Vault 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 determined by your Admin.
How APQR Management Works
APQR management in Vault 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 Vault QMS, a typical APQR process includes some or all of the following components:
- Create a Management Review Template
- Create an APQR object record
- Generate documents
- Generate an APQR binder
- Generate an APQR final report
Creating Management Review Templates for APQRs
To create a Management Review Template for use in a typical APQR process:
- Navigate to Admin > Business Admin > Management Review Templates or to a custom object tab.
- Click Create.
- 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.
- Click Save.
- 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.
- If applicable, select a Document.
- 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.
- Click Save.
While you can create an APQR record manually, use the following steps to create an APQR from a template:
- Navigate to a Management Review Template record of the APQR object type, either in Admin > Business Admin or in a custom object tab.
- 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.
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 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:
- Navigate to the APQR Item section of the APQR object record details page.
- 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
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
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.
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.
Your security profile requires the following permissions to work with APQRs:
|Document Types created by Quality Document Generation Actions||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|
|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|