Corporate Documents

Corporate Entity Documents
- Entity related documents
- Entity definition documents
Corporate Project Documents
- Initial submission documents
- Related submission documents
- Project related documents
Corporate Documents - statuses

There are two classes of Corporate Documents:

Corporate entity documents - related to Corporate Entities and their creation/development activities
Corporate project documents - related to Corporate Projects and their activity/significant event combinations

Each Corporate Document is classified and related to either Corporate Entity or Corporate Project.

Corporate Documents can originate from the Pharmaceutical Corporation itself or from the Health Authorities or other Business Partners, therefore, in terms of their origin, they can be:

external documents
created and received from the third parties as attachments to regular emails, subjected to
Enriched Email processing and automatically uploaded to the Corporate Documentation Cloud
internal documents
created within the corporation and
- directly manually uploaded to the Corporate Documentation Cloud by the creator,
  or
- sent by the creator as an attachment to a enriched email message, when automatically uploaded to the Corporate Documentation Cloud
  or
- sent by the creator as an attachment to a regular email message, subjected to enrichment email processing by the recipient when automatically uploaded to the Corporate Documentation Cloud

An external document becomes a Corporate Document as soon as received as an attachment and processed by Enriched Email.

An internal document must go through several statuses before it becomes a Corporate Document , from a draft, an approved draft (optional) to a document. Once it becomes a Corporate Document, it can be subjected to numerous editorial and substantial changes.

Also, certain Corporate Documents can be a part of several types of project initial submissions and they are classified with respect to that.

It is important to note that all Corporate Documents, regardless of their origin, relationship to Corporate Entities or Corporate Projects, and their status are uploaded and stored on the Corporate Documentation Cloud. They are either uploaded manually using the application form or automatically when sent or received by Enriched Email.

All Corporate Documents can be easily searched, accessed and downloaded either:

separately, searching by using their classification, status and relations to Corporate Entities or Corporate Projects
or
as a collection of documents, i.e. a project initial submission, using various legislative or corporate templates as the selection tool

Corporate Entity Documents

Corporate entity documents are Corporate Documents created by corporate entity persons during the creation, subsequent development, and substantial changes of Corporate Entities or received by corporate entity persons as attachments to incoming enriched/regular email messages sent to them by other corporate persons or by Business Partners.

Corporate entity documents are classified in the following categories:

entity related documents - documents generated during the development of a new Corporate Entity or the subsequent development of an existing one
- basis for creation documents - predefined documents that relate to and narratively define the basis for creation of Corporate Entities
- basis for change documents - predefined documents that relate to and narratively define basis for change of Corporate Entities
- structural entity documents - predefined documents generated from the eCTD Integral Information System Database using structural data of Corporate Entities
- project entity documents - predefined documents describing the final results of a Corporate Project
- related documents - general non-predefined documents generated during the development of a new Corporate Entity or the subsequent development of an existing one
entity definition documents - predefined documents that relate and narratively define new Corporate Entities or changes to existing Corporate Entities

It is important to note that by selecting a Corporate Entity as a topic in the Enriched Email correspondence complete life cycle, from the creation through all subsequent development and changes can be displayed. By using the Enriched Email Correspondence and the entities creation/development correspondence chain, it is possible to monitor the generation and changes of corporate entity documents in real-time.

The corporate entity documents classified with respect to Corporate Entities and document classes are presented here.

A detailed description of Corporate Entities' creation processes with the generation of entity definition documents defining new Corporate Entities is given here.

Detailed description of Corporate Entities' development and change processes with the generation of entity definition documents defining substantial changes to Corporate Entities is given here.

Entity related documents

Basis for creation documents

Each basis for creation document is attached to a enriched email message which itself initiates the entities creation correspondence chain. Processing of such an enriched email message on the application form for new Corporate Entity creation automatically generates a core sequence in the eCTD Integral Information System and the corresponding directory tree with replacement entity definition documents necessary to narratively define the new Corporate Entity.

Basis for change documents

Each basis for change document is attached to a enriched email message which is a part of the entity development/change correspondence chain. Processing such a enriched email message either automatically generates a new company core sequence or automatically links to an existing core sequence in the eCTD Integral Information System which represents a change of the related Corporate Entity.

Structural entity documents

Structural entity documents are generated directly from the eCTD Integral Information System using structural data of Corporate Entities.

