Recaps of sessions from Sparta’s CEO, PwC, Greenleaf Health, and product update

Sparta Systems hosts an annual customer conference, Sparta Connection. For 2020, this conference moved to a virtual series. Tuesday, June 9, the online sessions kicked off with a warm welcome from Sparta CEO Dana Jones, who shared messages of thanks to customers, especially those in the life sciences contributing to Covid-19 responses. Of this unique moment, Jones said, “It’s a time where we are proud to serve with you and to provide and facilitate what you need, given the hard work, given what you’re doing to move our lives forward, to save lives, and to give us hope for a brighter future.”

Next, virtual emcee and Sparta VP of Digital Innovation, Stephen McCarthy, introduced Kareem Elwakil and Jan Paul Zonnenberg of PwC, who dove deeper into how Covid-19 is transforming the quality landscape.

Elwakil described how the phases of action in a crisis are to respond, recover, evolve – and that it’s possible different parts of a business could be in one or more of the phases concurrently. He noted that many organizations have gone through the Respond phase, having implemented contingency planning, to some degree, and weather the storm of the last few months. Those companies are entering recovery, as ramp back to normalcy. An example would be reallocating resources in critical areas to other areas, to recover from crisis.

To evolve, Elwakil asked us to ask ourselves, how can we use this as a springboard for the future? “How do I emerge stronger?”

Zonnenberg, a partner in PwC’s Life Sciences Practice, said, “Longer term, post this crisis, we see a major shift in the supply chains of most pharmaceutical and medical device companies. We’ll see more multi-sourcing, we’ll see more onshoring, we’ll see need for technology transfers, we’ll see the need for more laboratory testing. And our role as quality professionals, is to enable the supply chain changes at a pace that we haven’t seen before.”

He suggests codifying a new way of working that can incorporate or continue changes made in response to crisis. “I would encourage us to try to understand the root causes of why sometimes we are doing better today than in the past, in our operations,” Zonnenberg said. “Usually we do root cause analysis when something goes wrong, but let’s do a root cause analysis on what’s going right, and how we can learn from that. How do we institutionalize what is going well, into the future, so we can learn and become a better new normal?”

In light of that, the conversation turned to how quality technology transformations are included. Elwakil said, “If anything, this crisis has shown it’s very important to have a strong digital backbone to enable your business processes. And more specifically in this context, your Quality system processes.” He added, “Digital Maturity is one of those ‘No Regrets’ moves. There’s very little that can go wrong. And pretty much 100% return on investment when it comes to investing in your digital maturity. It will deliver dividends.”
On Wednesday June 10, Sparta welcomed Cynthia Schnedar of Greenleaf Health for a spirited conversation about regulation and fostering a culture of quality.

Schnedar, formerly of US FDA and US Department of Justice, had unique perspective to share, with her experience as a regulator and seeing how quality plays out not just with the companies interacting with FDA, but also quality management within government itself.

In speaking to creating a culture of quality within an organization, Schnedar stressed the importance of communication in driving home company values and how to live those values in quality management. Leaders shouldn’t be shy to repeat themselves on these points.

Quality goes beyond manufacturing and supply site compliance, she said, and she described the importance. “You need to have that culture where there’s a reward for bringing problems forward, and people understand that’s the right thing to do. Whistleblowers need to be recognized as bringing value to the company. Otherwise, no one is going to be brave enough to bring a problem forward, instead they’ll be afraid that they’ll be blamed.”

Schnedar asks quality managers to make that culture shift a personal priority, and to listen. “Walk the talk and respond. Model behavior.”
Closing the first week of the virtual conference, on Thursday June 11, Sparta Systems’ own Hari Subramanian, VP of Product Management, and Mike Edwards, Director of Product Management, gave a close look at what’s ahead for Sparta’s quality management solutions.
Subramanian began by connecting the present and growing patient-centric model of care and manufacturing and quality. This shift has driven an increased pace of innovation. Some examples include the rise of personalized medicine, the use of 3D-printed devices, and the shift in manufacturing from batch to continuous manufacturing.

In order to keep up with these emerging trends, Subramanian said, “They would require innovating the QMS to meet the evolving needs of the marketplace and enable digital transformation.” This includes leveraging insights from real-time data – from the lab, from the shop floor – to gain the necessary insights to drive business outcomes. Customers need the ability to manage quality across their virtual network, from research to commercial and post-market.

Subramanian and Edwards went on to describe the latest innovations in TrackWise Digital®, TrackWise®, and hybrid solutions.

Subramanian said Sparta is a pioneer in embedding AI in core quality management process to enhance decision-making. Many TrackWise Digital customers are extending quality with the use of Supplier Quality Management, Product Registration Tracking, Risk Management, and more. Quality managers can gain powerful business insights from the AI and machine learning capabilities to effectively prioritize events and automate operations.

Subramanian and Edwards also demonstrated mobile capabilities, describing how any remote worker can open a new event and how a quality manager can review, assign, and even electronically sign the event. Mobile quality makes things more efficient, reduces cycle time, and promotes that culture of quality that Schnedar of Greenleaf Health also talked about.

Upcoming, TrackWise 10, the next generation of Sparta’s on-premise solution, will also include AI enablement and intelligent forms. Sparta demonstrated their commitment to customer success with investments in TrackWise and continuing to provide flexibility while advancing capabilities.

Sparta also introduced the TrackWise Transfer℠ tool, which lowers risk for customers converting from TrackWise to TrackWise Digital, by automating the migration of data and configurations from on prem to TrackWise Digital. Sparta continues to support a hybrid solution for customers who want to leverage TrackWise Digital to extend quality processes and integrate to their on prem instances. Sparta is the only provider in the market to offer a hybrid solution, allowing you to find the right mix that will meet your business goals and end with proven, high-quality solutions.