Products

eP2AS VAL

Check and correction system for submission-ready leaf files in eCTD publishing

Check and Correction System for submission-ready Leaf Files in eCTD Publishing
eP2AS VAL is a system designed to efficiently perform the task of converting leaf files into Submission-Ready (SR) format, specifically for regulatory approval applications. eP2AS VAL automatically checks and lists potential modifications based on evaluation rules specific to each regulatory authority (PMDA, FDA, EMA) for PDF and page requirements, document bookmarks, internal document links, file consistency, font color, image resolution, and other criteria in the electronic submission leaf files. The system works with PDF files converted from Word documents using rendering systems like DocShifter. By referring to the judgment results and messages in this list, users can make necessary corrections without overlooking any issues and complete the submission-ready leaf files.
Additionally, eP2AS VAL can be integrated with document management systems (DMS) and rendering systems to enable continuous automated processing of the entire workflow.
By automating tasks such as setting and verifying bookmarks and links, eP2AS VAL eliminates the traditional manual effort and time required, contributing to improved quality of eCTD submissions (reducing errors), cost reduction in document creation, time savings in the process, and overall improvement of eCTD publishing tasks for regulatory affairs personnel.