# Generating an eCTD Compliance Package You can use an _eCTD Compliance_ binder and connected promotional pieces to generate an FDA Form 2253 from within Vault. Vault automatically populates the form using field values from the binder and from connected documents. With the [correct configuration](/en/lr/65733/), Vault can generate the supplementary sheet required for multi-product 2253 submissions. You must use XFA form mapping in order to utilize the FDA's 2253 form. When you create an eCTD Compliance Package, Vault automatically generates a new Compliance Package with _Submission Ready Copies_ of documents and converts Vault link annotations to relative PDF links. ## Preparing to Generate a Package Before generating a Compliance Package and submitting it to the FDA, you'll want to verify that your references and promotional materials are in order. "Promotional material" refers to the material you perform the _Create Post Marketing Compliance Package_ or the _Create Pre Clearance Compliance Package_ action on. On your promotional material: * Ensure that any necessary [Vault link annotations](/en/lr/15303/) are on the document versions to be included. * Verify that the following fields are populated on all documents: * _Material Type_ * Professional/Consumer * Dissemination/Publication Date * _Submission Required_ is set to **Yes** and that the _Health Authority_ is set to **FDA 2253** or **FDA 2253 Preclearance**, as applicable * Determine which reference documents must be included, and delete any that are unnecessary. For example, if you deleted a Vault link annotation from a document, and the reference document is now unused, you can delete the reference document from the _Linked Document_ section to prevent it from being copied into the Compliance Package. * Ensure that the correct version of any relevant [supporting documents][1] are included, and delete any that are unnecessary. * Upload any additional Clean Version documents in a ZIP file using the [_eCTD Submission Package_](/en/lr/65733/#ectd-rendition-type) rendition type. * In the _Linked Documents_ section, verify that the PI labeling material is linked to the correct version of the promotional pieces as [linked document or Vault link annotation](/en/lr/15303/). Vault copies the PI labeling material to the _1.14.6 Product Labelling_ section of the package, and any link annotations to the _1.15.2.1.3 Annotated Labeling Version_ section. * Verify that the only documents linked to the promotional material via a _Linked Document_ relationship and/or the _eCTD Support Documents_ relationship are the ones you want copied into the Compliance Package. * Ensure that all anchors linking to the promotional piece are in the same version of the reference/PI labeling material. If they aren't, Vault will not convert some of the anchors to destinations in the binder. * On the _Dosage_ and _Indication_ objects, verify that an Admin has created records for the products included in the Compliance Package. This only applies if you are generating a Preclearance Compliance Package. ### Adding Extra Documents to Compliance Packages {#adding-supporting-documents} To add supporting documents like certificates of translation or reviewer instructions to the Compliance Package, upload the documents to Vault classified as the Supporting Document type and one of the following subtypes: * _eCTD Compliance Clean Material_ * _eCTD Compliance Annotated Material_ * _eCTD Compliance Annotated Label_ * _eCTD Compliance Annotated Reference_ Then, create an **eCTD Support Documents** type document relationship between the supporting document and the relevant material included in the bulk action. Vault pulls Supporting Documents into the binder even if **Linked References** equals **No** on the Compliance Package.
