Quality Management System software provider Sparta Systems released a new report analyzing goals and obstacles facing pharmaceutical executives when it comes to their quality management teams. The research, based on a survey of 160 pharmaceutical executives, revealed that while compliance remains the top quality objective for 2018, nearly 40% of professionals listed impacting economic performance as a top objective and almost half of respondents anticipate using quality data to improve manufacturing performance.

While these signs point toward the evolution of the traditional quality management function, there are still major barriers to success. Brandon Henning, director of product management at Sparta Systems, gave us a better overview of the report by offering up additional findings as well as insight on how quality is changing within the pharmaceutical industry.

Key Findings

• The biggest challenges to existing quality systems were “ensuring system is compliant with regulations” (60%), “usability and scalability” (34 percent) and “training users” (30 percent). 

• Limited headcount (49%), limited budget (44%) and data analysis and reporting capabilities (31%) were the top obstacles to achieving 2018 objectives.

• More than half (51%) of respondents have defined objectives related to quality data management and analysis.

• Only 14% of respondents anticipate purchasing best-in-class quality software in 2018.

• Half (49%) of respondents anticipate using quality data to “improve manufacturing performance” in the next 12 to 16 months.

Q: Let’s take a step back, what do quality departments in pharmaceutical companies do, why are they important?

Brandon Henning: The main goal of quality professionals in the pharmaceutical industry is to ensure their companies are compliant with the ever-changing world of regulations. Without quality, it would be virtually impossible for a pharmaceutical company to sell products. Quality teams vary from company to company, but essentially, they are responsible for the initial submission of all tests to getting the product ready for sale and then ensuring the product meets quality and regulatory standards set forth by the FDA or any other regulatory group.

Q: Based on the report’s findings, the role of quality appears to be changing, and quickly. How is that role changing?

BH: Traditionally, the role of a quality department was focused solely on compliance, but the reality is that quality management has the ability to do far more than just checking the compliance boxes for pharma companies. Due to external global pressures, the role is shifting from just being focused on compliance to also supporting the business and helping drive operational capability and efficiencies. This switch allows pharmaceutical companies to focus on better operational metrics, getting products to market faster, and drive down manufacturing costs. As quality teams shift their focus to performance-oriented goals, we expect to see senior executives increase investments towards continuous improvements such as hiring and implementing new quality systems. This would be a major relief for the 49% of respondents that named limited headcount as an obstacle to achieving 2018 objectives.

Q: Almost half of respondents named economic performance as a top quality objective. What do you make of that?

BH: This is a very positive sign as performance-oriented goals often impact revenue generation, which is typically a top objective for senior executives. Aligning quality department goals with corporate objectives can help secure funding for continuous improvements such as headcount, training and software solutions – some of which respondents named as obstacles this year. These additional resources can help quality teams increase their impact on company-wide performance while streamlining compliance efforts.

Q: What was surprising to you from this report?

BH: While we know budget is a major obstacle for quality teams in 2018, it was interesting that only 14% of respondents claim to be in the market for a best-in-class quality system. Teams that aspire to affect change will have to establish the needed people, processes and technology for that change. While a less expensive solution may solve short term budget issues, quality teams need to think about the long-term view of a best-in-class quality system. Using cumbersome systems to continuously monitor compliance drains resources that could be used to impact company-wide performance.

Q: Quality data was another area respondents put emphasis on regarding their objectives for 2018. Can you go into more detail as to why quality data is so important and how it can be used?

BH: Having quality data eases the burden of compliance and helps support cross-functional collaboration, both in-house and throughout the supply chain. As regulators take a more data-driven approach, having a quality system supports the ability to gather the vast amounts of regulatory information required. Quality data is critical to the success of quality departments and having access to it in a timely manner —especially analytical data—helps them quickly understand where a problem exists and where it may be trending so that they can be more proactive in resolving it.

Q: What are some of the ways quality teams can help their organizations beyond their traditional role of managing compliance and begin to impact company-wide performance?

BH: The first thing quality teams need to do is identify their champion – who is the key decision maker that will influence and be onboard with the quality objectives. Investing time to identify how your objectives on the quality team align with your champion’s team is crucial – are they looking to reduce internal costs? Increase profitability? Reduce supplier related costs? Get new products to market? Collaboration is another key in making compliance a company-wide initiative. It’s about building a framework for the teams or departments that could benefit from quality insights. It’s the job of the quality team to make cross-functional teams understand the value of quality data and how to interpret that data to create actionable insights and metrics. Once other teams are onboard, a reporting framework will help guide these teams into what benchmarks look like, what goals can be achieved and what the ROI is.