# Configuring Annual Product Quality Reviews (QMS)

QMS supports management of the Annual Product Quality Review (APQR) process, which is an annual evaluation of the quality standard of a drug product to determine the need for adjustments in drug product specifications, manufacturing, and control procedures. It is a collaborative effort to generate a final APQR report. The report consists of a compilation of data from multiple data sources, the summarized results, and the recommendations from distinct SMEs.

This article contains basic configuration information to outline an <a href="/en/gr/78659/">APQR process</a> in your Vault.

## Setup Preparation

Before configuring components for the APQR process, it can be helpful to create a plan which lists the needs for your organization's process for your own reference while configuring APQR functionality, including:

*   Documents and data included in the final report
*   Order of documents in the final report
*   Document types for included documents
*   Lifecycle states in which data and documents will be created and finalized

## Configuration Overview

Configure the following components to use APQR functionality:

*   [Configure document types and fields.][1]
*   [Add the _Generate Merged PDF Document_ user action to the document lifecycle: _APQR Lifecycle_.][5]
*   [Configure object page layouts and custom actions for the associated objects.][2]
*   [Add document, binder, and record creation actions to the appropriate lifecycle states.][4]
*   <a href="/en/gr/78659/#creating-mrts">Create _Management Review Templates_ as needed for your processes.</a>
*   [Create _APQR Programs_ as needed for your processes.][6]

## Document Field Setup {#doc-field-setup}

Before configuring document generation actions, you must add an object reference field referencing the _APQR_ object to each document type to be included in the final report. When a user performs the document generation action, this field is populated with a link to the originating _APQR_ record.

Conflicting field requiredness between the _APQR_ object and document types can cause the binder and final report generation actions to fail due to incomplete data. Ensure that you reconcile document field requiredness on your target document types to fields on the _APQR_ object in order for the _Generate APQR Binder_ action to complete successfully.

## Document Lifecycle Setup {#doc-lifecycle-setup}

Add the _Generated Merged PDF Document_ action to an appropriate state in the _APQR Lifecycle_ document lifecycle. This action generates the APQR final report, so it should be added to a state after all documents and data for the APQR have been finalized.

Add the _Generate Document Support_ action to the appropriate state in the _APQR Program_ document lifecycle to activate the _APQR Program_ document type. This action generates a report of the documents available in the _APQR Program_.

## Setting Up the APQR Object {#apqr-object}

Make the following changes to the _APQR_ object configuration to support the APQR process:

* Add the _Generate APQR Binder_ custom action to the object configuration.
* Add an _APQR Item_-related object section on the _APQR_ object page layout.
* Add the _APQR: Generate Merged PDF_ action to generate the _Final Report_ from the record.
* Ensure that the _Final Report_ field is active and displayed in the necessary layout to generate the _Final Report_ from the record.
* Ensure that the _APQR Program_, _Proposed APQR_, and _Organization_ fields are active and displayed on the _APQR_ object page layout to track generated _APQR Programs_, related _Proposed APQRs_, and their associated organizations.
* Add the _Related APQR Program_ and _Related Proposed APQR_ sections on the APQR object page layout, and configure the change state for the related object records to track the execution of the _APQR Program_ and _Proposed APQRs_.

## Setting Up the Management Review Template Object for APQRs {#mrt}

Make the following changes to the _Management Review Template_ object to support the APQR process:

*   Add the _Create Record From Template_ custom action to the object configuration.
*   Add a _Management Review Template Item_ related object section on the _Management Review Template_ object page layout for the _APQR_ object type.

## APQR Object Lifecycle Setup {#object-lifecycle-setup}

The APQR process relies on several actions configured on the appropriate object lifecycle states.

### APQR Lifecycle

Add the _Generate APQR Binder_ user action or the _APQR: Generate Merged PDF_ user action to a state in the _APQR_ object lifecycle after all _APQR Items_ have been created.

### APQR Item Lifecycle

Add Quality document generation actions to the _APQR Item_ lifecycle in the appropriate states. Depending on the expected content of the resulting documents and availability of the sourced data, you can add them as entry actions on the _Initial_ state, user actions in the _In Progress_ state or other combinations as necessary for your process.

