Documentum Submission Store and View Solution
- Pharmaceutical and biotech companies
- Regulatory health agencies
- Deliver a complete view of regulatory activity
- Securely store submissions and correspondence in one place
- Streamline Electronic Common Technical Document (eCTD) viewing
Compliant, Secure Storage
Quick, Easy Search
eCTD View Streamlining
Life sciences organizations produce large volumes of documentation when submitting applications to regulatory agencies. This documentation includes not only the application itself but all related communications and records of interactions between the company and the regulatory authority.
Today most organizations use publishing tools to submit their regulatory submissions; these tools then store the submissions on file shares. Simultaneously, numerous agency queries and response documents, meeting materials, and telephone conversation records are saved in emails, shared drives, laptops, or collaboration tools. Responding to inquiries and keeping track of communications between the sponsor and the agency can quickly spiral into a complex, unorganized mess. Hours get wasted searching multiple systems, duplicating efforts, and making repeated calls to regulatory affiliates asking for the latest information or status.
The EMC Documentum Submission Store and View solution, part of the EMC Documentum for Life Sciences solution suite, simplifies the search and retrieval of archived submissions and their associated correspondence while improving security and compliance. The solution links regulatory correspondence and communications to submission files, enabling a full view of regulatory activity.
Our solution also automatically stores electronic common technical documents (eCTDs), noneCTD electronic submissions (NeeS), and paper submissions into a scalable EMC Documentum repository that delivers advanced security, audit trail, metadata, and indexing capabilities.
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- Operationalizing Excellence in the Global Regulatory Submissions Process
- Pervasive Governance: Rethinking Traditional Approaches to Information Governance
- EMC Consulting Regulated Information Management for Life Sciences
- EMC Consulting Regulatory Submissions Planning and Tracking
- EMC Documentum Submission Store and View
- EMC Documentum Electronic Trial Master File
- EMC Documentum Quality and Manufacturing
- EMC Documentum Research and Development