# Managing Requirements (Validation Management)

In Validation Management, Business Process Owner or System Owner users can create user requirements, functional requirements, design specifications, and configuration specifications individually or import via a templated set of requirements. This can allow your organizations to harmonize practices across departments and global sites and establish a library of commonly used requirements and specifications as new systems, equipment, processes, and other GxP systems and processes are introduced in production.

## Creating Requirements

Depending on your configuration, only certain members of a Validation Entity's Validation Team can create requirements for it. To create _Validation Requirements_:

  1. Navigate to the _Entity Version_ layout for your Vault.
  2. In your custom _Requirement Entity Version_ section, click **Create**.
  3. Select a **Validation Requirement Type**.
  4. Click **Continue**.
  5. Enter the required details.
  6. Optional: Select a **Template Requirement**. If selected, the template will populate the following fields on the requirement: _Description_, _Requirement Category_, _Requirement Source_, and _Requirement Source Details_.
  7. Click **Save**. If configured by an Admin, Vault automatically populates the _Name_ field with the appropriate <a href="/en/gr/50533906/#naming-schemes">naming scheme</a>.

The _Validation Entity Version_ field on the _Validation Requirement_ object indicates which entity version first used the requirement. Users do not need to manually enter the value for the field. Once a user associates a requirement with an entity version, Vault automatically updates the _Validation Entity Version_ field.

### Creating Requirements Using Quick Create {#quick-create}

If <a href="/en/gr/64158401/#object-setup">configured by an Admin</a>, the _Create_ button in the _Requirement Entity Version_ section allows users to initiate the creation of _Validation Requirements_ for each object type, including custom object types, with a single click.

To create a new _Validation Requirement_ using Quick Create:

1. Navigate to the _Entity Version_ layout for your Vault.
2. In your custom _Requirement Entity Version_ section, click **Create** to start a new _Validation Requirement_ record. The default object type is associated with the _Create_ button.
3. Optional: Use the drop-down on the _Create_ button to select a different record option based on your active object types. 
4. Enter the required details in the dialog, and click **Save**. The new _Validation Requirement_ record is created and associated with the appropriate _Validation Requirement Entity Version_ record. 
5. Optional: Click **Save + Create** in the dialog to save and initiate the new record for creation.

Users also can filter the columns listed in the _Requirement Entity Version_ section. Any column that includes a filter icon can be filtered, and the filter can be saved. Text, long text, and rich text fields cannot be filtered.

### Linking and Unlinking Requirements Using the Requirement Entity Version Section

If <a href="/en/gr/64158401/#object-setup">configured by an Admin</a>, the _Link Requirements_ and _Unlink Requirements_ buttons in the _Requirement Entity Version_ section allow users to quickly link or unlink one (1) or more available requirements from the entity version. Requirements that are mandatory for the entity family or are being used by a test script are not available for removal. Using the _Unlink Requirement_ button does not delete the requirement or specification record from the _Validation Requirement_ (`val_requirement_svo__v`) object but deletes the join object record between the _Validation Requirement_ and the _Entity Version_ on the _Validation Requirement Entity Version_ (`val_requirement_entity_version_svo__v`) object.

To link or unlink a requirement or specification from the _Entity Version_:

1. Navigate to the _Entity Version_ layout for your Vault.
2. In your custom _Requirement Entity Version_ section, select one (1) or more requirements or specifications from the record selector checkbox on the far left. If you want to select all, select the checkbox in the header of the checkbox column. When one (1) or more records are selected, the _Link_ button changes to an _Unlink_ button.
3. Click **Link** or **Unlink**.

## Creating Requirements from Templates

Maintaining a set of template requirements helps your organization establish an approved repository of template requirements available for use in different types of entities regardless of validation discipline. If <a href="/en/gr/50533906/#import-template-req-set">configured by an Admin</a>, you can import sets of requirements to a _Validation Entity_.

### Importing Template Requirement Sets

To import requirements from a template:

1. Navigate to a _Validation Entity_ record, via **Business Admin** or a custom **Validation Entity Version** object tab.
2. Perform the **Import Template Requirement Sets** action.
3. In the dialog, select one or more **Template Requirement Sets**.
4. Click **Save**.

Validation Template Managers can create _Template Requirements_ and _Template Requirement Sets_ for their organizations. See <a href="/en/gr/825667/">Managing Templates</a> for steps to create _Template Requirements_ and _Template Requirement Sets_.

## Linking Requirements to Entity Families

If <a href="/en/gr/64158401/">configured by an Admin</a>, you can perform the _Sync Entity Family Requirement_ action to link your requirements to an _Entity Family_. This can help you manage the qualification and validation of either identical or equivalent entities by grouping these assets under a single _Entity Family_ record.

<div class="note-border alert-info">
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      <p><strong>Note</strong>: Prior to the 25R1 release, Tag Security for Validation Management Vaults was applied only when the Family Validation feature was enabled. In 25R1, we expanded this behavior by enabling Tag Security across all Validation Management Vaults to support the use of template-related features. As a result, any Validation Management user with <em>Read</em> permission through a permission set for the <em>Validation Requirement</em> object can view all requirements, regardless of their Validation Team Assignment.</p>
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## Managing Requirements from Templates

To create new requirements in bulk, Validation Management users can download an Excel template by navigating to an _Entity_, _Entity Version_, or _Activity_ record and clicking **Download** in the _Requirements_ section. You can update existing requirements in bulk using the template by selecting the applicable requirements before clicking **Download**. Vault notifies you when the download is complete.

