QualityOne Vaults allow users to peform lab investigations for out-of-specification (OOS) and out-of trend (OOT) inspection sample test results. This feature allows users to document, standardize, and track the process of performing Phase I and Phase II lab investigations and associate records containing information about the OOS or OOT sample test result, root cause, risk assessment, corrective actions, and more.
Lab Investigations Objects
QualityOne uses the following core objects and object types to support Lab Investigations:
- Lab Investigation (
lab_investigation__v): This object represents the Phase I and Phase II lab investigation of an OOS or OOT lab result. - CAR - Lab Investigation (
car_lab_investigation__v): This object joins the Lab Investigation and CAR objects. - Lab Investigation - Inspection (
lab_investigation_inspection__v): This object joins the Lab Investigation and Inspection objects. - Material - Lab Investigation (
material_lab_investigation__v): This object joins the Lab Investigation and Material objects. - NCR - Lab Investigation (
ncr_lab_investigation__v): This object joins the Lab Investigation and NCR objects.
Configuration Overview
Configuring your Vault to use Lab Investigations involves the following steps:
- Import and configure Lab Investigations elements, including lifecycle, workflows, and object layout.
- Configure picklist options.
- Configure user permissions.
Note: Depending on your Vault’s creation date and which features are currently enabled and configured, some of the steps described in this article may be unavailable or already complete in your Vault.
Importing Lab Investigations Configuration Elements
In order to use Lab Investigations, you will need to import and deploy a configuration migration package. This package includes specially configured elements to use for Phase I and Phase II lab investigations.
Note: Contact your Veeva Representative to access the VPK to deploy the configuration.
The configuration migration package includes the following Lab Investigation configuration elements:
- Lab Investigation object lifecycle.
- Lab Investigation document type.
- Lab Investigation Phase I and Phase II workflows: guide the process for Phase I and Phase II lab investigations, including initializing, approving, and closing an investigation.
- Lab Investigation object layout: includes extensive information about the lab investigation as well as related records with additional information about the initial OOS or OOT test sample, root cause, corrective actions, and more.
These elements do not require further configuration after deploying, but you can customize them if needed.
Configuring Picklist Options
Lab Investigations comes with a set of picklists with pre-defined values, as well as some picklists you must configure by defining the values according to your organization’s business requirements:
- Sample Type (
lab_inv_sample_type__v) picklist. - Product Type (
lab_inv_product_type__v) picklist. - Impacted Areas (
lab_inv_impacted_areas__v) picklist.
Configuring User Permissions
You must ensure users have the appropriate read and create permissions to access the appropriate objects and object fields in addition to the permissions outlined below:
- Create, Edit, and Delete permissions for the following objects:
- Lab Investigation
- NCR - Lab Investigation
- Lab Investigation - Inspection
- Material - Lab Investigation
- CAR - Lab Investigation
Related Permissions
You can complete all the steps in this article with the standard System Administrator or Vault Owner security profile. If your Vault uses custom security profiles, your profile must grant the following permissions:
| Type | Permission | Controls |
|---|---|---|
| Security Profile | Admin: Configuration: Object Lifecycles: Create, Edit | Ability to create and modify object lifecycles. |
| Security Profile | Admin: Configuration: Object Workflows: Create, Edit | Ability to create and modify object workflows. |
| Security Profile | Admin: Configuration: Objects: Create, Edit | Ability to create and modify Vault objects. |