en-UScs-CZsk-SK

eCTD Editor® - features

For greater productivity of individuals and registration teams

Content

Productivity

The app will keep you productive. The editor simplifies or completely automates many activities:

  • Automatic file naming.
  • Inserting files using the drag & drop method. Bulk insertion of documents where a single content type is allowed in a folder.
  • Bulk deletion, i.e. creating tickets with Delete operation. Just select the documents that the editor offers as allowed for this operation.
  • Automatic folder closure. The editor scans the folder including all subfolders and generates records with a delete operation for all valid documents. Useful when closing a folder in, for example, 32p-drug-prod.
  • Automatic creation of user folders based on historical sequences (32p-drug-prod, 32s-drug-sub, 32a-app, 32a1-fac-equip, 32a2-advent-agent, ...) including attribute values.
  • Possibility to create a new copy sequence from an existing one, even from another product. Valid only for records with operation type new.
  • Automatic generation of administrative sequence data on the basis of previous sequence data or on the basis of country selection (M1-EU region).
  • Providing an overall view of the documentation with Viewer. Viewer offers two types of views, sequential and consolidated.
  • For each folder, the editor allows you to view not only the current content, but also the evolution of the content in history.
  • In the replace method for documents that require attributes, the values of these attributes are set automatically.
  • With append, replace, delete methods, the editor offers only documents from historical sequences that do not cause a validation error.
  • The editor allows you to work with documents in MS Office format. The editor converts them to pdf documents automatically during export.
  • Convenient work with updating texts in saved files. Even if you work with the server via the Internet, in Word the opened document is saved not in the local tmp folder but in the original location in the sequence on the editor server.
  • Automatic conversion of html links to other documents in the current or previous sequence to relative. This will make the links functional in the IT environment of the regulatory authority. Html links can be created directly in Word.
  • The editor allows you to generate consolidated documentation.
  • The editor records the activities of individual users. It is possible to trace who is responsible for which change.
  • Automatic editing of pdf documents to meet maximum even best practice validation criteria (e.g.: version upgrade, inherit zoom settings for html links, fast web view settings, initial zoom, bookmark panel display, ...)
  • You can open not only the current file but also the file from the previous sequence that is affected by replace, append, delete.

Easy to use

  • The application is simple. It takes about 2 hours to train.
  • "User friendly". The application publishes, wherever possible, instructional texts from the guidelines and eCTD specifications. There is no need to read these long and technical documents.
  • As a prospective user, you can be sure that you will master the application. We will provide you with unlimited consultations for the first month (or any other specified month).

Technical aspects

  • ECTD Editor je síťová aplikace. Je možné ji obsluhovat prostřednictvím prohlížeče Edge nebo prostřednictvím aplikace pro Windows.
  • Server může být dedikovaný počítač, ale může běžet i na jediném notebooku pro jednoho uživatele.
  • Aplikace je vždy aktuální. Není třeba sledovat vývoj specifikací formátu eCTD.

 

 

 

 

 

 

 

 

logo5

The author of the website is the company Human Ways. This company is engaged in the development of software eCTD Editor, software for the production of drugs Orgnes and software for the formalization of management according to GAMP - RelNet.

About us

Trademarks

eCTD Editor® is a combined trademark owned by Human Ways, s.r.o. registered by the Industrial Property Office of the Czech Republic under registration number 324409.