Non-eCTD submissions, including veterinary and medical device submissions, often share validation criteria with similar themes, but different requirements. For example, a file’s size cannot exceed 10MB for some regions, but can be up to 50MB, 100MB, or 500MB for others. Configurable validation criteria allow your organization to create Publishing Validation Criteria records for each of these variations in regional requirements, specifying the individual region’s requirement as a Parameter. Vault then uses the regional Parameter value to determine whether a given Content Plan Item is valid during continuous validation, continuous publishing, and on-demand-publishing and validation.
Note: This feature is only available on RIM Submissions Publishing Vaults and must be configured by an Admin.
Configuring Validation Criteria
Configurable validation criteria rely upon Publishing Validation Criteria records to define validation Parameters for each region, as well as supporting Controlled Vocabulary and Constraint records which define the validation criteria version.
To leverage configurable validation criteria, your Vault must have the following:
- One Controlled Vocabulary record for Non-eCTD Validation (the record Name), with the CV Value Filter field set to Validation Criteria Version and Controlled Vocabulary Type set to DTD XSD Version.
- One Constraint record associated with the above Non-eCTD Validation Controlled Vocabulary record via the CV_4 field.
- One Publishing Validation Criteria record for each regional criteria, as defined in the Parameter field. The record must also correspond to the Controlled Vocabulary record for that criteria version via the Validation Criteria Version field.
Example Publishing Validation Criteria
The Health Authorities for the following countries each require that a given published document does not exceed a certain size:
- Switzerland: 200MB
- Canada: 100MB
To support these validation criteria, a Business Admin creates two (2) Publishing Validation Criteria records for the validation criteria rule which verifies file size (VRSP0020) with the following metadata:
| Number | Country | Vault RIM Validation Criteria ID | Parameter | Validation Criteria Version |
|---|---|---|---|---|
| CH001 | Switzerland | RuleVRSP0020 | 200 | Non-eCTD Validation - Switzerland |
| CA001 | Canada | RuleVRSP0020 | 100 | Non-eCTD Validation - Canada |
Configurable Validation Criteria Results
When Vault validates a non-eCTD submission using configured validation criteria, it compares the configured Parameter against a Content Plan Item record’s Published Output Location value in most cases. Conversely, when Vault validates an eCTD submission, it reviews the corresponding index/regional XML document.
The sections below provide further detail for the conditions under which a Content Plan Item passes or fails validation, as well as when Vault skips validation.
Failure Results
The table below describes each configurable validation criteria, with an example Parameter and the error message users receive when the rule fails.
During validation, Vault also verifies that the Publishing Validation Criteria record’s Parameter value is numeric (0-9) or, for RuleVRSP0024, ASCII special characters (for example, & # \ !) only. Configured validation rules fail when a Parameter value contains unsupported characters, including spaces.
| Vault RIM Validation Criteria ID | Description | Example Parameter | Example Failure Description |
|---|---|---|---|
| RuleVRSP0020 | The file size exceeds the allowed value. | 100 | The published document size (200MB) exceeds the allowable size (100MB) |
| RuleVRSP0021 | The file path length exceeds the allowed value. | 164 | The published document’s path length (167: [current path with 167 characters]) exceeds the allowable length (164) |
| RuleVRSP0022 | The folder name length exceeds the allowed value. | 50 | The published document’s folder name length (65: [current folder name with 65 characters]) exceeds the allowable length (50) |
| RuleVRSP0023 | The file name length exceeds the allowed value. | 50 | The published document’s file name length (79: [current file name with 79 characters]) exceeds the allowable length (50) |
| RuleVRSP0024 | The file path contains invalid characters. | %$\? | Invalid characters in the file path: [ % ] [ $ ] [ \ ] [ ? ] |
Skip & Pass Results
- Rule VRSP0020: Vault skips validation when a Content Plan Item does not have a published document.
- Rules VRSP0021 through VRSP0024: Vault skips validation when a Content Plan Item’s Published Output Location field is blank.
Vault passes validation for all Content Plan Items which meet the Parameter criteria, or if the Publishing Validation Criteria record’s Parameter value is blank.
Equivalent eCTD Validation Criteria
The configurable criteria Vault uses to validate non-eCTD submissions correspond to the below eCTD Publishing Validation Criteria records already available in your Vault:
| Description | Configurable Validation Criteria | Examples of corresponding predefined eCTD Rule (Vault RIM Validation Criteria ID) |
|---|---|---|
| File size | RuleVRSP0020 | Rule1238 |
| File path length | RuleVRSP0021 | Rule1085 |
| Folder name length | RuleVRSP0022 | Rule15.5 |
| File name length | RuleVRSP0023 | Rule1221 |
| Invalid characters in the file path | RuleVRSP0024 | Rule1102 |