eCTD and Document Management Cloud Solutions

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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 deployment that could take years. A cloud-based EDMS should have turnkey configuration for content libraries and document lifecycle workflows that can be implemented with little to no customization. A system with few customizations should be able to be implemented faster, cheaper, and ultimately perform better since the system design/configuration is well understood, tested, and consistently deployed by the vendor that supplies and supports the application.

Another benefit is improved performance for end users that are spread out geographically. In most cases, the only requirement for end users to operate the application is an Internet connection and reasonably good bandwidth. For cloud-based eCTD applications, this becomes an appealing way to manage workload peaks through temporarily providing access to remote publishers to process a bolus of documents to meet submission deadlines rather than relying on all publishers to work onsite or rely on VPN connections to access data and applications remotely.

Cloud eDMS Risks

Some of the risks include evaluating whether or not a cloud-based system can be adequately documented and validated. Fundamentally, the effort to document and validate the system should be held to the same rigor as a system that is deployed in house. Due to the nature of cloud computing, the details found in the system design, configuration, and associated governing procedures are going to be different than what is traditionally represented for an in-house system deployment. Additionally, it’s important that the vendor providing the software as a service (SaaS) system has properly vetted the infrastructure service provider to ensure anyone with access to a sponsor’s data is adequately trained to maintain the validated state of the system.

Another risk is ensuring proper security and confidentiality of your data. This activity entails reviewing that disaster recovery and back-up/restore procedures are in place and have been tested, ensuring that encryption measures are taken when data are moving and at rest, and ensuring that access controls to data are limited so that content cannot be inadvertently shared across organizations on the same platform.

Conclusion on Cloud eDMS Systems

Cloud computing is here to stay, and it’s clear that more options to manage regulated content in the cloud will be emerging over time. And while the cloud can be a compelling option for many life science companies, understanding of the risks associated with vendor selection is a critical first step.

Cloud eDMS White Paper

Jason Rock, CTO at GlobalSubmit and Russ King, President at MethodSense recently co-authored a white paper detailing the benefits and risks of the cloud vendor selection. Click here to request a copy of the white paper.

Author: Emily Onkka

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