The Top 3 Quality Challenges for 2019

January 7, 2019

By Sparta Systems


Compliance is still king…for now.

The Sparta Systems 2019 Pharma Quality Outlook Survey gathered insights from 161 pharmaceutical industry professionals functioning on quality management teams. The results from the survey outline the top six goals and obstacles facing quality teams in 2019.

1. Maintaining Compliance

Compliance remains the top priority for quality teams in 2019. Manufacturers in the life sciences must comply with complex and rapidly evolving industry regulations to sell and market products. Failure to achieve regulatory compliance not only hinders the bottom line, but also jeopardizes patient safety and satisfaction.  In addition to rapid response to evolving industry regulations, 48 percent of survey respondents reported challenges of limited headcount and budget constraints. While compliance has been the top priority of quality teams for years, recent trends suggest that firms are able to check the compliance box by focusing on economic performance.

2. Improving Economic Performance

This year’s survey indicated a stark rise in performance as a driving force for quality teams in 2019.     Though compliance reigns king, firms are beginning to move towards performance-based quality due in part by Industrial Transformation.  In fact, 39 percent of pharmaceutical manufacturers cited economic performance as a top priority in 2019. As performance becomes a higher priority, its challenges increase. 35 percent of respondents reported a lack of communication and collaboration tools as a barrier to economic performance goals, which stimulates the next challenge facing quality teams in 2019: cutting department costs.

3. Reducing Department Costs

In the Digital Era, quality teams recognize the value of innovative technology and accurate data for process automation, centralization, and integration. Pharmaceutical quality teams must navigate the fine line between budget constraints and the industry’s shift from compliance to performance. 31 percent of survey respondents reported timely data analysis and reporting capabilities as a top obstacle in 2019 as sophisticated reporting capabilities can be costly.  Data remains the foremost driver for quality improvement in 2019, sparking the need for greater tech investments, and ultimately, cost cutting. 15 percent of survey respondents plan to purchase an integrated enterprise

quality management system in the next 12-16 months, and 12 percent assert that a cloud-based/digital platform is a top consideration for tech investments in 2019.

The Sparta Systems 2019 Pharma Outlook Survey revealed the industry’s push towards Digital Transformation in the coming year to drive economic performance and remain competitive. 

For the full list of 2019 quality goals and obstacles, check out this infographic:

Read The Sparta Systems 2019 Pharma Quality Outlook Survey to learn more.

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