# Batch Release Overview 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](/en/lr/713885/) 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 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**](/en/lr/713885/): 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**](/en/lr/781133/): 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**](/en/lr/771993/): You can configure Vault to generate a genealogy of a single batch, all its inputs, and related quality events.