Consider enterprise quality management systems for GDP tasks


The growing compliance requirements for distribution call for a streamlined approach

The category of enterprise quality management software (EQMS) has been around for quite a while, and managers in clinical trials, plant manufacturing and laboratories have been accustomed to employing these systems to collect data, organize it, and manage documents. A more recent applications is now coming on strong, says Matt Lowe, EVP at MasterControl (Salt Lake City, UT), one of the leaders in this space: good distribution practices (GDPs), especially as the recently enacted European Union GDP standards propagate through the global pharma industry.

“Quality systems are traditionally managed within each functional area of an enterprise—clinical, manufacturing, and so forth,” he says. “Distribution management is fairly new to this activity, and the advantages of an enterprise system are not well understood.” The company has done two things to broaden its platform’s appeal: a just-announced new user interface that improves interaction with the software; and, in the past year, a scaled-down version of the software called Spark, specifically for small businesses or dedicated functions within an enterprise.

EQMS systems serve to provide a centralized process to collect necessary documents, signatures and data to verify that a quality process has been maintained; a key function, often poorly managed, is documenting corrective actions. Lowe says that the bigger, global logistics companies serving the pharma industry have been using EQMS systems for a while now, but GDP standards are broadening their appeal.

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