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 APQR process 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.
- Add the Generate Merged PDF Document user action to the document lifecycle: APQR Lifecycle.
- Configure object page layouts and custom actions for the associated objects.
- Add document, binder, and record creation actions to the appropriate lifecycle states.
- Create Management Review Templates as needed for your processes.
- Create APQR Programs as needed for your processes.
Document 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
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
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
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
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
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 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 |
| 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 |