Among other things, the structural definition of Corporate Entities serves the purpose to structurally define entities to that extent to enable generation of various XML structural documents, eCTD Marketing Authorization Application Forms and manufacturing process flow-chart being the good examples, directly from the eCTD Integral Information System.

Structural entity documents can also enable direct communication between databases of Pharmaceutical Corporation and Health Authorities and various Health Institutions if the other sides are capable of such a thing.

Project entity documents

Project entity documents are related to both: Corporate Entity and Corporate Project.

The project entity documents are marked with "F" in the directory tree with replacement entity definition documents.

During the last project activity, a set of final project entity documents is generated or received to define the Corporate Project results and results interpretation. These documents also refer to Corporate Entities and their definition and are later used in initial submissions for the realization of Corporate Projects. Typical examples are:

pre-clinical tests reports
clinical trial reports
marketing authorizations
spc, pil and labeling documents and their translations

Entity definition documents

Narrative entity definition documents are made by designated corporate entity persons. Uploading entity definition documents to the Corporate Documentation Cloud is done by using the application form "New Corporate entity/<Entity>/Narrative Data" and following the appropriate directory tree with replacement entity definition documents.

Among other things, the narrative definition documents of Corporate Entities serve the purpose to narratively define entities to that extent to enable automatic generation of various project initial submissions directly from the eCTD Integral Information System. Using the modular nature of eCTD Integral Information System and eCTD or corporate templates, previously created entity definition documents are downloaded to the local workstation to be submitted at the beginning of the Corporate Project realization.

Editorial changes of entity definition documents are used for the generation of project related submissions.

Since all entity definition documents are part of one or more project initial submissions, for each document directory paths are defined for each type of project initial submission.

Corporate Project Documents

Corporate project documents are Corporate Documents created, during the realization of Corporate Projects and their activities. They are either created by corporate project persons and sent as attachments to enriched email messages or received by corporate project persons as attachments to incoming enriched/regular email messages sent by other corporate persons or Health Authorities and Business Partners.

Corporate project documents are classified in the following categories:

project initial submission documents - documents generated during the preparation of initial submission to the Health Authorities, Health Institutions and Business Partners at the very beginning of the realization of Corporate Project.
project related submission documents - documents generated during the preparation of related submission to Health Authorities, Health Institutions and Business Partners
project related documents
- project implementation documents - predefined documents generated during the implementation of Corporate Projects
- project entity documents - predefined documents generated at the end of Regulatory Projects describing project results
- related documents - general non-predefined documents generated during the implementation of a Corporate Project

A detailed description of the realization of different types of Corporate Projects and the generation of corporate project documents is given here.

Initial submission documents

The project initial submissions are created at the very beginning of the Corporate Projects, during the "initial submission preparation" activity. They represent the documentary basis for project realization and their completeness is the main prerequisite for the beginning of the Corporate Project implementation.

It is important to note that eCTD submission approach is extended to include documents required to make project initial submissions for Pre-Clinical Tests, Clinical Trials, and Marketing Campaigns. All required standardized project initial submissions for those types of Corporate Projects are defined. Also, in order to complete the extension of eCTD approach, Variations for Clinical Trials together with related basis for change documents are defined.

Variations for Clinical Trials with the "basis for change" documents are presented here.

Each project initial submission consists of:

entity definition documents - documents that are created in advance, before the project initiation and can be used in many initial submissions of various types of Corporate Projects
project submission documents - documents that cannot be created in advance, can be created only during the project "launch preparation activity" and can be used only once for the realization of that specific Corporate Project
project entity documents of the previously finished related Corporate Projects

For documents that are part of one or more project initial submissions types, a directory path is defined for each type of submission directory tree using legislative eCTD or corporate templates. All submission directory trees are stored in the eCTD Integral Information System Database.

It is important to note that once all entity definition documents are created and uploaded by the entity person(s) and all project submission documents are created and uploaded by the local caproate project person, the entire project initial submission can be automatically downloaded to the local workstation at the appropriate directory tree location.

Project related documents

During the implementation of a Corporate Project following types of project related documents are generated:

project implementation documents - predefined documents generated during the implementation of Corporate Projects
project entity documents - predefined documents generated at the end of Corporate Projects describing project results

Project implementation documents

The project implementation documents are generated during the implementation of Corporate Projects. With respect to their origin they can be external and internal.

All important and frequently generated project implementation documents, internal and external, should be standardized by defining their templates.

