Introduction to Regulatory Solution

The NextDocs Regulatory Document Management Solutions helps a user to manage the submission document lifecycle across departments in one place using innovative authoring and intelligent taxonomy features. The NextDocs submission management feature provides template based authoring capabilities with full metadata integration, thereby simplifying the electronic submission management process.

The solution employs a document lifecycle with a dedicated lifecycle management engine and sophisticated visual workflow functionality to ensure on-time authoring, review and approval of crucial submission documents. This ensures that you can manage all submission documents with full 21 CFR part 11 compliance and take advantage of electronic and digital signature capabilities to meet international regulatory requirements and standards.

The system provides the ability to tag crucial regulatory documents for all modules with eCTD metadata at the time when a document is created. It facilitates the collaboration of all departments in one global repository utilizing a common language based on standard taxonomy and pre-defined templates. It ensures perfect quality and consistency of all regulatory documents.