The findings of the survey are discussed in a newly issued report entitled 2018 Pharma Quality Outlook: The New Role of Quality Teams. The research cited therein suggests that the role of pharmaceutical quality departments is quickly changing as executives look to enlist the skillset of these teams to better support the business by driving operational efficiency, improving manufacturing performance and accelerating time-to-market, among other objectives.
"The role of a quality teams is changing for a number of reasons such as global pressure, generic drug competition, and budget cuts," said Brandon Henning, director of product management at Sparta Systems. "These changes are driving companies to be more efficient by looking more closely at how quality impacts their business. We're also seeing regulators take a more data driven approach, so having a quality team and system that supports these demands is going to become crucial for success."
Alongside key objectives for a successful quality team, the report cites barriers to achieving those objectives as well. Budget and headcount ranked as the top two obstacles in 2018, while compliance and validation was the biggest challenge with existing quality systems.
Key Findings
- The biggest challenges to existing quality systems were "ensuring system is compliant with regulations" (60 percent), "usability and scalability" (34 percent) and "training users" (30 percent).
- Limited headcount (49 percent), limited budget (44 percent) and data analysis and reporting capabilities (31 percent) were the top obstacles to achieving 2018 objectives.
- More than half (51 percent) of respondents have defined objectives related to quality data management and analysis.
- Half (49 percent) of respondents anticipate using quality data to "improve manufacturing performance" in the next 12 to 16 months.
To access a full copy of the report, please visit: https://go.spartasystems.com/2018-Pharma-Quality-Survey.html
Survey Methodology
The survey of 160 industry executives has been compiled into a full report detailing pharmaceutical companies' goals and objectives for quality control and assurance in 2018.