Corporate Documentation

  • Corporate Correspondence

    • Enriched Email Correspondence

    • Regular Email Correspondence

  • Corporate Documents

    • Corporate entity documents

    • Corporate project documents

    • Corporate Documents Identification and Classification

Corporate Documentation is the property of the Pharmaceutical Corporation and can be used for business purposes for the benefit of the Pharmaceutical Corporation.

The basic assumption of the eCTD Integral Information System is that all correspondence and documents are in the electronic form and can be therefore stored in the eCTD Integral Information System Database or uploaded in the Corporate Documentation Cloud.  Based on that assumption Corporate Documentation is classified in two major classes:

  • Corporate Correspondence - stored in the eCTD Integral Information System Database and consisting of electronic emails of:
    • enriched email messages
    • enriched email notifications
    • regular email messages
  • Corporate Documents - stored in the Corporate Documentation Cloud and consisting of electronic document files containing narrative and/or multimedia data. Links to Corporate Documents stored in the Corporate Documentation Cloud are stored in the eCTD Integral Information System Database

Corporate Documentation is related to either Corporate Entities or Corporate Projects and is either generated within the Pharmaceutical Corporation or received from Health Authorities or other Health Institutions and Business Partners.

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It i important to note that Enriched Email links Corporate Correspondence and Corporate Documents together, relates them to a Corporate Entity or Corporate Project, and creates the foundation of the eCTD Integral Information System.

There are two types of Corporate Correspondence:

  • enriched email correspondence
    • enriched email messages
    • enriched email notifications
  • regular email correspondence
    • regular email messages

Both types, enriched email messages/notifications and regular email messages, are processed with the Enriched Email Client and stored in the Classical Email Server and the Relational Email Server.

Enriched email message attachments are Corporate Documents and as such are stored in the Corporate Document Cloud, while links to them are stored in the eCTD Integral Information System Database.

Enriched Email Correspondence

Enriched email correspondence consists of:

  • Enriched email messages
  • Enriched email notifications

Each enriched email message/notification is a part of the Corporate Documentation that cannot be deleted or changed by the recipient or originator.

As each enriched email message/notification is a part of Corporate Documentation, it can be a part of various reviews and reports, and as such, its content and attachments can be seen by other corporate users depending on system privileges and business rules of the eCTD Integral Information System. Each enriched email message/notification is associated with either one Corporate Entity and one of its development/subtopics or one Corporate Project and one of its activity/significant event combinations.

Enriched email messages

Enriched email messages are either generated or received and registered by corporate users and are always related to one of the  Corporate Entities or one of the Corporate Projects.

Attachments of enriched email messages are Corporate Documents and part of the Corporate Documentation.  After classification and registration they are automatically uploaded to the Corporate Documentation Cloud.

Processing of incoming regular email messages

Unprocessed regular email messages delivered to a designated person are also delivered to the designated person's Agent, and any of them can process and enrich the messages and classify their attachments. Upon registration, the Assistant and followers by choice are automatically delivered forwards of the enriched email message.

Replies to enriched email messages delivered to a designated person are also delivered to his appointed Agent and his topic-appointed Assistant, each of whom may also enrich regular email messages and classify attachments. Upon registration, the followers by choice are delivered automatically generated forwards of the enriched email messages.

Writing enriched email messages

A designated person, his Agent and/or his Assistant can write enriched email messages regarding the topic they are appointed to follow. Others, including followers by choice, are delivered a copy of the messages.

Followers by choice may write enriched email messages related to the topic they follow, but may only use related correspondence as a subtopic and related documentation as an attachment.

The classification of attachments is entity subtopic or project activity dependent. For each class of subtopics of Corporate Entities and activities of Corporate Projects, document classes are defined. All document classes can be further customized per corporate needs.

It is important to note that each attachment is classified, identified and independently and directly associated to either one of the Corporate Entities and their subtopic or to Corporate Projects and their activity/significant event combinations, so that they can be used individually as part of reviews and reports without any reference to enriched email messages by which they were sent or received.

Enriched email notifications

Enriched email notifications are automatically generated as a consequence of a significant event. The distribution list of each enriched email notification is generated using business rules stored in the eCTD Integral Information System Database. For example:

  • an enriched email notification generated upon the complete definition of the Marketed Substance Production Chain of an active substance is sent directly to the cmc entity person in charge of defining the Medicinal Product Preparation Production Chain of the same active substance. In the absence of such a person, an enriched email notification is sent to the cmc entity person of the highest level.

Each enriched email notification carries with it structural information that is later used on one of the application forms of the eCTD Integral Information System. For example:

  • an enriched email notification for the introduction of the first Pre-Clinical Tests, generated automatically after the introduction of a new Innovative active substance, carries the ID  of the Substance whose introduction generated notification
  • an enriched email notification for the introduction of a new Investigational Medicinal Product Preparation Chain generated automatically after the introduction of a new Investigational Medicinal Product, carries the ID  of the active substance and the ID of the Lead Sponsor of the Clinical Trial for which the Investigational Medicinal Product is intended

It is important to note that enriched email notifications use various business rules and carry, in addition to narrative information, structural information that is later used to provide many features of the eCTD Integral Information System. By using messages initiators and correspondence chains, the structural information of many steps backward is used on the application forms of the eCTD Integral Information System.

