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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eCTD and Document Management Cloud Solutions
Oct24

eCTD and Document Management Cloud Solutions

With increasing options for cloud-based eCTD and electronic document management systems (EDMS), small and large pharma companies are faced with evaluating the benefits and risks of implementing these systems in the cloud compared to traditional onsite or hosted deployment models. Cloud eDMS Benefits One benefit is streamlining the implementation effort. A cloud-based EDMS should be up and running within weeks compared to an onsite...

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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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