Three Critical Objectives for Pharma Quality Professionals in 2018

Increased competition, regulatory scrutiny and tightening margins have changed expectations for quality teams drastically over the last several years.

By Brandon Henning, Director of Product Management, Sparta Systems

Increased competition, regulatory scrutiny and tightening margins have changed expectations for quality teams drastically over the last several years. While compliance remains the top focus, a recent report indicates that new objectives around performance improvement and operational efficiency are gaining ground. Here we take a deeper dive into each of the three key quality objectives for 2018 to understand the obstacles quality teams face and how to overcome them.  

Maintaining Compliance

Quality teams must demonstrate and document the quality of their company’s processes and products.  So, it’s no surprise that 73 percent of quality lab3professionals view maintaining compliance as their top objective in 2018. When drugs are pulled from shelves or fail to launch in new markets, revenues take a beating. But maintaining compliance isn’t a simple matter. Requirements can vary from country to country and can change throughout a product’s lifecycle.

Additionally, limited headcount and limited budget were noted as the top two obstacles to meeting quality objectives in 2018. Thus, it is easy to see how not having the budget and headcount to properly manage compliance can make matters worse. 

Improving Economic Performance

According to the report, economic performance-focused objectives were nearly as critical for quality teams this year, at 40 percent of respondents. Reducing department costs was not far behind, at 35 percent. This is likely because performance efficiency positively impacts revenue — typically a top objective for senior executives. By improving performance and cutting unnecessary costs, quality teams can certainly expect to see increased investments budget and hiring, but there is a catch: Many teams lack the data needed to benchmark and improve upon performance.    

In fact, nearly one-third of respondents from the report saw data analysis and reporting capabilities as a major obstacle to meeting 2018 quality objectives. 

Impacting Manufacturing Performance

Overall, economic performance was not the only factor quality professionals were looking to improve on, as 35 percent said they would be working to enhance manufacturing performance. This indicates that they have put critical initiatives such as improving product quality and reducing manufacturing costs at the top of their priority list. It also appears that leading quality teams have a plan in place, as nearly half anticipated that they would be using quality data in the next 12-16 months to accomplish this objective.

This is the right course of action, as data-driven decision-making drives how pharmaceutical companies and quality departments operate. In today’s digital age, quality professionals must have access to quality data in order to improve their organization’s manufacturing performance and processes.

Meeting Objectives in 2018 and Beyond

To truly contribute to the success of their organizations, quality teams must go beyond compliance and help to impact company-wide performance — improving product quality, reducing manufacturing costs and increasing margins.

To meet these new demands and enable lasting change, companies must invest in their quality teams and provide them the enablement tools that can truly streamlines processes. By investing in a technology enablement platform, quality teams can better capture and measure performance within the quality department as well as cross-functionally where other departments touch quality and achieve their objectives. 

Brandon Henning is the Director of Product Management at Sparta Systems.

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