Managing Reference Data

Vault Admins are responsible for creating and managing reference data for the departments, document categories, organizations, and products used in Vault Quality Basics. Each application uses the following reference data:

Managing Batches

You can associate affected Batches with Deviations in Quality Basics: QMS.

Creating Batches

Complete the following steps to create a new Batch:

  1. Navigate to Quality Admin > Quality Data and select Batches from the Quality Data drop-down.
  2. On the All Batches page, click Create.
  3. On the Create Batch page, enter the Batch Number.
  4. Optional: Enter the following information:
    1. Select the Product associated with the Batch. 
    2. Select the Organization of the supplier or internal facility that provided the Batch.
    3. Enter the Quantity of items contained in the Batch.
    4. Enter the Manufacture Date and Expiration Date of the Batch.
  5. Click Save. Vault creates the new Batch in the Active state.

Editing Batches

Complete the following steps to edit an existing Batch:

  1. Navigate to Quality Admin > Quality Data and select Batches from the Quality Data drop-down.
  2. On the All Batches page, click the Batch Number of the Batch you want to edit.
  3. On the Batch page, click Edit ().
  4. Edit the Batch information as needed.
  5. Click Save to save your changes.
  6. To delete the Batch, select Delete from the Actions menu, and click Continue in the confirmation dialog to confirm that you want to delete the Batch.

Managing Departments

Departments are used in the following applications:

  • Quality Basics: QMS: Used to indicate the owning department when working with Change Controls, Deviations, and Standalone CAPAs.
  • Quality Basics: QualityDocs: Used to indicate the owning department of documents.
  • Quality Basics: Training: Used when creating Learners and building the Training Matrix.

Creating Departments

Complete the following steps to create a new department:

  1. Navigate to Quality Admin > Quality Data and select Departments from the Quality Data drop-down.
  2. On the All Departments page, click Create.
  3. On the Create Department page, enter the Department Name.
  4. Optional: Enter the Department Code.
  5. Click Save. Vault creates the new department in the Active state.

Editing Departments

Complete the following steps to edit an existing department:

  1. Navigate to Quality Admin > Quality Data and select Departments from the Quality Data drop-down.
  2. On the All Departments page, click the Department Name of the department you want to edit.
  3. On the Department page, click Edit ().
  4. Edit the Department Name and Department Code as needed.
  5. From the Status drop-down, select Inactive to deactivate the department, or select Active to reactivate the department if it has been deactivated.
  6. Click Save to save your changes.

Managing Document Categories

Document Categories are used in Quality Basics: QualityDocs when creating documents.

When you create a new document, you are required to select a Document Category Type and a Document Category. The available Document Categories are dependent on the selected Document Category Type. When you create a new Document Category, you must associate it with at least one Document Category Type. Vault uses this association to determine which Document Categories are available for the selected Document Category Type when creating a document.

Creating Document Categories

Complete the following steps to create a new document category:

  1. Navigate to Quality Admin > Quality Data and select Document Categories from the Quality Data drop-down.
  2. On the All Document Categories page, click Create.
  3. On the Create Document Category page, enter the Category Name of the document category.
  4. Click Save. Vault creates the new document category in the Active state and displays the Document Category page.
  5. Expand the Document Category Types section and click Add.
  6. In the Search: Document Category Types dialog, select one or more document category types to associate with the new document category.
  7. Click OK. Vault saves the document category type associations.

Editing Document Categories

Complete the following steps to edit an existing document category:

  1. Navigate to Quality Admin > Quality Data and select Document Categories from the Quality Data drop-down.
  2. On the All Document Categories page, click the Category Name of the document category you want to edit.
  3. On the Document Category page, click Edit ().
  4. Edit the Category Name as needed.
  5. From the Status drop-down, select Inactive to deactivate the document category, or select Active to reactivate the document category if it has been deactivated.
  6. To change the document category type associations, click Add in the Document Category Types section.
  7. In the Search: Document Category Types dialog, deselect any document category types you want to remove, select any additional document category types you want to add, and click OK. Vault saves your changes to the document category types.
  8. Click Save. Vault saves your changes to the document category.

Managing Organizations

Organizations are used in the following Vault Quality Basics applications:

  • Quality Basics: QMS: Used to indicate the owning facility when working with Change Controls, Deviations, and Standalone CAPAs.
  • Quality Basics: QualityDocs: Used to indicate the owning facility of documents.
  • Quality Basics: Training: Used when creating Learners.

Creating Organizations

Complete the following steps to create a new organization:

  1. Navigate to Quality Admin > Quality Data and select Organizations from the Quality Data drop-down.
  2. On the All Organizations page, click Create.
  3. In the Create Organization dialog, select the Organization Type from the drop-down and click Continue.
  4. On the Create Organization page, enter an Organization Name for the organization.
  5. Optional: Enter the Legal Name of the organization and any necessary contact information.
  6. Optional: For Suppliers and Supplier Sites, select the Type of supplier from the drop-down.
  7. For Supplier Sites, select the parent supplier from the Parent Organization drop-down, which displays all organizations with the Supplier type.
  8. Click Save. Vault creates the new organization in the Initiated state.

