Electronic record and document content management system with electronic submission to regulatory agencies (eCTD).
Since 1990, ICH (International Conference on Harmonization) has been working to create a standardized framework for drug and biological product registration. An expert working group within ICH is working on the eCTD (electronic control technical document) specification, an electronic equivalent to paper CTD. An eCTD is primarily a specification for interfacing between the regulatory agency and the industry to enable the transfer of regulatory information while at the same time facilitating the initiation, creation, review, lifecycle management, and archival of the electronic submission.
eCDT Solution from SoluSoft
The eCDT Solution from SoluSoft
solution helps Pharmaceuticals
companies to create, update, store,
and publish the complete set of
dossier documents and manage,
compile, review, register and
archive eCTD submissions to
regulatory agencies like US FDA and
UK MHRA.
Business Objectives
The business objectives are as
follows:
Provide streamlined eCTD process
system that deals with complete life
cycle of eCTD submission from
initiation through reviewing,
verification, recording, approving,
and completion
Provide eCTD process
implementation per ICH eCTD
compliance
Provide eCTD submission output
format that is expected by
regulatory agencies
Utilize a single tool instead of
multiple disparate tools to process eCTD using task assignment,
deadline, alerts, escalation,
scheduling, collaboration,
discussion, routing, and version
control
Provide an audit trail to record
activity at every step
Provide validation and process
reports
Business Value
The business values are as follows:
Eliminate or minimize regulatory
risks and process delays
Increase in credibility due to
regulatory compliance
Structured and unstructured
information is organized and managed
