When selecting a system for cross-department viewing of eCTD submissions, as well as archiving, here are some important points you’ll want to give proper attention.
As you might have guessed, an enterprise viewing system is meant for wide scale deployment across departments and at multiple locations. The more robust a system the better it is able to handle increased submission volume and the addition of nodes to a network.
An ongoing industry initiative involves regional affiliates participating in the management of regulatory information. A robust enterprise viewing system will give all relevant members of your organization visibility and create an authoritative, centralized repository of eCTD records.
2. Anytime, Anywhere Access
The rate of outsourcing for eCTD submission projects is increasing; a recently published white paper by Gens and Associates showed that the percentage of companies currently outsourcing jumped from 41% in 2007 to 80% in 2014. The percentage of companies who said they would explore expanded or new outsourcing programs also grew, this time from 26% in 2007 to 65% in 2014.
Before you even consider how difficult it is to work with disconnected, offline internal information, you need to consider the risks associated with being blind to the progress of mission-critical submissions in the care of an outsourcing vendor.
Implementing an enterprise viewing system available in the Cloud provides nearly real-time access to submission progress. Any employee who is responsible for viewing active projects or archived submissions only needs an internet connection and the proper credentials to sign into a multi-tenant deployment of eCTD software.
3. Permission-Based Roles
Submission documents contain extremely sensitive intellectual property. It’s paramount that this sensitive information is kept secure and is only shared with credentialed personnel. When implementing a system designed for company-wide use, you’ll want the administrator to have the tools at his/her disposal to customize access rights down to the document.
4. Ease of Migration
Consider a large pharmaceutical company with thousands of sequences stored in its archives – in paper volumes or digitally. If that company’s technology vendor stops supporting its eCTD software, you’ll need to transfer those files without risking corrupted or lost data. In such a scenario, you want to find a vendor with a verifiable track record of supporting global, Tier I pharmaceuticals that have performed such a migration. An affiliation with an Agency is another reassuring qualification. A vendor whose software technology is in use at an Agency would have already successfully loaded your submissions – provided that you’ve filed to that region.
5. Platform Consolidation
Life science companies would love to consolidate all of their regulatory solutions down to a single platform, supported by a single vendor. Whittling down your software providers to one solves many compatibility issues, makes upgrading much more manageable, streamlines customer support and makes for a much more intuitive, memorable user experience. An enterprise solution that allows for your core users in Regulatory Operations and Affairs to share the same review experience as CMC, Medical Affairs and Clinical Operations eases communication, provides optimal visibility and increases the trustworthiness of the data being entered and reported on.