GlobalSubmit Inc. gets its Document Management System & Business Process Management on AWS Cloud, built with Microsoft SharePoint and Nintex
Headquartered in Philadelphia, GlobalSubmit Inc. is dedicated to facilitating regulatory submissions between life sciences companies and global regulatory agencies. Since 2005, GlobalSubmit has been the U.S. Food & Drug Administration’s sole eCTD software vendor and The FDA relies exclusively on GlobalSubmit’s platforms to evaluate the technical validity of 100% of the electronic submissions it receives.
GlobalSubmit wanted a document management system in their environment which was setup in cloud using the Amazon Web Services (AWS). They wanted their document management system to have customized functionalities like PDF conversion on Check-in (major or minor versions), versioning history, notifications, along with enhancements like a folder structure getting created at one-click, scope-based search and an approval process with e-signatures.
The main objective was to have a document management system on their cloud environment.
- So, designing an architecture for their systems and its configuration.
- Login Module with customization
Along with this, the following mail functionalities and features were to be delivered in the custom solution:
- A custom Layout on the root and the subsite for the same look-and-feel.
- A Custom scope-specific search
- Drag-and-drop functionalities in the file management system.
- Versioning on the document
- PDF conversion on Check-ins of the systems.
- Directly creating the CTD documents for the system itself.
- A functionality to replicate the same older structure at one-click
- An approval process, with an e-signature as an approval.
GlobalSubmit had their system setup on the cloud with the help of Amazon Web Services (AWS). So, an architecture was designed, with all the application tiers, a search server and database servers in the SharePoint farm. So, as per the design, a new SharePoint farm was configured. Then, all the application tiers, database server, search server, etc. were configured in the farm.
After the SharePoint environment was setup, a custom solution was developed, using Microsoft Visual Studio and SQL server. This one-click solution consisted various application pages, features, visual web parts, REST APIs, master page, event receivers, external content types, page layouts, user controls, branding components like css and jquery, site templates, Nintex workflows, etc. Also, we used PowerShell scripts to automate and make this a one-click solution.
Beginning with the solution, a custom login module was developed for their use in various organizations. This was developed using Thinktecture Identity Server model architecture. This Thinktecture was integrated with the SharePoint farm and the custom solution for the authentication and authorization.
GlobalSubmit wanted a system, which could have a dashboard like page, containing the tasks assigned to the user, as well as, the recently modified documents along with the management of the page. This page had the same layout across the site and they wanted to have multiple subsites having the same structure, with the data specific to that particular product while a mix of all the tasks from all the subsites on the root site. So, this SharePoint custom solution was developed for a root site as well as for the product subsite.
The root site and the product site had a custom master page, containing their branding for the top navigation, as a user control, and left navigation, from the OOTB SharePoint components. Along with this, a drag-and-drop functionality was developed for the ease of the users. Moreover, the custom search was developed to perform a scope-specific search (root level as well as subsite level).
GlobalSubmit wanted to create a new site for each new product. So, from the root site, GlobalSubmit was provided a functionality, that could create a new Product site, as a subsite, having the same layout as the root. Moreover, this subsite had the document libraries, calendar, task lists, etc out-of-the-box (OOTB) application automatically configured.
In the document library, the common out-of-the-box functionality like Check-in, Check-out, workflows using Nintex, version history and the file metadata features, were developed to have the same look-and-feel as provided by SharePoint OOTB but with the customizations. Apart from this, there was a feature of converting the Microsoft Word document to PDF, developed, on major & minor check-ins, creating multiple copies (PDF and MS word) and versioning history getting maintained for each of the copy.
GlobalSubmit followed a predefined set of procedures, having documents labelled per their stage and progress. So, for each product, the custom solution created folders in the document library as per their stages.
They had various forms and CTD documents to be submitted as per the norms and policies. So, we created new custom content types, based on these CTD documents, called the CTD templates, to ease the process of filling up the details, and the approval process.
If any stage had multiple advancements in the stages, the particular folder structure could be replicated with a different advancement version of the same. This "repeat section" functionality would help the users to easily replicate the folders structure at that very moment, reducing the time consuming and tedious process of creating the same folder structure again.
E-Signature feature was also developed to have an approval process using the Nintex workflow which was developed and integrated to SharePoint. This feature, would send a notification mail to approvers. The approvers can review the CTD document and if approved, can apply for E-signature, which would get appended to the document. Along with this, a new document is added to the record library, with the e-signed document, along with a new version. This process would repeat every time the workflow executes.
An audit log functionality was developed for the admin users, in order to have a check on the documents e-signed/approved by the approvers.
With this one-click SharePoint custom solution, GlobalSubmit gets all the manual, time-consuming and tedious process from creating a product, getting it in stages, managing the CTD documents, approvals through e-signatures, and maintaining versioning history automated and simplified using Nintex workflows.
An automated document management system having the same look-and-feel
Easy creation of CTD documents along with replication of folder structure
Quick and automated approval process with e-signatures.
Our proven methodologies and a track record of excellent services backed with by years of experience with SharePoint will ensure a high success ratio and a greater user acceptance.
Let us know what you are looking for and get a quick quote from our SharePoint team!