How Qualifyze Uses AI and Data to Transform Supplier Risk Management in Pharma Manufacturing

“Risk is always a function of volatility. And I think everyone agrees that volatility in markets, also in the pharmaceutical industry with regards to tariffs, has actually increased,” explains David Schneider, CEO of Qualifyze, discussing the evolving landscape of supplier qualification and risk management.

The technology company has built the largest global dataset of supplier audits, combining traditional compliance approaches with AI-driven insights to help pharmaceutical companies make faster, more informed decisions about their supply chains.

In this PharmaSource podcast episode recorded at CDMO Live 2025, David and Chief Product Officer Martin Lehmann. share how pharmaceutical companies can leverage technology and data to navigate increasing supply chain complexity, reduce qualification timelines, and transform reactive compliance into proactive risk management.

Rising Market Volatility Demands New Approaches to Supplier Risk

The pharmaceutical industry faces unprecedented uncertainty, particularly around trade policies and supplier relationships. Recent developments have fundamentally changed how companies approach their supply chains.

“If companies work with a certain set of suppliers with their current supply chain, the question obviously comes up: Am I still able to work with the same suppliers, with the same setup, at the same economic conditions? And the answer that many of the companies are giving now is probably not, but we don’t really know,” David explains.

This uncertainty creates a cascade of challenges. Companies must evaluate alternative supply chain configurations, often limiting their supplier options to specific regions. The qualification process becomes more complex, potentially requiring new regulatory registrations, whilst FDA process changes add further delays.

“Generally, I would say risk levels have been increasing. Qualifications are probably becoming more complex. They will take longer and people are now looking for alternative ways to compensate basically for this risk and essentially by using technology to speed up processes, to learn faster, to connect data points, to make faster decisions,” David notes.

Moving Beyond Traditional Audits with AI-Powered Insights

Qualifyze’s approach represents a significant departure from conventional audit and compliance models. The company started as a traditional auditing firm but quickly recognised the limitations of point-in-time assessments.

“We started as a pure auditing company in the early days. Very quickly on, we started adding a technology layer on top, and I think this is really unmatched in the industry,” David explains.

The transformation involves combining audit data with artificial intelligence to generate strategic insights rather than merely fulfilling compliance requirements. Martin elaborates on this evolution: “By essentially combining all those data points with AI, with technology, we’re able to derive more strategic insights. I would say moving from a ‘nice to have, I just need to do more audits to be compliant’ more towards a strategic lever.”

This approach addresses a fundamental limitation of traditional auditing. “Audits are only a snapshot and proactive risk management goes beyond that,” Martin explains. “It doesn’t just look at compliance where audits are perfectly fine, but leave gaps in risk management. Proactive risk management looks to stay ahead of issues and work with suppliers to really address potential risks before they turn into issues.”

Breaking Down Silos Through Data-Driven Collaboration

One of the most significant challenges in pharmaceutical supply chain management is the disconnect between quality, procurement, and supply chain teams. Each department often works with different tools and datasets, creating inefficiencies and missed opportunities.

Martin addresses this challenge directly: “People and teams naturally want to collaborate. Most people that we work with, most teams are really trying, but historically they’ve been held back by processes and tools which silo information and silo the way that things are done.”

Qualifyze’s platform addresses this by aligning stakeholders around shared data whilst respecting departmental needs. “We align stakeholders around data. Not only do we give everybody access to the platform independent of the department, so you can add any user to look at the same information, but we’re also making the information available through technology, through an API, through other means of connecting,” Martin explains.

The result is coordinated decision-making across departments. “Quality makes decisions around supplier performance from a quality perspective. Procurement looks at optimising their sourcing strategy and supply chain can, for example, look at changing their batch testing strategy if they see early signs of decreasing quality in a supplier.”

Accelerating Decisions with Quality Insights Platform

The company’s Quality Insights platform demonstrates how data can transform pharmaceutical manufacturing decisions. Built on what the company claims is the world’s largest audit dataset, the platform helps teams answer critical strategic questions.

“In terms of decisions that are being made or the questions that our customers need to answer, it’s really how risky is my supplier portfolio, number one,” Martin explains. This fundamental assessment drives resource allocation and audit planning decisions.

The platform also supports faster product launches by enabling more informed risk assessments. “How can I accelerate or de-risk product launches? If I have a view of this information in a way that I can easily digest it, I can make a decision around: Is it sufficient that a supplier that I’m working with is actually pre-qualified and I don’t need to wait for the full official qualification process to end before I work with them?”

Strategic sourcing decisions represent the third major application. Given current geopolitical uncertainties, companies need better market intelligence about supplier risk profiles. “Being able to have a market view of risk data on suppliers and being able to benchmark similar suppliers really, really helps to have a better strategy in place,” Martin notes.

The Future of Pharmaceutical Compliance

Looking ahead, David anticipates significant changes in regulatory expectations, particularly around supply chain visibility and data requirements.

“What we’re actually seeing at regulators is that they’re trying to build something that actually looks at linking different players in the supply chain. So not just looking at your tier one risk, but actually going all the way down,” David explains.

This evolution will require deeper supply chain analysis and more sophisticated data management. “In the future, things will be much more digitised. So it will not just be ‘show me an audit report’, but actually ‘show me data, show me how you’re complementing your risk assessment. What additional sources are you actually using to form your opinion?'”

The transformation represents both challenge and opportunity. “The expectation is actually significantly going to go up on this side, but it will obviously also take time, which I think is good for the industry,” David concludes.

For CDMO leaders navigating these changes, David offers practical advice: “Challenges always represent an opportunity and I think actually now is really the time to take a step forward, really set yourself apart on a variety of different items. I really believe now is the time actually to invest and to actually go ahead, stand out from your competition by being actually proactive.”