Solution: enaio® for regulatory affairs
The approval of drugs and medical products involves handling a large amount of documents. In recent years, manual document generation has largely given way to electronic processes. It is becoming increasingly common to submit information to authorities in PDF format.
The introduction of standards (eCTD, Nees, STED) has made documents smaller, but this has led to a considerable increase in the number of documents used. As a result, the administration of documents has become much more complex. File systems on file servers are no longer adequate as they do not meet the requirements of the authorities and standards.
There are many tasks that must be carried out to achieve modern and compliant document lifecycle management, including deadline management of all regulatory activities, the release and revision of approval documents, dossier management, the administration of associated documents, and the maintenance of a dossier record. enaio® provides the right tools for all of these tasks.
Benefit from central access to your documents – anytime, from any location.
Maintain a comprehensive overview of your regulatory activities.
Ready-made templates support the creation of consistent documents.
Efficiently manage all drug approval documents with our best-practice solution for regulatory affairs. Every document and file needed in connection with regulatory requirements and submissions can be managed in a transparent manner with our solution.
It supports existing filing structures as well as new, supplementary ones, while structure templates allow you to create dossiers (eCTD, Nees, STED) with ease.
OPTIMAL SYSTEMS is a
Group company of
Kyocera Document Solutions.
