Answer depends on how your documents are being managed currently, what manual processes being followed, what tools you are using, and how up-to-date are your plans/checklists.
Building, Publishing, Lifecycle Mgmt, Document Traceability. Easy?
Solutions & Sample
projects
- Generate multiple country specific dossiers from 1 master with 1 Click (avoid hours of manual drag/drop or copy/paste).
- ROW countries and other countries (for those that your current submission tools don’t support and those you’re doing manually), manage here full cycle - plan to build to review/validate to publish.
- Automate Dossier QC (Post-publishing) activities.
- Automate steps (with built-in BPM and Rules engine) you are doing manually in submission process and areas that your RIM or Publishing tools fall short.
- Manage full-cycle submission management from Document 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 (checklists & TOCs) built-in.
- Leverage built-in regulatory eDMS at no additional cost.
- Built-in regulatory project management to track your Tech File activities. This enables macro and micro views of projects so you don’t miss critical deadlines.
- Built-in 80+ 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 regulatory eDMS at no additional cost. The software can also be integrated with quality management or other systems to facilitate collaboration.
- Clone/copy and generate multiple copies from 1 tech file.
- Built-in regulatory project management to track your Tech File activities. This enables macro and micro views of projects so you don’t miss critical deadlines.
Benefits
- Automation: Most of your current annual process a document-level or pre-publishing are minimized drastically with built-in automation. In addition, Automate Dossier QC (Post-publishing) activities.
- Standardized Submission/Publishing Process: Best-practice templates will standardize your submissions and equip your organization with constant readiness and a head start for every registration. Active Standardization across different product applications.
- Increased Efficiency: Robust project management of routing, review, and approval of documents will greatly streamline your workflow and increase your efficiency. Tasks will no longer miss with automatic task notifications and timeline alerts.
- Increased Project Visibility: Tools such as dashboards and analytics will make your project visible to all users. During audits, there is nothing like the confidence of knowing that auditors will be able to find everything they need in one place.
- Connectivity: Submission projects scattered across jurisdictions require close collaboration among multiple teams. Our tool provide the connectivity to facilitate collaboration among yours take holders, including consultants and vendors.
- ROI: Guaranteed 30% and more productivity improvements utilizing this compared to your current processes.
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