials by setting Include Genealogy to Full - Material.
- Qualifications
- The Qualification check monitors QMS Qualifications or Supplier Qualification Management records when dispositioning batches to ensure materials used were manufactured by approved suppliers and/or manufacturing sites. The lifecycle states of the Qualification records to monitor are defined in the check requirement. You can also select No Record Found to create items when there are no Qualification records.
- Bill of Materials
- The Bill of Materials check compares the batch genealogy in related batch records to the Bill of Materials in related material records to ensure the batch genealogy data is accurate and the correct materials were used during batch creation. This check type allows users to verify that products are built to specification, which is especially valuable for pharmaceutical companies.
Batch Release Features
Veeva Batch Release is built on the Veeva 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.