Editing Organizations

Complete the following steps to edit an existing organization:

  1. Navigate to Quality Admin > Quality Data and select Organizations from the Quality Data drop-down.
  2. On the All Organizations page, click the Organization Name of the organization you want to edit.
  3. On the Organization page, click Edit ().
  4. Edit the Organization Name and any other information as needed.
  5. From the Workflow Actions menu, select Mark as Retired if you want to indicate that the organization is retired, and click Start in the Start dialog to confirm that you want to change the organization to the Retired state.
  6. From the Workflow Actions menu, select Reopen Organization if you want to reopen an organization that was previously retired, and click Start in the Start dialog to confirm that you want to change the organization back to the Initiated state.

Managing Products

Products are used in the following Vault Quality Basics applications:

  • Quality Basics: QMS: Used to indicate the impacted products when working with Change Controls.
  • Quality Basics: QualityDocs: Used to indicate the product when creating new documents.

Creating Products

Complete the following steps to create a new product:

  1. Navigate to Quality Admin > Quality Data and select Products from the Quality Data drop-down.
  2. On the All Products page, click Create.
  3. On the Create Product page, enter the Product Name.
  4. Optional: Enter the Product Abbreviation.
  5. Click Save. Vault creates the new product in the Active state.

Editing Products

Complete the following steps to edit an existing product:

  1. Navigate to Quality Admin > Quality Data and select Products from the Quality Data drop-down.
  2. On the All Products page, click the Product Name of the product you want to edit.
  3. On the Product page, click Edit ().
  4. Edit the Product Name and Product Abbreviation as needed.
  5. From the Status drop-down, select Inactive to deactivate the product, or select Active to reactivate the product if it has been deactivated.
  6. Click Save to save your changes.

Managing Root Cause Categories

You can select the associated Root Cause Category when documenting root cause information for Deviations in Quality Basics: QMS.

Creating Root Cause Categories

Complete the following steps to create a new Root Cause Category:

  1. Navigate to Quality Admin > Quality Data and select Root Cause Categories from the Quality Data drop-down.
  2. On the All Root Cause Categories page, click Create.
  3. On the Create Root Cause Category page, enter the Category Name.
  4. Click Save. Vault creates the new Root Cause Category in the Active state.

Editing Root Cause Categories

Complete the following steps to edit an existing Root Cause Category:

  1. Navigate to Quality Admin > Quality Data and select Root Cause Categories from the Quality Data drop-down.
  2. On the All Root Cause Categories page, click the Category Name of the Root Cause Category you want to edit.
  3. On the Root Cause Category page, click Edit ().
  4. Edit the Category Name as needed.
  5. Click Save to save your changes.
  6. To delete the Root Cause Category, select Delete from the Actions menu, and click Continue in the confirmation dialog to confirm that you want to delete the Root Cause Category.

Managing Root Cause Sub-Categories

You can select the associated Root Cause Sub-Category when documenting root cause information for Deviations in Quality Basics: QMS.

Creating Root Cause Sub-Categories

Complete the following steps to create a new Root Cause Sub-Category:

  1. Navigate to Quality Admin > Quality Data and select Root Cause Sub-Categories from the Quality Data drop-down.
  2. On the All Root Cause Sub-Categories page, click Create.
  3. On the Create Root Cause Sub-Category page, enter the Sub-Category Name.
  4. Select the Category associated with the Root Cause Sub-Category.
  5. Click Save. Vault creates the new Root Cause Sub-Category in the Active state.

Editing Root Cause Sub-Categories

Complete the following steps to edit an existing Root Cause Sub-Category:

  1. Navigate to Quality Admin > Quality Data and select Root Cause Sub-Categories from the Quality Data drop-down.
  2. On the All Root Cause Sub-Categories page, click the Sub-Category Name of the Root Cause Sub-Category you want to edit.
  3. On the Root Cause Sub-Category page, click Edit ().
  4. Edit the Sub-Category Name as needed.
  5. From the Status drop-down, select Inactive to deactivate the Sub-Category, or select Active to reactivate the Sub-Category if it has been deactivated.
  6. Click Save to save your changes.
  7. To delete the Root Cause Sub-Category, select Delete from the Actions menu, and click Continue in the confirmation dialog to confirm that you want to delete the Root Cause Sub-Category.

Managing Studies

You can associate affected studies with Deviations in Quality Basics: QMS.

Creating Studies

Complete the following steps to create a new Study:

  1. Navigate to Quality Admin > Quality Data and select Studies from the Quality Data drop-down.
  2. On the All Studies page, click Create.
  3. On the Create Study page, enter the Study Number.
  4. Optional: Enter the Study Name.
  5. Click Save. Vault creates the new Study in the Active state.

Editing Studies

Complete the following steps to edit an existing Study:

  1. Navigate to Quality Admin > Quality Data and select Studies from the Quality Data drop-down.
  2. On the All Studies page, click the Study Number of the Study you want to edit.
  3. On the Study page, click Edit ().
  4. Edit the Study information as needed.
  5. Click Save to save your changes.
  6. To delete the Study, select Delete from the Actions menu, and click Continue in the confirmation dialog to confirm that you want to delete the Study.