株式会社eMaterials

Language:  日本語 | English

Documentation Support Template «Authoring Pro»
eCTD Requirements Based Quality Check Service «eQC Outsourcing»

Authoring Environment Consulting Service

Authoring Environment Consulting Service Overview

Authoring Environment Consulting Service ("AECS", as following) is a service that provides advice on electronic documentation based on eCTD requirements of pharmaceutical industry. AECS aims to help clients to address their weak points and improve processes of the authoring environment.

What is Authoring Environment?

Authoring environment for pharmaceutical industry is a comprehensive environment for creating electronic documents, and usually includes points as below.

  • System Environment (Software & Version, etc.)
  • Regulations (Style Guide, etc.)
  • Word® Template
  • Quality Check Level
  • Model Documents
  • Manuals
  • Training
  • Authors

Issues of Authoring Environment

Common Issues

  • Have authoring environment of no practical use or no environment at all
  • Have authoring environment once built but never updated for new needs
  • Specific Issue
    System Environment
    (Software & Version, etc.)
    Different versions of Office Word® are used.
    Regulations
    (Style Guide, etc.)
    Regulations do not address eCTD requirements.
    TemplatePoor userability; Do not support a greater version of Office Word®.
    Quality Check LevelCheck visually; Do not have suitable tools.
    Model DocumentsDo not keep updated with Word® template.
    Manuals/TrainingSee Common Issues.
    AuthorsHave different levels of documentation skills.

For detail information of our services, please feel free toRequestor directly call us (03-6427-9698 9:30~17:00/Weekday).