KnowledgeNet : eCTD Software to compile your eCTD dossiers effortlessly with immaculate precision taking into consideration all the norms as framed by the regulatory authorities.
Knowledgenet is a complete eCTD dossier publishing & submission solution and is fully compliant with ectd module 1 specifications EU v2.0, US FDA (v2.01 and v2.3), GCC v1.2 and v1.5, South Africa (ZA-MCC) v1.0, Canada v2.2, Swissmedic (CH) v1.3, Thailand (Thai-FDA) v1.0, AU v3.0 and similar regulatory authorities and NeeS specifications EU v2.0, GCC v1.2 and v1.5, AU/NZ v1.0
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 parallel 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.
KnowledgeNET in itself is a complete package that provides creating, organizing, sharing, archiving and managing complete dossiers with minimum efforts.
KnowledgeNET is a complete eCTD software for publishing and submission of dossier
|Region specific eCTD Dossier publishing & submission planning and life cycle management||PDF auto correct||Submissions & Publishing documents|
|Dossier compilation||Submit submissions||Post submission query management|
KnowledgeNET, eCTD software can easily save a company thousands of dollars by effectively utilising the eCTD software features.
Other eCTD related software by Sarjen: Query Management (QM)
QM is a unique feature which helps in tracking creation, review and updates of submissions, amendments, Regulatory Agency’s query response along with its compilation and review.
Thus, giving the company a quick response time to resolve warning letters or other issues.
By QM, real-time alerts and notifications could be sent to appropriate users for further correspondence.