# Using 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.

While the APQR process, as well as object and action labels, may differ between organizations, the examples in this article assume a typical configuration. The procedure in your Vault may differ, depending on the [configuration](/en/lr/78661/) determined by your Admin.

## How APQR Management Works

APQR management in QMS centers around the _APQR_ object, one or more _Management Review Templates_, and actions available on the associated object records. When you create an _APQR_ object record from a template, Vault transfers data to that record based on the configuration of the chosen template.

The APQR process typically includes the gathering of data in documents, stored as _APQR Items_ on the _APQR_ record. When you create an _APQR_ record from a _Management Review Template_, Vault also creates any _APQR Items_ which were included on the template.

As part of data collection, you can use actions available on the _APQR_ record to create related documents and binders. Once all documents have been collected, you can use an action to create the final APQR report as a PDF.

## Example APQR Process Overview

When performed in QMS, a typical APQR process includes some or all of the following components:

  *   [Create a _Management Review Template_][1]
  *   [Create an _APQR_ object record][2]
  *   [Create an _APQR Program_][6]
  *   [Generate documents][3]
  *   [Generate an APQR binder][4]
  *   [Generate an APQR final report][5]

## Creating Management Review Templates for APQRs {#creating-mrts}

To create a _Management Review Template_ for use in a typical APQR process:

  1.  Navigate to **Business Admin > Management Review Templates** or to a custom object tab.
  2.  Click **Create**.
  3.  Fill in a **Name** and any other fields which all APQRs in your process will require. When you create an _APQR_ record from this template, Vault transfers field data such as _Country_, _Owning Facility_, and _Product_ to the resulting record, along with any other fields configured by your Admin to transfer data.
  4.  Click **Save**.
  5.  In the _Management Review Template Item_ section, click **Create** to make a related _Management Review Template Item_ object for each expected item in your APQR process.
  6.  If applicable, select a **Document**.
  7.  Optional: Enter a **Display Order**. Vault orders any APQR Items in this order during APQR binder generation. Vault displays any documents which lack a _Display Order_ value in alphabetical order, after any documents with a defined display order.
  8.  Click **Save**.

## Creating APQRs {#creating-apqrs}

While you can create an APQR record manually, use the following steps to create an APQR from a template:

  1.  Navigate to a _Management Review Template_ record of the _APQR_ object type, either in **Business Admin** or in a custom object tab.
  2.  Perform the **Create Record From Template** action on the record.

When you perform this action, Vault creates the _APQR_ record, gives it a system-managed record name, and transfers data and _APQR Item_ related records from the template to the new record.

## Creating APQR Programs {#creating-apqr-programs}

You also can create an _APQR Program_ that automatically generates _APQR_ records for a specified time period. This allows you to manage your APQR schedule to meet the ongoing demands of your organization. The _APQR Program_ can be generated using an approved _APQR Program Template_.

To create an _APQR Program Template_:

1. Navigate to **Business Admin > APQR Program Templates** or to a custom object tab.
2. Click **Create**.
3. Fill in a **Name** and any other fields which all APQRs in your process will require. When you create an _APQR Program_ record from this template, Vault transfers field data such as _Country_, _Owning Facility_, and _Product_ to the resulting record.
4. Under the _Proposed APQR_ section, click **Create**.
5. Select a **Proposed APQR Type** and click **Continue**.
6. Select the _APQR Program Template_ to automatically populate the data for the _Proposed APQR_ record details, and click **Save**.
7. Send the _APQR Program Template_ for approval.

Once the template is approved, you can execute the _Generate APQR Program from Template_ action to start the _APQR Program_. Vault then creates the _APQR Program_ and associated _Proposed APQR_ records for review.

When the _Proposed APQRs_ reach the _Approved_ lifecycle state type by the scheduled start date, a system action runs in the background to automatically create the _APQR_ records.

## Generating APQR Documents {#generating-apqr-docs}

APQR processes typically include gathering data into documents for inclusion in the final report. These may be existing Vault documents, new formatted outputs, documents created from document templates, or documents created from reports. QMS stores these documents as _APQR Items_, related to the parent _APQR_ record. Some documents may be automatically generated when you create the _APQR_ record from the template. Others, such as documents created from reports, can be created by performing the appropriate action on the _APQR Item_ record:

  1.  Navigate to the _APQR Item_ section of the _APQR_ object record details page.
  2.  Perform the document generation action on the _APQR Item_ record. For example, perform the **Generate Document from Report** action to attach a PDF version of the report to the _APQR Item_ record.

When you perform this action, Vault populates a document reference field on the _APQR Item_ record with a link to the generated document. The availability and labels of document generation actions depend on the configuration of your Vault, as determined by an Admin.

## Generating APQR Binders {#generating-apqr-binders}

After all documents to complete the APQR have been collected or had placeholders created for them, you can create a binder to contain them all in your Vault library. Before performing this step of the APQR process, ensure there is an _APQR Item_ for each required document.

To generate the APQR binder, perform the **Generate APQR Binder** action on the _APQR_ object record. When you perform this action on an _APQR_ record, Vault creates a document binder containing all documents referenced by the record's related _APQR Items_ and assigns it the same name as the _APQR_ record from which it originated. Vault orders _APQR Item_ documents in the binder according to their _Display Order_ field value.

## Generating APQR Final Reports {#generating-apqr-final-reports}

Once the documentation and data in the _APQR_ have been finalized, a typical APQR process includes the generation of a final report. To generate a single PDF document containing all documents referenced by the _APQR Items_ in the _APQR_ record, perform the **Generate Merged PDF** action on the APQR binder or directly from the _APQR_ record. Through the **Generate Merged PDF** action on the _APQR_ record, you can merge up to 100 related records containing the documents referenced and decide whether to include nonsteady state documents in the _Final Report_.

When you perform this action, Vault creates the combined PDF document and stores it as the _APQR > Final Report_ document type, and creates a link to the document from the associated _APQR_ record. This link updates each time a user performs the _Generate Merged PDF_ action. If the action is unsuccessful, Vault provides reasons for the failure, including on which specific document the error occurred.

## Related Permissions

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

|Type|Permission Label|Controls|
|--- |--- |--- |
|Document Types created by [Quality Document Generation Actions](/en/lr/72016/)|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 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]: #creating-mrts
  [2]: #creating-apqrs
  [3]: #generating-apqr-docs
  [4]: #generating-apqr-binders
  [5]: #generating-apqr-final-reports
  [6]: #creating-apqr-programs