Proactive Quality as a Business Advantage

The changing role of quality operations within the life sciences industry — and the move to predictive approaches and Quality 4.0 — inspired insightful discussion at the Veeva R&D and Quality Summit, Europe. As companies focus on high value, low volume products such as gene therapies, and outsource strategic functions, more of them are improving quality management by moving from manual and paper-based processes to streamlined digital systems.

Transforming quality from a reactive to a proactive function

Experts shared how technology is helping transform quality from a reactive to a proactive function. “The industry is starting to realize that quality can be a competitive advantage,” Regis Simard, president of supply chain at GSK told attendees in his opening keynote. As outsourcing extends quality ecosystems far beyond each company’s borders, advances in real-time data exchange are moving the industry closer to predictive analytics, deepening collaborations between supply chain partners, Simard said.

Companies just moving into commercial stages have the advantage of building connected data and documentation using modern quality solutions from the start. Argenx’s management team, for example, wanted to start with an ecosystem of unified and connected applications. Klaas Boone, senior director of business information systems, noted that the company streamlined end-to-end business processes by implementing five applications across Veeva Vault RIM, Veeva Vault Quality, and Veeva Vault Clinical Suites, to enable the right start.

Getting past the paper-digital conundrum

For large and established manufacturers, manual practices and siloed data continue to challenge quality improvement efforts, even for companies that have been working on digitization for years. “Companies need to join different databases and platforms, in a controlled way, for seamless exchange of information,” said Marcus Massingham, senior director of quality systems at GSK.

At most companies today, quality departments still use hybrid approaches that combine digital and paper processes. As Massingham noted, it can take a shocking amount of time for data to go from its source to someone who needs it to plan or make a decision. Fragmentation is another problem, he said. “A piece of data or documentation may be coming in electronically, but someone still has to sign it or to track it manually,” he said.

At this point, GSK is prioritizing its modernization efforts by focusing on real-time or near-real-time access to data and having the right controls in place to improve decision making, said Massingham. The company is also mapping workflow with contract partners, particularly in areas such as logistics.

AstraZeneca is tackling data siloes head on with ambitious programs on both the R&D and the manufacturing fronts. In R&D, the company has implemented Vault QMS to increase the efficiency of audits and CAPA, replacing a homegrown tool that used spreadsheets, Microsoft SharePoint, and databases and required manual data transcription.

On the manufacturing side, AstraZeneca is rolling out a Global Product Quality System (GPQS) to standardize and harmonize its approach to quality data management, replacing 18 different systems that placed a large data analytics burden on the business. “We’ve had lots of siloed systems managing siloed processes, making it very difficult to get clear oversight without having to spend hours and hours going through multiple systems to get the data,” said Andrew Sharrock, quality director at AstraZeneca.

The new system will work across sites, quality teams, contract partners, logistics providers and suppliers and extend into R&D and the supply chain, he explained, noting that this approach has already been externalized for supplier audits.

Modernizing training and SOPs

Employee training is crucial to improving quality, and experts agreed that modernized approaches are needed. Merely having a new hire read a stack of text-dense SOPs to complete training requirements doesn’t ensure competence. Experts from Alvotech, a biopharmaceutical company using Vault Quality Suite, shared how they increased the effectiveness of on-the-job training. About 10 years ago, the company moved beyond the “read and understand” level to quizzes, but saw that regulators wanted more evidence of operators’ and technicians’ subject mastery. The company responded with a new system in Vault Training that balances instruction and skills demonstration. The content is now in digital form, but the company is working to further reduce the need for manual intervention from instructors.

Moving from text-heavy paper or PDF SOPs will also be crucial to bringing Quality 4.0 into the heart of pharma’s quality systems. Heike Roeder, director of Deloitte’s Risk Advisory Group sees SOPs evolving into “user-friendly information management systems” that convey the right information to the right people in the best format via a combination of video, voice, and text.

Better quality metrics drive operational excellence

Regulators are helping the industry define and better assess quality performance and quality culture maturity. In 2016, the US FDA launched a Quality Metrics initiative to aid in both these areas and is working with the Institute for Technical Management at the University of St. Gallen, Switzerland, on this project. Research associate Mark Grothkopp discussed efforts underway at the Institute and key findings. As was clear from his presentation, quality performance improvements facilitate gains in operational excellence. The Institute’s studies have underscored the importance of “quality enablers” defined in ICH Q10, including quality risk management, knowledge management, and CAPA. These enablers correlate not only with quality culture maturity, but with improved compliance, and in the development of a more holistic approach to quality over time, said Grothkopp.

Using artificial intelligence algorithms and quality data, the Institute has predicted the outcome of regulatory inspections, and companies can track some of the KPIs used in the research to prioritize their own internal audits. Meaningful metrics are needed to drive performance improvements as well as organizational advancement, Grothkopp said. In the end, examining the human side of quality and developing a quality-focused culture will provide the foundation needed for Quality 4.0 and other advances in the future.

View quality sessions from the 2021 EU R&D Quality Summit Connect on demand.