Configuring Periodic Review (QualityDocs) | Vault Help (2024)

The Vault QualityDocs periodic review feature set allows you to configure auto-starting periodic review workflows and follow-up tasks, and provides clear visibility on triggering Document Change Control records. This feature includes the Document Periodic Review job type, which identifies documents due for periodic review and creates a Periodic Review object record for each document. You can then configure a periodic review document workflow to automatically start when the Periodic Review record is created and issue follow-up tasks to ensure that the proper steps are taken based on the periodic review verdict.

About the Periodic Review Object & Lifecycle

Once created by the automated periodic review job, Periodic Review object records function as the envelope for periodic review workflows, each with its own document. The corresponding standard Periodic Review Lifecycle has a preset Initiated state which allows for workflow start entry actions and user actions related to the periodic review.

When the Document Periodic Review job type runs, it creates a Periodic Review record in the Created state before immediately changing the state to Initiated, which triggers any configured entry actions in that state, including the Start Periodic Review Workflow action. The job also links the applicable document to its associated Periodic Review record with reference in the Current Periodic Review object reference field on the document.

About Periodic Review Workflows

When Vault auto-starts periodic review workflows, there is no opportunity for user inputs such as participant selection, workflow due dates, or ad hoc instructions. Accordingly, the periodic review workflows you choose to automatically start with this feature set can’t require such input. Ensure that you have configured your document workflow with the appropriate options, that any role expected to participate in the workflow is assigned beforehand, and the document workflow utilizes the Use Roles as Participants option.

Configuration Overview

Configure the following Vault components to fully enable periodic review functionality:

  • Configure a job with the Document Periodic Review job type.
  • Add the Current Periodic Review and Current Periodic Review Workflow document fields to the appropriate document types. If these fields are not added, the Document Periodic Review job will fail with errors.
  • Configure the Start Periodic Review Workflow actions.
  • Add a Start Periodic Review Workflow entry action to the Periodic Review object lifecycle on the Initiated state.
  • Configure periodic review document workflows with the Update Periodic Review Lifecycle State system action.
  • Add the Associated Periodic Reviews section to the Document Change Control object page layout.
  • Add an entry action in the Document Change Control object lifecycle if you want to automatically set the periodic review workflow to Complete once the DCC is Closed.
  • Add a user or entry action in the Document Change Control object lifecycle if you want to automatically link applicable Periodic Review records.

Configuring the Periodic Review Job

Automated Vault jobs with the Document Periodic Review job type identify documents due for periodic review by checking if a triggering date has elapsed. The job type has options specifically related to periodic reviews in addition to the standard job definition options. We recommend configuring this job type to run after any auto-effectivity jobs or auto-obsolescence jobs, to ensure that documents are in their appropriate lifecycle states before the system checks for periodic review readiness.

To configure a job with the Document Periodic Review job type

  1. Navigate to Admin > Operations > Job Definitions.
  2. Click Create.
  3. Fill in the standard job definition fields. Note that the Job Owner user or group receives notifications if the job fails for any reason.
  4. In the Job Type drop-down, select Document Periodic Review.
  5. In the Action Configuration section, choose the relevant document lifecycle from the Lifecycle drop-down. Documents in this lifecycle are checked by the job to determine whether a Periodic Review record should be created.
  6. Optional: Define further limiting criteria for the readiness check with the Additional Conditions drop-down. You can add multiple conditions by clicking the (+) icon.
  7. In the Trigger Date drop-down, select the document date field you want Vault to check against to determine periodic review readiness. You can include the date of the job run in this determination by choosing is before or is on or before.

When the job runs, Vault creates a Periodic Review object record for any documents which fit the lifecycle, conditions, and date trigger you have defined.

Configuring the Start Periodic Review Workflow Action

In order for Vault to automatically start a review workflow for the document in a Periodic Review record, you must configure the Start Periodic Review Workflow entry action on the Initiated state in the Periodic Review Lifecycle.

This action is also available as a user action in the same state. This is useful if the review workflow was unable to automatically start via the entry action for any reason.

Both the entry action and user action have two required inputs:

  • Document Lifecycle: Choose the document lifecycle which has a defined periodic review workflow.
  • Multi-Document Workflow: Choose the periodic review workflow that you want to start upon triggering this entry action. Only the workflows valid for the chosen lifecycle appear in the drop-down. Note that legacy workflows are not valid for this action.

The action also has two optional settings:

  • Do not start periodic review if a later document version exists: Select this setting if your business processes do not require a periodic review for a document which already has a newer version.
  • Do not start periodic review if the steady state document is in a DCC approved for obsolescence: Select this setting to prevent Vault from starting the review workflow in cases where the document is approved to be made obsolete soon.

Note that if you have more than one document lifecycle with a periodic review process, such as both a Draft to Effective and a Draft to Approved lifecycle, you may need to configure this entry action more than once. To do this, select the Perform with conditions option to define a specific entry action for each of your applicable document lifecycles using the document lifecycle field on the periodic review object.

Configuring the Periodic Review Lifecycle

To allow users to complete their periodic review business process with the fewest manual steps, it is recommended to configure a Start Workflow entry action which assigns a task to create a Document Change Control record after the Periodic Review record has changed to a Make Obsolete or Needs Revision state.

Configuring Periodic Review Workflows

To keep the Periodic Review object record state in sync with the periodic review verdict, add the Update Periodic Review Lifecycle State system action step in your periodic review workflow. For example, if the periodic review verdict is Needs Revision, use the system action to move the corresponding periodic review object record to the Needs Revision destination state. This action specifically affects only the Periodic Review record that corresponds to the document in the workflow.