After making the necessary updates to the template, return to Vault and click **Upload** in the _Requirements_ section of the _Entity_, _Entity Version_, or _Activity_ to select the requirements file, then click **Start Upload**. The Excel file cannot exceed 5 MB in size. Vault notifies you when the upload is complete.

## Creating Reference Tables for Requirements & Specifications

Validation Management users can add and manage reference tables directly in requirements and specifications, allowing them to structure and maintain tabular data in a more efficient manner. You can create reference tables with up to 10 columns and 100 rows per requirement or specification. You can edit the table name and column headers, insert, edit, move, and delete rows and columns, and clone rows, along with performing table editing functionality, such as inline editing and navigating the tables through keyboard shortcuts. You can also edit and delete reference tables through the _Edit Table_ and _Delete Table_ actions, respectively.

Using the _Download to PDF_ action, you can print _Validation Entity Version_ records with all requirements and reference tables included. When you generate a PDF from a _Validation Entity Version_, if no requirements include a reference table, all requirements are consolidated into a single table. If at least one requirement contains a reference table, each requirement is exported in a separate table, with the reference table appearing immediately after the corresponding requirement. You can also export an individual requirement record as a PDF and include its reference table if present.

You can add reference tables to <a href="/en/gr/825667/">_Template Requirements_</a> to provide a predefined structure. The table does not need to be fully populated in the template. When a _Validation Requirement_ is created from the template, the reference table structure is copied, and you can easily modify the table as needed.

### Configuring Reference Tables

Admins can configure reference tables for requirements and specifications by performing the following steps:

1. Enable the **Has Reference Table?** field for all _Validation Requirement_ object types.
2. Add the _Reference Table_ application section to the _Design Specification_, _Functional Requirement_, _User Requirement_, and _Configuration Specification_ page detail layouts.
3. Optional: Add layout rules to hide the _Reference Table_ section if the requirement or specification does not have a reference table. You can use the _Has Reference Table?_ field to determine whether the requirement or specification has a table.

For the _Validation Requirement Reference_ and _Requirement Reference Table_ object lifecycles, Admins must assign all roles from the _Validation Requirement_ object lifecycle to enable role cascading to child object records. Additionally, Admins should configure lifecycle states and permissions to match those of the _Validation Requirement_ object lifecycle, ensuring that users have equivalent _Edit_ permissions at each corresponding state.

Users also must have _Edit_ permissions for the system-managed fields, such as the _Number of Columns_ field for the _Validation Requirement Reference Table_ object and the _Row #_ field for the _Requirement Reference Table Row_ object, from the permission sets and atomic security settings.

## Related Permissions

To manage requirements, a user requires a security profile or role that grants the following permissions:

* _Read_, _Create_, _Edit_, and _Delete_ permissions on the _Validation Requirement_ (`val_requirement_svo__v`), _Validation Requirement Entity Version_ (`val_requirement_entity_version_svo__v`), _Template Requirement_ (`val_template_requirement__v`), and _Template Requirement Set_ (`val_template_requirement_set__v`) objects
* To use _Quick Create_, _Read_, _Create_, and _Edit_ permissions on the _Validation Requirement_ (`val_requirement_svo__v`), _Validation Requirement Entity Version_ (`val_requirement_entity_version_svo__v`), and _Traceability Matrix_ (`val_rtm_svo__v`) objects
* To remove records from the _Requirement Entity Version_ section on the _Entity Version_ layout, _Delete_ permissions on the _Validation Requirement Entity Version_ (`val_requirement_entity_version_svo__v`) object
* To use the _Requirement Entity Version_ section, _View_ permissions for the _Requirement Entity Versions_ object control on the _Validation Entity Version_ (`val_entity__v`) object

Ensure that the following permissions are set for the _Import Template Requirement Set_ action:

- _Read_ permissions for the following objects:
  - _Template Requirement Set_
  - _Template Req - Template Req Set_ (if the _Refactor Template Requirement_ setting is not enabled)
  - _Template Requirement_ (if the _Refactor Template Requirement_ setting is not enabled)
  - _Validation Req - Template Req Set_ (if the _Refactor Template Requirement_ setting is enabled)
- _Read_, _Create_, and _Edit_ permissions for the following objects:
  - _Validation Requirement_
  - _Validation Requirement Entity Version_
  - _Requirements Traceability Matrix_

To manage reference tables for requirements and specifications, users require the following permissions:

- _Create_ and _Edit_ permissions for the _Validation Requirement_ object
- _Create_, _Read_, _Edit,_ _View_, and _Delete_ permissions for the _Validation Requirement Reference Table_ object
- _Create_, _Read_, _Edit_, and _Delete_ permissions for the _Requirement Reference Table Row_ object
- _Read_ permissions for the _Validation Req - Template Req Set_ object
- _View_ permissions for the _Unit_ object