Vault generates the submission ready versions of supporting documents when you add them to an eCTD Package as follows: | Original Document Subtype | Submission Ready Version Document Type | eCTD Package Folder | | --- | --- | --- | | eCTD Compliance Clean Material | Clean Material | Clean Version | | eCTD Compliance Annotated Material | Annotated Material | Annotated Version | | eCTD Compliance Annotated Label | Annotated Label | Annotated Labeling Version | | eCTD Compliance Annotated Reference | Annotated Reference | Annotated References |
You can add many Clean Version documents, including video and audio files, to one material folder in the Compliance Package by compressing the documents into a ZIP file and adding them to the promotional material with the _eCTD Submission Package_ rendition type. You can then [generate][2] or [regenerate][3] the Compliance Package, and PromoMats unzips the _eCTD Submission Package_ and adds all of the included documents to the Clean Version folder.  Another option for including a video or audio file as an extra document in a Compliance Package is to use the _Final Video/Audio_ rendition type. Add the video or audio file to the storyboard using the rendition type and then generate the Compliance Package, using the storyboard along with the other documents you need to submit. ### Preparing to Generate Multiple Compliance Packages {#bulk-prep} Before generating multiple Compliance Packages, you'll want to verify that your documents are in order and that required fields are populated. This allows Vault to correctly validate documents. On your documents, verify that: * The _Product_ field is populated with at least one (1) value. * At least one value in the _Product_ field is associated to a United States _Application_ * The _Professional / Consumer_ field is populated and is set to either _Professional_ or _Consumer_ * The _Health Authority Submission_ field is set to either _FDA 2253_ or _FDA 2253 Accelerated Approval_ * The document type is not _eCTD Submission Ready Documents_, _Supporting Documents_, or _Health Authority Form_ When available, Vault automatically populates most Compliance Package metadata during bulk generation using from the following locations in the system: | Compliance Package Field | Default Data & Location | | --- | --- | | _Name_ | The custom naming format defined in your Vault's [document type configuration](/en/lr/618/) | | _Product_ | The _Product_ field on the promotional material | | _Secondary Brands_ | The _Product_ field on the promotional material | | _Application_ | Any United States _Application_ associated to the primary product | | _Secondary Brands Application_ | Any United States _Application_ associated to secondary products where the _Application_ type matches that of the primary _Application_ | | _Professional / Consumer_ | The _Professional / Consumer_ field on the promotional material | | _Compliance Package Type_ | The _Health Authority Submission_ field on the promotional material | | _Country_ | Defaults to _United States_ | | _Responsible Official_ | The _Responsible Official_ field on the primary _Application_ object record | You must manually populate the following fields: * _Correspondence Letter_ * _Submission Date_ * _Reg Comments to FDA_ * _Promotional Material Document Type_* * _Launch Material Type_ * _Dosage_ * _Indication_ * Any custom fields \* The _Promotional Material Document Type_ must be manually populated on Preclearance packages. Vault automatically populates the field on Post Marketing packages. ## Generating the Compliance Package {#generating} To generate a Compliance Package: 1. Select the appropriate documents. 2. Click the **Actions** menu and initiate a [**bulk action**](/en/lr/18822/). 3. On the **Refine Selection** page, select the promotional pieces you want to use to create the eCTD Compliance Package. 4. Click **Next**. 5. Under _Generate Compliance Package_, select which package to generate. 6. Click **Next**. 7. On the **Edit Details** page, complete the required fields. 8. Select **Yes** or **No** under _Include Linked References_ to determine whether Vault creates relative PDF links. 9. Click **Next**. 10. On the **Confirmation** page, check that the information displayed is correct. 11. Click **Finish**. Vault notifies you after Compliance Package generation is complete. The process may take several minutes to complete. PromoMats does not submit the Compliance Package to the FDA. You'll need to move the generated Compliance Package through its workflow for review and approval. Then, you can export the generated Compliance Package to a separate publishing tool to submit it to the FDA. You can then mark the binder as _Submitted_ in PromoMats. Organizations with a PromoMats and a RIM Vault can configure a standard [Vault to Vault connection](/en/lr/72311/), enabling seamless flow from compliance package generation in PromoMats to package submission in RIM.
### Generating Multiple Compliance Packages {#bulk-gen} [When configured](/en/lr/65733/#bulk-gen-config), you can also generate multiple eCTD Compliance Packages at once.