### Management Review Template Lifecycle

Add the _Create Record From Template_ user action to the _Management Review Template Lifecycle_ in an appropriate state so that users can create _APQRs_ from established templates.

## Setting Up the APQR Program Objects {#apqr-program-objects}

Activate the _APQR Program Template_, _APQR Program_, _Proposed APQR_ objects. These objects ensure that users can automatically generate _APQR_ records from an _APQR Program_ and its related _Proposed APQRs_. Ensure that the _Generate APQR Program from Template_ user action is available on the _APQR Program Template_ object.

Activate the _Organization_ and _Product_ join objects for the _APQR Program Template_, _APQR Program_, _Proposed APQR_, and _APQR_ objects. These join objects will associate the correct organizations and products with the _APQR Programs_ and _Proposed APQRs_.

## APQR Program Object Lifecycle Setup

_APQR Programs_ rely on several actions configured on the appropriate object lifecycle states.

### APQR Program Template Lifecycle

Add the _Generate APQR Program from Template_ user action to the _APQR Program Template_ lifecycle. This action generates the _APQR Program_ and related _Proposed APQRs_.

### Proposed APQR Lifecycle

Add the _Generate Program from Record_ system action to the _Approved_ state type on the _Proposed APQR_ lifecycle. When executed, this action runs a job that reviews the start date for the _Proposed APQR_, ensures that the _Proposed APQR_ is active and _Approved_, and creates the _APQR_ record when the start date occurs.

## Limitations/Best Practices

The following limitations apply to QMS's APQR functionality:

*   You can only configure the _Generate Merged PDF_ action on the _APQR Lifecycle_ document lifecycle, and can only run it from the _APQR Binder_.
*   The document output of the _Generate Merged PDF_ action can only be of the _APQR > Final Report_ document subtype.

## Related Permissions

Your security profile requires the following permissions to work with APQRs:

|Type|Permission Label| Controls
|--- |--- |--- |
|Document Types created by <a href="/en/gr/72016/">Quality Document Generation Actions</a>|Create Document|Ability to create documents for _APQR Items_|
|Document Type (APQR Binder)|Create Binder|Ability to create an _APQR Binder_ with the _Generate APQR Binder_ action|
|Document Type (Final Report)|Create Document|Ability to create a _Final Report_ document using the _Generate Merged PDF_ action|
|Document Type (APQR Program)|Create Document|Ability to create documents for _APQR Programs_ with the _Generate Document Support_ action|
|Security Profile|Object: Management Review Template: Create, Read, Edit, Delete|Ability to create, view, edit, and delete _Management Review Templates_ for use as the basis of _APQR_ record creation|
|Security Profile|Object: Management Review Template Item: Create, Read, Edit, Delete|Ability to create, view, edit, and delete _Management Review Template Items_ for use as the basis of _APQR Item_ record creation|
|Security Profile|Object: APQR: Create, Read, Edit, Delete|Ability to view, create, edit, and delete _APQR_ records during the APQR process|
|Security Profile|Object: APQR: Generate Merged PDF: View, Execute|Ability to view and execute the action|
|Security Profile|Object: APQR Item: Create, Read, Edit, Delete|Ability to view, create, edit, and delete _APQR Item_ records during the APQR process|
|Security Profile|Object: APQR Program: Create, Read, Edit, Delete|Ability to view, create, edit, and delete _APQR Program_ records during the APQR process|
|Security Profile|Object: Proposed APQR: Create, Read, Edit, Delete|Ability to view, create, edit, and delete _Proposed APQR_ records during the APQR process|
|Security Profile|Object: APQR Program Template: Create, Read, Edit, Delete|Ability to view, create, edit, and delete _APQR Program Template_ records during the APQR process|

  [1]: #doc-field-setup
  [2]: #apqr-object
  [3]: #mrt
  [4]: #object-lifecycle-setup
  [5]: #doc-lifecycle-setup
  [6]: #apqr-program-objects