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:
- Navigate to the Entity Version layout for your Vault.
- In your custom Requirement Entity Version section, click Create.
- Select a Validation Requirement Type.
- Click Continue.
- Enter the required details.
- 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.
- Click Save. If configured by an Admin, Vault automatically populates the Name field with the appropriate naming scheme.
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
If configured by an Admin, 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:
- Navigate to the Entity Version layout for your Vault.
- 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.
- Optional: Use the drop-down on the Create button to select a different record option based on your active object types.
- 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.
- 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 configured by an Admin, 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:
- Navigate to the Entity Version layout for your Vault.
- 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.
- 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 configured by an Admin, you can import sets of requirements to a Validation Entity.
Importing Template Requirement Sets
To import requirements from a template:
- Navigate to a Validation Entity record, via Business Admin or a custom Validation Entity Version object tab.
- Perform the Import Template Requirement Sets action.
- In the dialog, select one or more Template Requirement Sets.
- Click Save.
Validation Template Managers can create Template Requirements and Template Requirement Sets for their organizations. See Managing Templates for steps to create Template Requirements and Template Requirement Sets.
Linking Requirements to Entity Families
If configured by an Admin, 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.
Note: 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 Read permission through a permission set for the Validation Requirement object can view all requirements, regardless of their Validation Team Assignment.
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 Template Requirements 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:
- Enable the Has Reference Table? field for all Validation Requirement object types.
- Add the Reference Table application section to the Design Specification, Functional Requirement, User Requirement, and Configuration Specification page detail layouts.
- 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.
Exporting Validation Requirements & Reference Tables
When configured by an Admin, Validation Management users can generate formatted output documents to export requirements and reference tables into Microsoft Word Formatted Outputs. Depending on your configuration, the generated document includes either all in-scope or requirements in the Approved state type. Generated requirement tables display a maximum of ten columns to ensure that the table fits within standard Microsoft Word document margins.
Related Permissions
To perform the tasks described in this article, you must have a security profile that includes the following permissions:
| Permission Label | Permission | Controls |
|---|---|---|
| Object: Requirement Reference Table Row | Read, Create, Edit, Delete | - Managing reference tables for requirements and specifications - Generating Formatted Output documents |
| Object: Requirements Traceability Matrix | Read, Create, Edit | - Using Quick Create - Performing the Import Template Requirement Set action - Generating Formatted Output documents |
| Object: Template Requirement | Read, Create, Edit, Delete | - Managing requirements - Performing the Import Template Requirement Set action |
| Object: Template Requirement Set | Read, Create, Edit, Delete | - Managing requirements - Performing the Import Template Requirement Set action |
| Object: Template Req - Template Req Set | Read | - Performing the Import Template Requirement Set action (if the Refactor Template Requirement setting is not enabled) |
| Object: Traceability Matrix | Read, Create, Edit | - Using Quick Create - Performing the Import Template Requirement Set action - Generating Formatted Output documents |
| Object: Unit | Read | - Managing reference tables for requirements and specifications |
| Object: Validation Activity | Read | - Generating Formatted Output documents |
| Object: Validation Entity Version | Read | - Using the Requirement Entity Version section Note: Users also require atomic security for the Requirement Entity Versions object control. |
| Object: Validation Requirement | Read, Create, Edit, Delete | - Managing requirements Using Quick Create - Performing the Import Template Requirement Set action - Managing reference tables for requirements and specifications - Generating Formatted Output documents |
| Object: Validation Req - Template Req Set | Read | - Performing the Import Template Requirement Set action (if the Refactor Template Requirement setting is enabled) - Managing reference tables for requirements and specifications |
| Object: Validation Requirement Entity Version | Read, Create, Edit, Delete | - Managing requirements - Using Quick Create - Removing records from the Requirement Entity Version section on the Entity Version layout - Performing the Import Template Requirement Set action |
| Object: Validation Requirement Reference Table | Create, Read, Edit, Delete | - Managing reference tables for requirements and specifications - Generating Formatted Output documents |