Managing Regulated Content Items Stored on Non-Regulated Storage Platforms

Abstract

Methods and systems of storing and managing regulated content items on a non-regulated storage platform are provided. A request to create a regulated content item of which content is subject to one or more regulations is received. The regulated content item is created. An integrity record associated with the regulated content item based on the content of the regulated content item is created. The regulated content item is provided to the non-regulated storage platform for storage. An integrity of the regulated content item stored on the non-regulated storage platform is verified based at least in part on the integrity record.

Description

CROSS REFERENCE TO RELATED APPLICATION(S)[0001]This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application Ser. No. 62 / 201,498, “Content Integrity Verification for Regulated Content Stored on a Non-regulated Content Platform,” filed Aug. 5, 2015 and U.S. Provisional Patent Application Ser. No. 62 / 276,224, “Systems and Methods for Sharing Content Between Non-regulated and Regulated Platforms,” filed Jan. 7, 2016. The subject matter of each of the foregoing is incorporated herein by reference in its respective entirety.BACKGROUND[0002]Field of Disclosure[0003]This application relates generally to managing regulated content (e.g., FDA regulated content) on non-regulated storage platforms. In particular, the application relates to maintaining integrity of regulated content stored on non-regulated storage platforms.[0004]Description of the Related Art[0005]Today, regulated content such as FDA regulated documents and files, are heavily regulated, includ...

AI Technical Summary

Benefits of technology

The patent describes a computer-implemented method and system for storing and managing regulated content items on a non-regulated storage platform. The technical effect of this invention is to enable secure and organized storage of regulated content items, with a means for verifying their integrity and access restrictions. This system can be adapted for different types of regulations and can provide a safe mechanism for storing and managing sensitive information.

Problems solved by technology

This limits the ability of organizations to store their regulated content, and often requires expensive subscriptions by these organizations to regulated storage services that have gone through the procedures to meet and maintain their ability to store regulated content.

These regulated storage platforms are more limited in storage capacity and capability, and are commonly a high expense for organizations for regulated content.

Typically, cloud content management services or public cloud storage platforms are not validated to meet various requirements such as data integrity, data control, change and release management, and user acceptance testing requirements imposed by FDA regulations.

Accordingly, while these non-regulated storage platforms are easy to use, often free, and provide a large amount of storage capacity, these storage platforms cannot be used for managing regulated documents and files.

Another inconvenience for companies with regulated content is that these companies often have to use multiple storage platforms for managing regulated and non-regulated content to meet their business needs and to comply with regulations.

This is because specialized regulated document management systems are not designed for managing non-regulated business content and are typically not economically viable for managing both types of content.

Managing multiple storage platforms can increase operational costs and reduce operational efficiency.

Using multiple storage platforms to manage regulated and non-regulated content can impede company-wide collaboration and may also prevent the companies from viewing content from a holistic perspective as distinct from a functional or process perspective.

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