Regular Email Correspondence

Regular email messages are not linked with the Corporate Entities or Corporate Projects and therefore can not be used in a combination with other enriched email messages to create reviews or reports for corporate users. The regular email messages can only be seen by their correspondents and cannot be used or seen by other corporate users. Attached documents are not automatically uploaded to the Corporate Documentation Cloud, and can not be viewed by other corporate users or be part of numerous reviews or reports.

Processing of incoming regular email messages

During processing, regular email messages are declared private and, as such, do not belong to the Corporate Documentation.

Writing regular email messages

Any corporate user can write regular email messages that are declared private by default and do not belong, along with their attachments to the Corporate Documentation.

It is important to note that a corporate user alone decides whether to register an incoming regular email message or to write a enriched or regular email message, thus being the only one who decides when to share the information contained in the email message with other non-participants in the correspondence. 

There are two types of Corporate Documents:

  • Corporate entity documents - related to Corporate Entities and their development/subtopics activities
  • Corporate project documents - related to Corporate Projects and their activity/event combinations.

For Corporate Documents identification and classification purposes, a parallel system is used, consisting of strong identification with an ID number for each document and multiple classifications related to several business areas. 

All Corporate Documents are uploaded and stored in the Corporate Documentation Cloud.

Using corporate entity definition documents and corporate project documents, project initial submissions are generated representing the documentary basis for the realization of Corporate Projects. The same corporate entity definition documents can be a part of several types of project initial submissions. The corporate project documents are used only once, during the realization of a specific Corporate Project for which they were created.

Using legislative eCTD and corporate directory templates for each project initial submission type, the directory trees with replacement documents consisting of both Corporate Document types are defined and stored in the eCTD Integral Information System Database. At the beginning of the Corporate Projects, they are automatically generated and completed with joint effort of the corporate entity and corporate project persons.

Corporate Entity Documents

Corporate entity documents are mainly generated during the corporate entity development/subtopic activities, either in connection with the creation of a new Corporate Entity, its further development or its substantial changes.

Corporate entity documents are created or received via enriched/regular email messages by the designated corporate entity person, his Agent and/or his Assistant.

Corporate entity documents are classified in the following categories:

  • entity related documents
  • entity definition documents

Entity related documents

Entity related documents are general documents which are not predefined in terms of content and purpose. Those documents are created and exchanged via regular/enriched email messages during the development/change phases of Corporate Entities.

Entity definition documents

Entity definition documents are predefined in terms of their content and purpose by eCTD and corporate templates. They serve to narratively define the newly created Corporate Entities or to define their substantial changes. Those documents are classified with respect to the corporate entity characteristics defined for each type of Corporate Entity. They are created by a designated person, his Agent, and/or his Assistant and are manually uploaded to the Corporate Documentation Cloud.

It is important to note that all entity definition documents are part of one or more types of project initial submissions that represent the documentary basis for the realization of Corporate Projects. The modular structure of Corporate Entities makes such an approach possible and enables the automatic generations of project initial submissions.

Corporate Project Documents

Corporate project documents are Corporate Documents created during the realization of Corporate Projects and their activities.

Corporate project documents are classified in the following categories:

  • project initial/related submission documents
  • project related documents

Project initial/related submission documents

Directory trees with replacement documents for the project initial/related submissions are automatically generated. They consist of project initial/related submission documents and entity definition documents.

The project initial/related submission documents are:

  • created and manually uploaded by corporate project person(s), their Agents and/or their Assistants or
  • received by corporate project person(s), their Agents and/or their Assistants via regular/enriched email messages from corporate entity persons of other business functions

Project related documents

Project related documents are defined for each class/type of Corporate Projects. They are classified with respect to the project activities and their significant events defined for each class/type of Corporate Projects. Each project significant event is accompanied by a project related document.

It is important to note that all project related documents are created either locally or received from Health Authorities and/or Business Partners by the corporate project person. Their sending and receiving by the corporate project person and processing by Enriched Email enables their classification and automatic uploading to the Corporate Documentation Cloud.

Predefined combinations of corporate project activities/significant events and corresponding project related documents are used during Enriched Email correspondence to generate a project realization correspondence chain and to track and monitor the implementation of a Corporate Project.

More information on corporate project activities/significant events and corresponding documents for all classes/types of Corporate Projects can be found here.

Corporate Documents Identification and Classification

For identification and classification of documents stored in the Corporate Documentation Cloud, a parallel system consisting of parallel identification and classification is used.

For identification, technically speaking in terms of relational database terminology, all documents are treated as a strong entity, identified by a single key, an ID number.

Such identification allows each document, with its unique ID number to be classified in relation to multiple classifications related to several business areas.

The classifications presented here were developed in terms of legislative and professional practice in the regulation of Pre-Clinical Tests, Clinical Trials, and Medicinal Products and can be easily adapted to suit specific corporate requirements.

Two separate classifications have been developed, one for Corporate Entities and the other for Corporate Projects.

Corporate entity definition documents - classification

Corporate entity definition documents are defined and classified with respect to the corporate entity characteristics defined for each class of Corporate Entities.

The classification is presented in the  Corporate Entity Document Classification which is the main classification of corporate entity definition documents.

Any other custom corporate classification system can be used in parallel, if such a requirement is present.

Corporate project documents - classification

Corporate project documents are classified with respect to corporate project activities/significant events combinations defined for each class/type of Corporate Projects. Project related documents are defined for each activity/significant event, of a Corporate Project using relevant business rules.

The classification can be seen for each class/type of Corporate Projects in the Standardized Corporate Projects section here.