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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.
Template	Poor userability; Do not support a greater version of Office Word®.
Quality Check Level	Check visually; Do not have suitable tools.
Model Documents	Do not keep updated with Word® template.
Manuals/Training	See Common Issues.
Authors	Have different levels of documentation skills.