Answer depends on what tools you are using, how they are connected and how much manual work you are doing currently.
Build, Version management, Doc Traceability. Easy?
Solutions & Sample
projects
- Generate multiple dossiers from 1 master with a Click (avoid hours of manual copy/paste or build)
- ROW countries and other countries (for those that your current submission tools don’t support and those you’re doing manually), manage here from plan to build to review/validate to publish
- Automate steps you are doing manually in submission process and areas that your RIM or Publishing tools fall short
- Automate QC
- Manage full-cycle submission management from Documents level publishing (automatically done) to Dossier-level submission publishing
- If you use external vendor or tool or eCTD, import those for better Document traceability
- All country plans built-in
- Built-in Country specific plans, requirements and templates. Build 510k, EU MDR and different country Tech Files and lifecycle applications with Ease
- Customizable plans/templates based on your requirements for Countries with custom requirements
- Publishing automated both at document and tech file level to save several hours of manual and tedious work
- Leverage built-in EDMS for better collaboration and Traceability
- Clone and generate multiple copies from master
Benefits
- Access all submission content from multiple sources within 1 interface
- Incorporate your internal file naming and other standards easily along with your metadata options to maintain compliance easily and eliminate QC/Reviews/Oversight
- Sophisticated rules engine
- Collaborative reviews with optional workflows, alerts and embedded project management
- Minimize errors, increase speed, reduce manual work with built-in automation
- Utilize built-in Global country requirements DB to be sure always
Future of the industry depends on the ability to bring the highest quality products to market quickly and cost-effectively. It takes speed and power to transform the life science product lifecycle. With our Technology and Automation solutions, organizations can digitize their processes faster and manage complex regulatory processes, without limitations.
Ready to digitize &Automate Submission Management?
The First Step
Let's talk about how DDi can help you