Pilgrim Updates its Complaint Management Software Solution for Medical Device Companies

Pilgrim Quality Solutions, a provider of enterprise quality management software and services for the life-sciences industries, has released an updated version of its Complaint Management system. Complaint Management is an integrated part of SmartSolve, Pilgrim’s quality management suite of solutions.

According to officials with the Tampa, Fla.-based firm, the enhanced solution includes features that allow companies to more readily capture medical device and combination product identification data for adverse events and to support mandatory data reporting to the appropriate global regulatory bodies.
When Pilgrim introduced Complaint Management in 2013, it was, according to the company, the industry’s “first solution to feature built-in regulatory guidance to facilitate efficient, accurate and consistent global adverse event reporting.”

In September 2014, the global Unique Device Identifier (UDI) regulation went into effect for class III medical devices and combination products, and Pilgrim’s Complaint Management now captures those products’ UDI number for tracking complaint records and for downstream adverse event reports. By recording product UDI data, defective devices can be accurately identified and isolated more easily allowing for faster complaint handling or recall management.

Today’s newly enhanced solution also supports the U.S. Food and Drug Administration (FDA) Alternative Summary Reporting (ASR) program, which exempts certain types of devices with well-known problems from individual adverse event reporting requirements. The FDA initiated the program after determining that the submission of quarterly summary reports for recurrent adverse events related to certain devices and their well-known issues would sufficiently allow for effective monitoring and evaluation. Pilgrim’s solution now automatically produces the ASR and populates appropriate problem and conclusion codes into quarterly reports on those exempt devices with known failures, eliminating the time it would take to manually gather quarterly report data.

“UDI was instituted as a consistent and standard way to identify medical devices throughout their distribution and use, making adverse event reporting more accurate and specific, while the ASR program minimizes paperwork and reduces costs for both FDA and participating manufacturers, and affords manufacturers more time to follow up on adverse events,” said Thierry Durand, Pilgrim’s president and CEO. “With the addition of these two capabilities, Pilgrim’s enhanced Complaint Management solution enables users to comply with
these recent FDA guidances and improve the efficacy of their adverse event processes.”

Complaint Management also helps device manufacturers maintain compliance with electronic reporting requirements for the FDA’s MedWatch 3500A electronic device medical record file and the European Union’s electronic reporting format for eMedDEV.