GxP Lifeline Feature Article

Study: Regulated Manufacturers Using Technology-Based Approach
to Compliance Gain Competitive Advantage

 

How Successful Regulated Manufacturers Approach Compliance

A recent survey of more than 340 regulated manufacturers throughout the world shows that those adopting an integrated, technology-based approach to compliance and traceability are 65 percent more likely to achieve “Best in Class” status and attain a competitive advantage.

The study titled “Compliance and Traceability in Regulated Industries: Benchmark Report” was conducted by the Aberdeen Group, a leading provider of fact-based research and market intelligence, and co-sponsored by MasterControl Inc. The Aberdeen Group surveyed manufacturers in pharmaceutical, medical device, food and beverage, chemical, aerospace, automotive, and other industries. Survey participants included Pfizer, Roche, and Wyeth.

The study, released in January, found that compliance and traceability needs of manufacturers stem from FDA and EU regulations (86 percent for best-in-class manufacturers, 72 percent for all others), and customer requirements, such as ISO standards (72 percent and 78 percent, respectively). Most regulated manufacturers still view traceability and compliance as a necessary business process. But at the same time, they utilize compliance and traceability as a competitive advantage (50 percent and 40 percent, respectively).

Survey results also show that:

  • 93 percent of manufacturers still relying on manual processes to manage compliance and traceability programs were unable to achieve “Best in Class” status.

  • 73 percent of best-in-class regulated manufacturers have integrated their compliance and traceability solutions with other enterprise applications.

  • Best-in-class companies are five times as likely to measure performance in real time than other manufacturers.

Recommendations for Action

Among others, the study recommended the following:

  • Utilize technology solutions to achieve automated traceability or real-time visibility into production processes.

  • Utilize operational metrics to measure the success of compliance and traceability programs.

  • Best practices should be implemented to achieve a competitive advantage, align mature quality programs, integrate document and process management, and institute a root-cause, closed-loop CAPA.

Read the study in its entirety:

White Paper:
Compliance and Traceability in Regulated Industries Benchmark Report




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