The creation of a new Organization begins with a "basis for creation" regular/enriched email message/notification with the topic "New Organization":

• regular/enriched email message with an attachment "Decision to introduce a new Organization".
• enriched email notification automatically sent after the creation of the new Substance
• enriched email notification sent during the creation of the Marketed Substance Production Chain
• enriched email notification sent from the Enriched Email Client to create a new contact/Organization

Other entity definition documents that may be necessary for the structural and narrative definition of an Organization are:

Gathering of documentation and necessary data for the structural and narrative definition of a new Organization can be done in advance, before the beginning of structural definition and subsequently when the Organization has become a topic in the enriched email correspondence.

Previously received attachments/documents have to be manually assigned to the corresponding replacement files using the application form "Corporate Entity creation / Organization / Narrative data". The process is explained in the narrative definition section.

All correspondence from then on should be conducted using enriched email messages and the newly-created Organization as the topic.

During the subsequent correspondence and classification of the attachment(s), attached document(s) are automatically uploaded to the Corporate Documentation Cloud and assigned to the appropriate replacement files.

If necessary, additional correspondence using the "New Organization" topic and subtopic "related correspondence" can be made in order to clarify certain details. When all details are clarified, the structural definition process can be started by choosing the menu item "Corporate Entity creation / Organization / Structural Data" on the "Corporate Entities" application module.

To create a new Organization, first, using the "Correspondence" sub-application form, a received "basis for creation" enriched email relevant to the new Organization being created must be selected from the non-processed correspondence documents. In addition, all enriched email messages classified as "related correspondence" pertaining to the same new Organization, should also be selected in order to properly establish entity creation correspondence environment.

The structural data of an Organization are defined using:

• free text fields for "Full name", "Short name" and "Alternative name"
• free text fields for "Address1", "Address1", "Address1", "Address1", "County", "State", "Zip code", "email", and "webpage"
• predefined List of Values (LoV) for Cities and Countries
• selection block for "Type of organizational unit"
• List of Values for a designated cmc entity person
• free text fields for "ORG-ID", "LOC-ID", "D.U.N.S. No.", and "Eudra GMDP"
• selection block for "Legal position" with three options related to Corporation
  • Legal position within the Corporation with LoV "Superior Legal Entity"
  • Legal position with the Corporation with LoV  "Legally connected Corporate Entity"
  • Not legally connected with selection block

Mandatory fields required for the insertion of a record into the eCTD Integral Information System are denoted with (*).

When the minimal structural data set criterion is met and the Organization is introduced into the eCTD Integral Information System, a core sequence, directory tree of replacement narrative files, and a enriched email notification to the designated cmc entity person are generated.

During subsequent correspondence and classification of attachment, the attached document(s) are automatically uploaded to the Corporate Documentation Cloud and assigned to the appropriate replacement narrative files.

Contacts persons of the Organization are defined on the sub-application form that is activated by clicking the button "New/Edit Contact person".

First general data are entered in the free text fields and eCTD dir/file name is automatically generated to uniquely identify contact person CV.

Areas of expertise of the contact person are defined using LoV with pre-defined business functions, disciplines and sub-disciplines. The contact person is always the top level/main person of the business function of the given Organization, so their superior corporate managers are always from other Organizations of that corporation. In this way, the separate corporate hierarchical structures of corporation business functions and disciplines are defined, which do not depend on the functional hierarchical structure of corporate organizations. Each contact person may have several areas of expertise and may have a separate superior corporate manager for each.

The internal hierarchical structure of functional organizational units of each Organization with business functions, disciplines and sub-disciplines is defined in the Human Resources application module which can be added to the eCTD Integral Information System upon request.

The definition of GxP structural data of an Organization is sectioned in three parts:

• Definition of GMP structural data of Medicinal Product manufacturer
• Definition of structural data of GDP of the distribution organization
• Definition of structural data of GMP of the Active Product Ingredient (API) manufacturer 

The structural definition process can be completed in two ways:

1. In one instance/session when all structural data are defined
2. in several instances/sessions where
   1. in the first session only minimal data set and maybe some of the additional data are defined
   2. in the  next session(s) remaining additional data are defined

The designated cmc entity person is responsible for the complete narrative definition of the Organization.

Using any regular text processor eCTD documents have to be created and pdf files generated for uploading to the Corporate Documentation Cloud. If required, the process of verification by a senior manager can be included upon request.

The process is initiated by choosing the menu item "Corporate Entity creation / Organization / Narrative Data" on the "Corporate Entities" application module.

By clicking on the "Upload eCTD file" button, the file is uploaded to the Corporate Documentation Cloud.

By clicking the "View eCTD file" button, the file can be open for review.

When all the presented replacement files in the directory tree are replaced with written eCTD files, the process ends automatically and the Organization is set to be "completely structurally and narratively defined".