A commercial biotech client had recently implemented Veeva Quality Management System (Veeva QMS) and Veeva QualityDocs to transform the Quality function and support the eventual launch of a second commercial product. Given that these systems were critical for fueling the growth of the business, our client was keenly aware of the need to develop the process, tools and team needed to maintain and enhance this technology while ensuring the systems remained compliant.
Accordingly, our client asked us to help achieve this goal—specifically, the maintenance and enhancements (M&E) process needed to effectively organize, prioritize, and implement the requests coming in from the business. Not only did we establish and roll out this process, we assembled the team needed to sustain it and we built a tracking tool in Smartsheet to help manage and track requests and the accompanying metrics. Within one year, we significantly increased the percentage of requests implemented as well as the speed in which requests were completed.
What We Did
1. Defined the Process
To start, we worked with our client to obtain the vision and high-level requirements for the M&E process. From there, we combined our knowledge about the client’s IT organization with Veeva M&E best practice to develop a detailed, step–by–step process by which requests were to be received, assessed, prioritized, and deployed. We captured this step–by–step process in MS Visio to allow our client to easily visualize what it would entail.
2. Assembled the Team & Created the Tools Needed to Sustain the Process
Once the process was defined, we identified the roles needed to uphold and sustain the process, including a business process owner, business lead, IT lead, and configuration specialist. With the help of our client, we appointed specific individuals to serve in those roles and met with them to align on expected responsibilities. Additionally, we devised a maintenance and enhancements tracker in Smartsheet that clearly organized all requests, provided transparency into the status of each, and allowed us to seamlessly track key metrics, including volume of requests received, percentage of requests implemented, and business days elapsed between receipt and implementation.
3. Rolled out and Managed the Process
Lastly, we hosted a formal kickoff with the core team described above—from there, the business process owner and business lead helped to communicate to their end users that this process was now live, and that they could submit requests to our team following the process we had architected. We proceeded to drive the management of the process, updating and maintaining the tracker and ensuring communication amongst all members of the M&E team.
Client Results
Within just nine months, our client materially increased the throughput of enhancements completed while substantially reducing the time required to complete them.
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Requests delivered
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Reduction in average time to deliver (from 30.5 days to 14.5 days)