Tram break lights on rail at night
CASE STORY

Delivering GxP Documentation Compliance Across Quality & R&D with Veeva QualityDocs

The Challenges of Managing Quality Documentation

A mid-sized pharmaceutical company was managing and storing quality documentation in a legacy document management system that was going out of support. The team conducted an evaluation of available options in the marketplace and participated in product demonstrations. Through these activities, they selected Veeva QualityDocs as their new solution to manage GxP documents and supporting workflows.

Continuing issues with our client’s legacy solution motivated the team to move quickly. Additionally, as they approached the summer holiday season, they didn’t want to lose momentum around the project. These influences added pressure to quickly complete the organization’s move to Veeva QualityDocs.

A Thoughtful Approach Ensures Minimal Business Disruption

While the Veeva team managed the implementation of Veeva QualityDocs, the pharmaceutical company contracted with NNIT for other aspects of the project to ensure they would meet their project goals within the required timeframe:

Project Responsibility:

  • NNIT supported the migration of documents from the current document management system to Veeva QualityDocs.
  • NNIT helped in the identification of source locations for metadata and pulling metadata for use by the client’s Business Analyst to support automated migration
  • NNIT consulted, advised, and built the integration to MuleSoft which is middleware to the identification and access management (IAM) solution

 

After go-live:

  • NNIT supported the hypercare period, working closely with Veeva and the client to ensure continuity
  • NNIT provided application support including configurations, integrations, business advice, and development of supporting KPIs and KBAs
  • NNIT ensures that Veeva QualityDocs stays compliant as part of the Veeva releases and the client’s enhancements
  • NNIT delivered application management services including but not limited to change controls, license management periodic reviews, audit trails, disaster recovery testing, daily checks, and project management.

 

To complete the migration within the allotted timeframe while still supporting ongoing business needs to access certain documents in the repository, NNIT and the client agreed to perform an initial migration of most of the documents into Veeva QualityDocs. This was followed by a delta migration to bring over the remainder of the documents. This strategy involved significant coordination and planning to allow for proper validation and testing.

Seamless Support and Continued Collaboration Define the Solution

As a strategic partner and trusted advisor, skilled consultants from NNIT’s Veeva Center of Excellence collaborated with the client to address migration, integration, and technical testing requirements. As the system went live, they used NNIT’s proven transition framework to shift services to application support, validation support, and application management.

Later, NNIT expanded its technical support program to ensure consistent coverage to support the US and EU sites. NNIT delivered proactive support and optimization of the Veeva suite while successfully resolving 100% of support tickets according to the service level agreement (SLA) targeted response times.  

Throughout the project, NNIT developed a detailed understanding of the client’s systems, processes, and goals. They worked closely with the client to meet their timelines and successfully deliver the Veeva QualityDocs system.

After go-live, NNIT has continued to support the client with advisory and implementation of configuration changes that support the evolving requirements of their document management system. The combined teams collaborate closely to help the client take full advantage of their broader Veeva investment with support for the Veeva Vault RIM and Veeva Vault Clinical suites.  

“NNIT has provided ongoing support and flexibility as our needs have evolved. Their Veeva expertise has enabled us to scale quickly and get more from our Veeva investment.”               IT System Owner and Associate Director GxP CoE Operations, Mid-Sized Pharmaceutical Company

Contact us to learn how our experience can help your team get more from your Veeva investment.