When you select this system action, you must choose a Destination State for the record. You can define multiple system action steps to account for multiple verdicts in your workflow.

Configuring the Document Change Control Object Page Layout

You can add the Associated Periodic Reviews section to the Document Change Control object page layout to make it easy to access and track the status of relevant periodic reviews. Users can add individual Periodic Review records to this section, associating them with the Document Change Control. Adding an Associated Periodic Review record to a Document Change Control will populate the Governing Change Control field on the periodic review object. You cannot modify the Governing Change Control directly from the Periodic Review record, this can be done from the Associated Periodic Review section on the Document Change Control.

Configuring the Document Change Control Object Lifecycle

To ensure that Periodic Review records change to the Complete state at the appropriate time, configure a Change related object lifecycle state entry action in the Document Change Control object lifecycle, in the Closed state:

  1. In the Entry Actions section of the Closed state of the Document Change Control object lifecycle, click Edit.
  2. Click Create Entry Action.
  3. Select Change related object lifecycle state from the drop-down.
  4. In the Related Object drop-down, select Periodic Reviews.
  5. In the Change State To drop-down, select Complete.
  6. Select the Conditions on Related Records checkbox.
  7. In the Conditions drop-down, select Include related records in the following lifecycle states.
  8. In the Related Record’s State box, select the Needs Revision and Make Obsolete states.
  9. Click Save.

Link Available Periodic Reviews Action

Optionally, you can configure the Document Change Control object lifecycle to include the Link Available Periodic Reviews entry action or user action on an appropriate state.

This action, when executed, adds any Periodic Review records which target the document or documents to be made effective to the Document Change Control as related records.

Configuring Periodic Review (QualityDocs) | Vault Help (2024)

FAQs

Configuring Periodic Review (QualityDocs) | Vault Help? ›

Periodic review processes tell the system who needs to review a document every two years or every year to see if it is still current, correct, and up-to-date. You can have as many users as you like to perform the periodic review.

What is the process of periodic review? ›

Periodic review processes tell the system who needs to review a document every two years or every year to see if it is still current, correct, and up-to-date. You can have as many users as you like to perform the periodic review.

What is Veeva QualityDocs? ›

Vault QualityDocs is an application to manage documentation associated with a quality system, providing seamless collaboration, reducing compliance risk, and improving quality processes. It accelerates review and approval workflows, and facilitates sharing of GxP documents among employees and partners.

What is the difference between Veeva Vault and Veeva CRM? ›

Built on the Veeva Vault Platform, Vault CRM has the full functionality of Veeva CRM and significant new innovations including two new applications: CRM Bot and Service Center. Integrated into Vault CRM, CRM Bot is an intelligent assistant to help sales and medical teams be more productive.

What is the use of Veeva? ›

Veeva Systems is a global provider of industry-specific cloud solutions for the pharmaceutical, healthcare, and life science industry. The company further provides customer relationship management software, data management solutions, consulting services, administrator training, and other support to enterprises.

What is the periodic review technique? ›

With the periodic review system, you determine the quantity of an item your company has on hand at specified, fixed-time intervals (such as every Friday or the last day of every month).

What is an example of a periodic review? ›

Example: for a document with a Periodic Review Cycle of 365 days and a Periodic Review Advanced Notice of 30 days, the Next Periodic Review would be set to 335 days (365-30) from the Effective Date. On that date, the workflow would start and the approvers would be notified.

Why do pharma companies use Veeva? ›

“VEEVA allows pharma reps to share relevant material about products and services to their audience, through face-to-face calls or even remote calls, while companies utilize its tools to gain actionable insights into their interactions.”

Is Veeva Vault a quality management system? ›

Vault QMS is a system designed to manage life sciences-specific quality processes. It provides best practices for handling quality processes such as deviations, audits, and continuous improvement.

Is Veeva leaving Salesforce? ›

The long-standing partnership of Salesforce and Veeva will no longer be effective after 2025. This partnership was the cornerstone of the purpose-built solutions for the life sciences industry. This transition presents both challenges and opportunities for businesses dealing in pharmaceutical businesses.

Who competes with Veeva? ›

Top Veeva Systems Alternatives
  • SAP.
  • Oracle.
  • ComplianceQuest.
  • Honeywell (Sparta Systems)
  • Deltek (TIP Technologies)
  • MasterControl.
  • IQVIA.
  • AssurX.

What programming language does Veeva use? ›

Programmers use Veeva Clinical Query Language (CQL), designed for clinical data, to transform data for reviewers in Veeva CDB or to export data downstream.

Does Pfizer use Veeva systems? ›

Pfizer's reps are connecting with hard-to-reach HCPs via online meetings and having longer, higher quality conversations. Find out how they are using digital as part of an overall strategy to build new and deepen existing relationships. Watch a demo of Veeva CRM Engage Meeting.

What is the periodic access review process? ›

A periodic user access review is a systematic process conducted by organizations at regular intervals to evaluate and manage the access permissions granted to individuals within their information systems and resources.

What is the process validation periodic review? ›

Periodic reviews are conducted throughout the operational life of computerized system to verify that it remains in a validated state, complies with current regulatory requirements, is fit for intended use, and satisfies company policies and procedures.

What is the process of the universal periodic review? ›

The Universal Periodic Review process reviews the human rights record within a country based on three documents: 1) a report submitted by the national government of the country under review; 2) a report compiled by the Office of the UN High Commissioner for Human Rights (OHCHR) consisting of information contained in ...

What is a periodic program review? ›

Regular, periodic reviews of academic degree programs provide a formal process for thorough, fact-based documentation and evaluation of the programs, the infrastructure supporting them, and the plans for their growth and improvement.

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