06 Apr

Delivered 54 Quality System Enhancements and 3 Major Releases In 10 Months

Abby Grable Case Studies, Change Management, Post-Go Live Support, Quality IT

Delivered 54 Quality System Enhancements and 3 Major Releases In 10 Months

A global health sciences organization had recently onboarded a newly acquired brand onto their Veeva QualityDocs platform. To ensure the system met the needs of this new functional group, it was critical that they overhaul their existing maintenance and enhancements (M&E) process to make it more robust, organized, effective, and compliant. Additionally, to reduce the manual burden, it was vital that the process be automated to the extent possible via the client’s ServiceNow platform.   Our client tasked us with doing exactly that—as a result, we enhanced user adoption and satisfaction, drove configuration of critical workflows and lifecycle enhancements, and coordinated the successful implementation of three major system releases with no interruption to business operations.

1. Redesigned the Existing Process

We met with the individuals running the existing M&E process to understand what the current state process entailed, who was involved, and what tool(s) were being used to manage and track requests. These conversations illuminated that some structure was already in place, but that it lacked the robustness needed to manage the volume of requests coming in from the business, including the newly onboarded user group, in a timely manner. Accordingly, we redesigned the process to meet those needs.

2. Assembled the Team & Created the Tools Needed to Sustain the New Process

From there, we leveraged best practices to identify the roles and responsibilities needed to sustain this process, including a business process owner, business lead, IT lead, and configuration specialist. With the help of our client, we identified the individuals who would be best suited to serve in those roles, and we socialized the corresponding responsibilities with each of them. Additionally, we built a tracker in Smartsheet to help organize, prioritize, and report on status of all enhancements.

3. Rolled out, Managed, and Automated the New Process

We formally rolled out the process and informed all process stakeholders of how to submit and follow the status of their requests. Additionally, we oversaw the process to ensure it operated smoothly and that requests were driven to closure. Lastly, we automated the process by collaborating with the IT Operations team to build the applicable workflows in ServiceNow, allowing the client to oversee and operate this process with much less manual effort.

Client Results

In the first ten months, our client delivered more enhancements and platform releases than ever before, with no interruption to ongoing operations.
%

Requests delivered

Major releases delivered

%

Interruptions to the business

06 Apr

Decreased # of Days to Deliver Veeva Platform Enhancements by 52%

Abby Grable Case Studies, Change Management, Post-Go Live Support, Quality IT

Decreased # of Days to Deliver Veeva Platform Enhancements by 52%

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 submitrequests 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.

Requests delivered

%

Reduction in average time to deliver (from 30.5 days to 14.5 days)

25 Jun

Transitioned 1,500 Users to QMS

Abby Grable Case Studies, Change Management, IT Strategy, Quality IT

Transitioned 1,500 Users to QMS

Our global Nutritional Science client needed to integrate their largest U.S. brand into their IT ecosystem, which required 1,500+ users to transition off their current Quality Management System (QMS) Oracle Product Management, onto Veeva QMS.

In doing so, the client sought to harmonize business processes such that all brands would follow future state workflows. With the expected kickoff date just three weeks away, the client needed us to hit the ground running immediately.

What We Did

  • Developed process harmonization approach and workshop calendar, and socialized with project team
  • Developed Harmonized Process
  • Developed baseline business processes for Deviations, CAPAs, Change Control, and Product Complaints to facilitate workshops
  • Set objectives and expected outcomes with stakeholders through a workshop kick off before the workshops started

Client Results

 

0
Processes Changes
Brand agreed to adopt harmonized processes completely as-is
0
New Requirements
Very few, new business requirements were identified by brand team
0
Validation Scripts Required
Due to adoption of processes, requirements, and the system as-is
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