How Unwritten Agency Rules Affect eCTD System Migration
Feb25

How Unwritten Agency Rules Affect eCTD System Migration

The true challenge of eCTD migration is your impact analysis (i.e. downtime, architectural changes and environmental changes) and determining whether or not your selected vendor supports unwritten Agency rules. Bear in mind that subtle differences exist among vendors who have implemented eCTD systems. You need to ensure that your chosen vendor has experience migrating submissions, not only from your existing system, but from all systems that generated eCTD that you now have to manage.

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Five Points to Consider When Selecting an Enterprise eCTD Viewer
Oct16

Five Points to Consider When Selecting an Enterprise eCTD Viewer

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.

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Implementing a Cloud-based eCTD Solution
Apr25

Implementing a Cloud-based eCTD Solution

Cloud technology considerations should not be restricted to your organization’s IT professionals any longer. Business owners must take an active role in understanding the technology and its potential impact. Deliberations on adoption of an in-house system deployment versus cloud-managed systems center on initial implementation and ongoing maintenance. Additional points to weigh include resource support and the value of your...

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eCTD Cloud Vendor Selection Q&A

GlobalSubmit recently held an educational webinar entitled Regulatory and the Cloud Vendor Selection. Software as a service (SaaS, typically pronounced [sæs]), often referred to as “cloud technology” or “on-demand software,” is a software delivery model in which software and its associated data are hosted centrally, typically in the Internet. The combination of ever-more-abundant bandwidth, increasingly powerful...

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Achieving Efficiency and Compliance in Electronic Submissions

We’ve had several good eCTD-related conferences lately. I’ll be providing some updates on them in my next blog entry, but first I wanted to mention an upcoming conference that sounds really good. This is the Cambridge Healthtech Institute conference: eCTD 2010: Achieving Efficiency and Compliance in Electronic Submissions. This conference will be held March 10, 2010 at the Crowne Plaza Philadelphia Downtown in Philadelphia (which is...

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