Performing APQR (QMS)

QualityOne Vaults 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 offering that provides shared functionality to enable users to perform different types of periodic reviews in Vault. See Periodic Reviews Overview for more details.

Depending on your Admin’s configuration, object, field, and section labels may appear differently than the labels mentioned in this article.

How the APQR Process Works

The APQR process begins when you create an APQR 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

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

Creating Periodic Review Templates for APQRs

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

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

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 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

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

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

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.