eCTD Editor® - features

For increased productivity of your regulatory submission team

Content

Features

  • There is no need to know the eCTD format specification.
  • The software is always up to date. There is no need to monitor changes in eCTD format specifications.
  • The software is very simple. One hour of training is sufficient.
  • With this software you will be productive. You can create one variation application sequence, e.g. changes in a SmPC and PIL, in a minute.
  • Web based application. ­ Multiple users can work with the software at the same time.
  • Automatic conversion to pdf version form MS Word file format.
  • Automatic conversion of pdf files into the required version. Older versions of PDFs are often generated for example by scanning. Automatic conversion to fast web view pdf files.
  • ­Document upload by “Drag and Drop”.
  • Automatic document lifecycle management. The application monitors which previous document can be replaced, attached, deleted, etc.
  • Automatically adding correct document names in situations where a single name is prescribed.
  • "User friendly". The application recommends the correct name of inserted document according format specifications. There is no need to read these long and technical documents.
  • ­Automatically copy envelope data (M1 EU) and Admin Parts (M1 - US) from the previous sequence.
  • ­Automatic conversion of html links within the sequence to relative in the case of MS Word documents.
  • The software works in an Internet browser environment. There's nothing to install.
  • Automatic generation of valid sequences.

Main View

eCTD Editor - hlavní obrazovka

The main screen shows:

List of medicinal products

The table contains all medicinal products or just those that have the last sequence not sent, which can be determined by a folder selection. The items in the table can be sorted, filtered, divided into groups, etc.

Panel with documentation folder

The software generates the basic folder tree.

Where possible, the user can create new folders. If the obligation exists to insert some the software forces you to insert them.

New folder creation

In a situation where the specification allows creating a new folder, the following icon is available:

The application publishes the labels for the individual allowed folder names. The following is a folder creation in the 10-cover folder:

eCTD Editor - folder creation

Attributes specification of the folder if the folder requires it. The example is a subfolder in the 32s-drug-sub folder: substance and manufacturer:

Choose a language in part 131-spclabelpl and national subfolders:

eCTD Editor

Panel with a content of the selected folder

eCTD Editor - content of the selected folder

The table shows:

  • File Name,
  • Title,
  • Attributes (if any)
  • Xml element,
  • Operation Type: new, append, delete, replace,
  • Link to referenced file (in case of delete, replace or append)
  • Html link to the source file - The file opens in the appropriate editor and is available immediately. Saving is done through the WebDAV protocol directly to the server. There is no need to download, update, and then return it back to the editor.

Current versions panel

eCTD Editor - Current versions panel

This panel displays an overview of valid documents in the current folder. It displays only those documents that have not been deleted or replaced in later sequences.

Properties panel

The panel displays the properties of the selected folder or file. The form varies depending on the type of selected folder or file. It may look like this:

eCTD Properties panel

Documents upload

When upload of document is possible this icon appears:

eCTD Editor - ikona vložení souboru

The dialog for inserting a file differs depending on the part of the hierarchy where the document is inserted, whether it is the first sequence or not etc.

The dialog can look like this:

eCTD Editor - file upload

It is possible to drag a file from the Windows Explorer (dragging the file to blue rectangle “Drag file here to upload”).

The offer of types of insertable documents is commented. These are texts from format specifications. The original long ectd specification does not need to be studied:

eCTD Editor - content type selection

If the specification requires the insertion of attributes, the application makes you to do so:

eCTD Editor - attribute fields

When documents are added to following sequences it is possible to choose other operations than new, e.g. replace, append or delete.

In this case, the dialog offers according to the type of element to be inserted (Element type box) in the Modified File box the documents from the previous sequences that can be used:

eCTD Editor - selection of source document in append operation

The browser to select the previous document contains a link. The document can be opened for review.

Envelope (EU) or Administrative Part (USA) creation

M1-EU

If the users selects the EU folder, properties panel contains the Envelope form.

eCTD Editor - EU envelope creation

All dropdowns have their values with comments from the relevant specifications. So do the fields. See this picture:

eCTD Editor - EU envelope fields commented

M1-US

M1-US works similarly to M1-EU. The application contains the text guides for each column based on eCTD format specification.

Validation

Validation is started with this icon:

eCTD Editor - spuštění validace

Validation results:

eCTD Editor - validation

It is possible to use any other eCTD validator.

The errors can be filtered using “Show Errors Only”.

Export

Formát eCTD

eCTD sequence export is started with following icon:

eCTD Editor - export do eCTD formátu

During the export, the program performs the following:

  • Converts MS Word files to pdf.
  • Checks pdf files and converts them to a later version if they are in unsupported versions. (Typically from scanners, etc.)
  • Converts pdf to turn on fast web view.
  • Calculates checksums, removes unused folders.
  • Perform a number of other control tasks. The resulting export can be downloaded and sent to the regulatory authority.

NeeS Export

Export is started with following icon:

eCTD Editor - export do NeeS formátu

The NeeS format may be useful in situations when the Regulatory Authority requires transformation of Module 3 into eCTD.