Vault automatically groups documents based on the following fields: * _Product_ * _Professional / Consumer_ * _Health Authority Submission_ To generate multiple Compliance Packages at once: 1. Select the appropriate documents. 2. Click the **Actions** menu and initiate a [**bulk action**](/en/lr/18822/). 3. On the _Refine Selection_ page, select the promotional pieces you want to use to create the eCTD Compliance Packages. Then, click **Next**. 4. Under _Generate Compliance Package_, select **Create eCTD Compliance Packages**. Then, click **Next**. 5. Vault may indicate where there are [validation errors](/en/lr/583855/). If there are, exit the action to resolve the error and then try again. 6. If prompted, select the **Primary Product** for each group. Vault prompts you to select the primary product if a document in the selection includes more than one (1) product or if more than one (1) product is associated with a US application. 7. Select a **Primary Product** to apply in bulk and click **Apply**. This bulk change only applies to groups containing the selected product. For example, if you select _Cholecap_ for some groups and _WonderDrug_ and _Natevba_ for others, selecting _WonderDrug_ as the main _Primary Product_ only applies to the _WonderDrug_ groups. 8. Click **Next**. 9. On the _Preview Compliance Packages_ page, review and edit package details. If present, click to complete any blank required fields. 10. Click **Next**. Vault notifies you once all of the selected Compliance Packages are generated. The process may take several minutes to complete. ## Correcting Errors & Troubleshooting the Compliance Package {#correctingerrors} After generating Compliance Packages, you can review the binders and make changes to the components, such as the 2253 or Supplementary Forms or relative PDF links.You can also troubleshoot any validation errors encountered during bulk generation. For more information on package generation errors, see [Correcting Errors in eCTD Compliance Packages](/en/lr/583855/). ## Exporting the Compliance Package After the eCTD Regulator approves the binder, the _Compliance Package Publisher_ can perform the **Export Compliance Package** user action, download the ZIP file, and extract the documents. The Compliance Package Publisher can then import the documents into a RIM Publishing Vault. To import the Compliance Package to RIM Publishing Vault: 1. Upload the ZIP file into a RIM Publishing Vault. 2. Create a **Submission Content Plan**. 3. Match documents from the Compliance Package to the content plan structure. 4. Using RIM Publishing, prepare the content for submission to the FDA. If you need to edit the package content while working in the RIM Publishing Vault, you'll need to return to PromoMats, move the binder to the _Revise and Resubmit_ state, and [update the contents](/en/lr/65734/#correctingerrors). When the package is finalized for submission in RIM Publishing, you can submit the package to the FDA. After submitting the Compliance Package, return to your PromoMats Vault and move the binder to the _Submitted_ state. You'll also need to move the promotional material to the _Steady_ state. ## Compliance Package Components Vault includes the following documents in each package: | Package Type | Documents Included | | --- | --- | | Post Marketing Compliance Package | 2253 form
Supplementary form if there is more than one product
Product Labelling material
Clean Material
Metadata.xml

_If references are included:_
Annotated Material
Annotated Label
Annotated Reference| | Preclearance Compliance Package (Center APLB) | 2253 form
Supplementary form if there is more than one product
Product Labelling material
Clean Material
Metadata.xml
Correspondence Letter

_If references are included:_
Annotated Material
Annotated Label
Annotated Reference | | Preclearance Compliance Package (Center OPDP) | Product Labelling material
Clean Material
Metadata.xml
Correspondence Letter

_If references are included:_
Annotated Material
Annotated Label
Annotated Reference |
The binders include new copies of the specified documents rather than the exact documents selected. ## Related Permissions {#related-permissions} The following [permissions](/en/lr/22824/) and [document type and role permissions](/en/lr/2572/) now control the ability to work with eCTD Compliance Packages. You must apply the document role permissions to states in the lifecycle your promotional material is using. By default, this is the _Material_ lifecycle. | Type | Permission Label | Controls | | --- | --- | --- | | Security Profile | Object: Center: Read | Ability to create the eCTD Compliance Package. | | Security Profile | Object: Promotional Material Document Type: Read | Ability to create the eCTD Compliance Package. | | Security Profile | Object: Indication: Read | Ability to create Preclearance eCTD Compliance Packages. This permission is optional. | | Security Profile | Object: Dosage: Read | Ability to create Preclearance eCTD Compliance Packages. This permission is optional. | | Security Profile | Object: Product Indication Join: Read | Ability to create the eCTD Compliance Package. | | Security Profile | Object: Indication: Edit | Ability to edit the _Indication_ object and create object records. | | Security Profile | Object: Dosage: Edit | Ability to edit the _Dosage_ object and create object records. | | Security Profile | Object: Product Indication Join: Edit | Ability to edit the _Product Indication Join_ object and create object records. | | Document Type | eCTD Submission Ready Documents: Create Binder | Ability to create eCTD Submission Ready Document binders. | | Document Role | Material: View Content | Ability to generate the eCTD Binder and all applicable documents when linked references (relative PDF links) are included. Add this permission to the state the document is in when the bulk action is performed to create the eCTD binder. | | Document Role | eCTD Submission Ready Documents: Download Source | Ability to export the compliance package. | | Document Role | Edit Document | Ability to add documents to the binder and regenerate the Compliance Package. | | Document Role | Version | Ability to add documents to the binder and regenerate the Compliance Package. | [1]: #adding-supporting-documents [2]: #generating [3]: #correctingerrors