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