Tampa, FL—Feb. 1, 2016—Pilgrim Quality Solutions, a leading global provider of enterprise quality management software and services for the Life Sciences, today announced the latest release of SmartSolve® Complaint Management. Enhancements made to the solution demonstrate Pilgrim’s ongoing commitment to helping its customers achieve regulatory compliance by incorporating the latest FDA specifications for electronic Medical Device Reporting (eMDR).
As of August 14, 2015, FDA mandates now obligate all medical device reports be submitted electronically in a specific format to the Center for Device and Radiologic Health (CDRH) through the FDA’s electronic gateway. Since then, several FDA modifications have been introduced that change the content and structure of those electronic reports. Pilgrim’s release of Complaint Management prepares manufactures and importers for compliance with these latest eMDR reporting regulations.
“Keeping our clients compliant with changes in FDA regulations is an important commitment we’ve made to them and it’s one we take very seriously,” said Kari Miller, Pilgrim’s Vice President of Regulatory and Product Management. “The timeliness of this latest release of SmartSolve Complaint Management demonstrates Pilgrim’s commitment to and regard for evolving regulatory requirements. Furthermore, it gives our customers the tools they need to meet their FDA reporting obligations with respect to issues of patient safety and public health.”
Pilgrim continues to update its complaint management software to support changes to those regulatory requirements that impact its customers. In 2015, Complaint Management updates included capture for unique device identifier (UDI) numbers and alternative summary reporting (ASR).
The solution’s updated software also improves customers’ ability to successfully pass FDA audits with a robust database that allows for the tracking and trending of complaint data.
Complaint Management is an integrated part of SmartSolve, Pilgrim’s quality management suite of solutions. Integration across the platform ensures that product complaints are addressed using a consistent and compliant workflow. Additionally, Complaint Management facilitates compliance with IT security standards and regulatory requirements, including FDA 21 CFR Parts 820 and 803.
About Pilgrim Quality Solutions Pilgrim Quality Solutions is a leading global provider of enterprise quality management software and services for the Life Sciences and other highly regulated industries. For more than 20 years, our solutions have automated thousands of processes that ensure the quality of life’s most important products. Product quality and patient safety increase while risks decline. Our on-premise and cloud technologies reflect quality industry standards and include electronic signatures, audit trails and validation packs — helping customers more easily achieve compliance and pass regulatory audits. With Pilgrim Quality Solutions as your partner, you are prepared to succeed. For more information, visit www.pilgrimquality.com.