# Performing APQR (QMS)

[QualityOne Vaults](/en/lr/78610/) support management of the APQR (Annual Product Quality Review) process, which is an annual evaluation of the quality standard of a product to determine the need for adjustments in product specifications, manufacturing, and control procedures. The final APQR report generated as the output of this process compiles data from multiple sources, along with the summarized results of the review and the recommendations from distinct subject matter experts.

APQR is part of the Periodic Reviews feature that provides shared functionality to let users perform different types of periodic reviews in Vault. See [Periodic Reviews Overview](/en/lr/679530/) for more details.

Depending on your [Admin's configuration](/en/lr/628772/), object, field, and section labels may appear differently than the labels mentioned in this article.

## How the APQR Process Works {#apqr-process}

The APQR process begins when you [create an _APQR_][1] from a _Periodic Review Template_. Vault transfers data to that record based on the configuration of the chosen template and creates _APQR Items_ from the template.

The APQR process typically includes gathering and analyzing data (for example, batch information, supplier qualifications, stability studies, and change controls) in documents stored as _APQR Items_ on the _APQR_ record. You can use the object actions available on the _APQR_ record to facilitate data collection and create related documents and binders.

Once you have collected all necessary documents, you can use an action to create the final APQR report as a PDF. The _Final Report_ PDF contains all supporting documents in the _APQR_, the summarized results of the review, and recommendations from subject matter experts.

## APQR Process Overview {#apqr-overview}

The general process of working with APQR involves the following steps:

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

## Creating Periodic Review Templates for APQRs {#pr-templates}

To create a _Periodic Review Template_ for use in a typical APQR process:
1. Navigate to **Business Admin > Periodic Review Templates** or to a custom object tab.
2. Click **Create**.
3. Select **APQR** as the _Periodic Review Template Type_.
4. Enter a **Name**. 
5. Select a **Product**. When you create an _APQR_ record from this template, Vault transfers field data from _Product_ to the resulting record and any other fields configured by your Admin to transfer data.
6. Optional: Select an **Organization** or **Facility**.
7. Click **Save**.
8. In the _Periodic Review Template Item_ section, click **Create** to make a related _Periodic Review Template Item_ object for each expected item in your APQR process.
9. Optional: Select a **Document**.
10. Optional: Enter a **Display Order**. Vault orders any _APQR Items_ in the order you specify here during APQR binder generation. Vault displays any documents that lack a _Display Order_ value in alphabetical order after any documents with a defined display order.
11. Click **Save**.

## Creating APQRs {#creating-apqrs}

While you can create an _APQR_ record manually, we recommend you use the following steps to create an _APQR_ from a _Periodic Review Template_:
1. Navigate to **Business Admin > Periodic Review Template**.
2. Open a _Periodic Review Template_ record of the _APQR_ object type.
3. Select the **Create Record From Template** action from the **All Actions** menu.

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

## Generating APQR Documents {#generating-documents}

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. Vault stores these documents as _APQR Items_, related to the parent _APQR_ record. Vault may automatically generate some documents 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 appropriate _APQR_ object record details page.
2. In the _APQR Item_ section,  [select the required document generation action](/en/lr/553724/#how-to) on the _APQR Item_ record. For example, run the **Generate Document from Report** action to attach a PDF version of the report to the _APQR Item_ record.

When you generate a document, Vault populates the document reference field on the _APQR Item_ record with a link to the generated document.

## Generating APQR Binders {#generating-binders}

After you have collected or created placeholders for all documents to complete the APQR process, you can create a binder to contain your related artifacts 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, run 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 _APQR's_ related _APQR Items_ and assigns the same record label as the source _APQR_ record. Vault orders _APQR Item_ documents in the binder according to their _Display Order_ field value.

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

After you have generated the APQR binder, a typical APQR process includes generating a final report. To generate a single PDF document containing all documents referenced by the _APQR Items_ in the _APQR_ record, run the **Generate Merged PDF** action on the APQR binder.

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

## Limitations {#limitations}

The following limitations apply to APQR functionality:

* No more than 50 _Periodic Review Template Items_ can be added per _Periodic Review Template_ record.
* Documents generated from the _Generate Merged PDF Document_ user action cannot exceed 20,000 pages or 4GB in size.

[1]: #pr-templates
[2]: #creating-apqrs
[3]: #generating-documents
[4]: #generating-binders
[5]: #generating-reports