Featured Video
This Week in Quality Digest Live
FDA Compliance Features
Grant Ramaley
The quiet battle over medical device trade in Canada heats up
Richard Pazdur
Regulatory work must keep pace with emerging cancer therapies
Mike Richman
Understanding cultural issues that help or hurt organizational performance
Scott Gottlieb
Embracing change may mean a regulatory paradigm shift for the FDA
Vanessa Burrows
How a public exhibit led to the 1938 Food, Drug, and Cosmetic Act

More Features

FDA Compliance News
An invite from Alcon Laboratories
Intended to harmonize domestic and international requirements
The FDA wants medical device manufactures to succeed, new technologies in supply chain managment
Pharma quality teams will have performance-oriented objectives as well as regulatory compliance goals
Strategic investment positions EtQ to accelerate innovation efforts and growth strategy
The FDA’s RMAT designation goes live
Awards help states implement multiyear produce-safety systems
The future of medical product development?

More News

Sparta Systems Inc.

FDA Compliance

Pharma Companies Expect Role of Quality Management Teams to Evolve in 2018

Pharma quality teams will have performance-oriented objectives as well as regulatory compliance goals

Published: Wednesday, January 31, 2018 - 16:10

(Sparta Systems: Hamilton, NJ) -- A recent survey sponsored by Sparta Systems and conducted by Pharmaceutical Technology, found that while compliance remains the top objective in 2018 among 73 percent of pharmaceutical executives, performance-oriented objectives were nearly as critical for the year ahead.

The findings of the survey are discussed in the report, “2018 Pharma Quality Outlook: The New Role of Quality Teams.” The research 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,” says 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” during the next 12 to 16 months. 

To access a full copy of the report, click here.

Discuss

About The Author

Sparta Systems Inc.’s picture

Sparta Systems Inc.

Founded in 1994, Sparta Systems Inc. is the leading provider of enterprise quality management software. In addition to its U.S. operations, the company provides sales and services to Europe, Asia, and Australia through its subsidiary, Sparta Systems Europe Ltd.

Visit www.spartasystems.com.