eCTD Dossier Life cycle and Query Management
Sarjen with its industry focused KnowledgeNET, helps clients accelerate innovation and increase their ROI considerably in R&D. KnowledgeNET provides quick and intuitive construction of complex electronic submission for any regulatory authority. It provides a simple and a easy-to-use user interface with multiple regional support that includes Canada, EU and US with multiple parallel users.
Sarjen, one of the very few software vendors vantaged with intellectual and effective strategic corporate level consulting, has considerable number of successful submissions of eCTDs and eDMFs to its credit. KnowledgeNET, one of a kind off-the-shelf-solution, when integrated with business can produce outstanding results. Geared up with an integrated validator, provides accuracy, efficiency and robustness to the cumbersome submission process.
Sarjen, with its dedicated employees and quality in their mindset, understands the principles of effective business to the fullest and provides strategic corporate level consulting to its clients.
KnowledgeNET in itself is a complete package that provides creating, organizing, sharing, archiving and managing complete dossiers with minimum efforts. KnowledgeNET keeps you just a click away from achieving regulatory compliance and cross all boundaries in the cumbersome submission process. KnowledgeNET serves multiple users connected parallely in a user-friendly environment providing an interface between the industry and agency for transfer of regulatory information while at the same time taking into consideration the facilitation of creation, review, above all, the life cycle management and archiving of the electronic submission, and also maintaining an audit trail as per the 21 CFR Part 11 compliance.
Special Features
- User-friendly intuitive, Web based interface
- Online training guides
- Dashboard for usage directions
- Standard regional specific pre-configured structures/templates are inbuilt within the solution (i.e., US FDA, EMEA, etc.)
- Build the XML backbone and other eCTD components with transparent user interface
- Creation of separate internal and external submission sequence no. to manage revised submission/s
- Facility of HTML Publishing the dossier in CTD format for non regulated Market (i.e., countries in South America, Africa, etc.)
- Follows standards of ICH for eCTD
- Generate MD5 check sum
- Full Audit trail and access controls as per 21 CFR Part 11 guidelines
- Shorter implementation cycle
- Dossier conversion service also available
- Effective use of infrastructure resources to reduce TCO (total cost of ownership)
