For pharmaceutical quality teams, compliance with industry regulations has long been the top priority. But to enhance quality and achieve goals, these teams are shifting their focus to economic performance and data analysis.
According to Sparta Systems’ 2019 Pharma Quality Outlook Report, 66 percent of industry executives surveyed consider compliance as their top goal, a 10 percent decrease from last year. But 39 percent say that economic performance is one of their top objectives, a 4-percent increase over last year. Thirty percent say reducing department costs is another priority. The survey, released in January, surveyed 161 industry executives about the evolving function of quality management teams.
Compliance Versus Quality
Many pharma companies are mid-level in size — and “for these businesses, maintaining compliance can be challenging,” says Steve McCarthy, vice president of digital innovation for Sparta Systems, a Hamilton, New Jersey-based cloud and on-premise quality management software provider. And while companies realize the necessity of compliance, he says, the quality, safety and efficacy of a product are even more important.
“Does product do what it is supposed to do? Is there a continuity of supply? A major consideration when making a life-saving, life-changing drug is ensuring that you don’t run out of it because of a quality issue,” he says.
The quality function impacts a company’s entire value chain. “Companies with a really good product-quality record tend to have a strong compliance performance,” McCarthy says. “But the converse isn’t necessarily true.” Nearly half (47 percent) of respondents expect their quality budgets to increase in 2019, according to the survey.
Besides product quality, pharma companies also must maintain supplier quality. A rise in M&As and outsourcing is creating increasing numbers of suppliers, many of whom are contract manufacturers or boutique or innovative raw material and component suppliers, McCarthy says. Twenty percent of respondents say they plan to improve supplier quality management in 2019.
Improving data analysis offers pharmaceutical companies the opportunity to drive value. Nearly two-thirds (63 percent) of survey respondents say they anticipate using data to improve quality department performance this year, compared to 36 percent last year. And 58 percent (up from 41 percent last year) expect it to improve cross-functional performance.
Data also is useful in demonstrating compliance to the U.S. Food & Drug Administration (FDA) and other global regulatory authorities. A third (32 percent) of survey respondents say they anticipate using quality data to report to the FDA, indicating that data is becoming an increasingly critical part of regulatory compliance, McCarthy says.
Accessing the right data and knowing how to analyze it still be challenging for some pharmaceutical quality teams. According to the survey, nearly a third (31 percent) consider a lack of data analysis and reporting capabilities to be an obstacle in 2019, while 46 percent reported that accessing and analyzing data would be their biggest challenge.
Looking to the Future
As the pharmaceutical industry evolves, it is beginning to invest in technology that can improve efficiency, innovation and performance, McCarthy says. Small- and mid-level companies are joining larger firms in embracing Quality 4.0 — impacting quality performance through digital transformation and technologies like the Internet of Things and artificial intelligence, he says.
The survey found that while only 4 percent of companies are leverage Quality 4.0 technologies, another 43 percent say they plan to consider or experiment with them in the next 16 months. “Some of the bigger companies are building what we call the factory of the future, so they’re using the Internet of Things, sensors and the cloud, and they’re building in process control and continuous manufacturing,” McCarthy says, adding that other companies are shifting to the cloud and having products 3-D printed.
According to the survey, cloud systems are being used by 16 percent of quality teams. Additionally, 15 percent plan on purchasing integrated enterprise quality management software and 12 percent are considering a cloud-based/digital system as part of the quality management system during the next 16 months.