Templates increase the efficiency of document creation, eliminate incomplete reporting and make the use of email attachments mandatory, preventing the use of the "text box" of email messages instead of predefined documents.

For each type of Corporate Project, a class of related documents is defined, which is used for all non-standardized documents.

It is important to note that by using the Enriched Email Correspondence and the project realization correspondence chain, it is possible to monitor the generation of project implementation documents in real-time.

Project entity documents

Project entity documents are related to both: Corporate Entity and Corporate Project.

The project entity documents are marked with "F" in the directory tree with replacement entity definition documents. During the last project activity, a set of final predefined project entity documents is generated or received to define the Corporate Project results and results interpretation. For all project entity documents templates should be defined.

A typical example is a clinical trial report, generated at the end of the realization of a Clinical Trial and later used in project initial submissions for a Marketing Authorization Application type of Corporate Projects.

It is important to note that project entity documents, created at the end of the realization of the Corporate Project, are later used to generate project initial submissions for other type of projects.

*Corporate Documents - statuses***

With respect to their approval status Corporate Documents can be:

Corporate Documents - with approval - a draft document must be approved by the senior manager of the person who created it to become a corporate document
Corporate Documents - without approval - a draft document does not have to be approved to become a corporate document

Documents created within the corporation and manually uploaded to the Corporate Documentation Cloud become Corporate Documents when for the first time sent via Enriched Email to other corporate and/or third-party correspondents, or, when for the first time downloaded as a part of a project initial submission and submitted to Health Authorities or/and third party Business Partners.

External document(s) received from the third party correspondent as an attachment(s) to regular email become Corporate Document(s) when regular email is registered, linked with corresponding Corporate Entity or Corporate Project, and attachment(s) classified and automatically uploaded to the Corporate Documentation Cloud.

Documents that are not part of any project initial submission, can not become Corporate Documents without being subjected to Enriched Email processing.

During their life cycle, the Corporate Documents pass through various statuses depending on their origin and approval type:

Company created Corporate Documents, created within the corporation by company employees
- Company created Corporate Documents - mandatory approval
  - “draft”
    A draft uploaded on the Corporate Documentation Cloud by the person who created it. A draft can be edited many times before it is pronounced ready for approval by a senior person/manager
  - “draft pending approval”
    A draft uploaded on the Corporate Documentation Cloud and pronounced ready for approval by a senior person/manager. The outcome can be an approved draft or a draft with comments. The draft with comments, which is amended based on the comments of a senior person / manager, becomes a draft pending approval again
  - “approved draft”
    The approved draft can be sent via Enriched Email or downloaded as a part of project initial submission to become document. If necessary the approved draft can be edited with the change of its status back to the "draft pending approval"
  - “document”
    Approved draft sent for business purposes, externally or internally via Enriched Email, to a legal entity(s) and/or individual(s). After that, the document can not be changed without notifying all legal entities or persons who are in the possession of it
- Company created Corporate Documents - without approval
  - "draft"
    A draft uploaded on the Corporate Documentation Cloud by the person who created it. Draft can be edited many times before it becomes document by being sent via Registered Email to to legal entity(s) and/or individual(s)
  - "document"
    Sent for business purposes, externally or internally via Enriched Email, to legal entity(s) and/or individual(s). The document cannot be changed without notifying all legal entities or persons who are in possession of it
Externally created Corporate Documents, created by third parties
- "document"
  Received and registered via Enriched Email and automatically uploaded to the Corporate Documentation Cloud. Document can not be changed within the corporation. If related to a Corporate Entity, it can only be classified as one of the "basis for change" documents or a related document.
Mutual Corporate Documents, created within the Corporation and by third party(s)
Various contracts, agreements, and their amendments between the Corporation and third party(s)
- Mutual Corporate Documents - received from third party
  - "draft pending approval"
- Mutual Corporate Documents - sent as a reply to third party(s)
  - "document"
- Mutual Corporate Documents - sent to third party(s)
  - "draft pending approval"
- Mutual Corporate Documents - received as a reply from third party
  - "document"

All internal and external Corporate Documents can be easily searched, accessed and downloaded either:

separately, searching by using their relations to Corporate Entities or Corporate Projects
or
as a collection of documents using various legislative and corporate templates as a selection tool

Corporate Documents

Corporate Entity Documents

Corporate Project Documents