Migration to our own Regulated Content Management

"Edge Regulated Content Management was the choice for us because the intuitive interface integrates quite well with our Box platform. There was no additional training we had to give our users because they were already familiar with the platform interface."
Medidata RCM User, Hailey Lewis, VP of Regulatory and Compliance, Zosano Pharma

100%

Confidence for document integrity from source to destination

850,000

Documents Migrated

1800

Active Users

The Challenge: Migration from Veeva Vault to Edge Regulated Content Management

In February 2017, Medidata began the migration process to remove our data from Veeva Vault into Edge Regulated Content Management (our own RCM product). The migration team was assembled with a cross-sampling of Medidata employees, including team members from technology, service delivery, information security, global compliance and strategy, professional services and enterprise technology. In addition to the internal migration team, Medidata partnered with a veteran external content migration partner, Valiance, to begin the migration process.

The first challenge the team faced was API limits imposed by the legacy system, Veeva Vault: extracting documents was initially estimated to be a lengthy, eight-week process. The Medidata team was able to increase system performance and extract documents from Veeva Vault in just six days — requiring only two days to load the data in Edge Regulated Content Management— which was a much quicker implementation process than the initial eight-week expectation.

The Solution: Edge Regulated Content Management

In total, Medidata extracted and validated 850,000 documents and their corresponding metadata in the migration process. These records included SOP, WI, Policy, Forms/ Templates, Validation documentation, Qualification documentation and Client eBinders ranging in size 1.5MB up to 1.6GB. To ensure 100% confidence for document integrity from source to destination, Edge Regulated Content Management has implemented an additional hash validation level checkpoint — in addition, to document count matching.

 

The Results: Better Understanding Key User Needs Leads to RCM Product Acceleration

With 1,800 Medidata users active in the system, the Edge Regulated Content Management team quickly adapted to user feedback and focused efforts on improving key areas of importance to end users. The first lesson learned involved making enhancements to the Single Sign-On capabilities and set-up between Okta and Edge RCM, as this was critical for the simple and intuitive user experience. Improving index, search and filter functionality was identified as important to the user, as well as a clean and simple favorites feature. The Edge RCM team also refocused their attention to creating flexible roles and permission levels for the users during the migration process.

The migration of 850,000 documents into Edge Regulated Content Management was no easy task — but with a robust, diverse and quality-driven internal team, along with content migration partner Valiance, Medidata reduced the extraction and implementation process from eight weeks to eight days. Medidata can now echo our customers who have reaped the benefits, including Hailey Lewis, VP of Regulatory and Compliance at Zosano Pharma. “Edge Regulated Content Management was the choice for us because the intuitive interface integrates quite well with our box platform, which we adopted several months ago,” she said. “There was no additional training we had to give our users because they were already familiar with the platform interface. Having our documentation in a secure, validated environment enables an ease of use for authoring, review, and approval, which compliments the work we do and enables us to pay attention to other things so we can focus on our product development.”