Software helps resolve customer complaints.
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Press Release Summary:
Complaint Handling(TM) module, part of Datasweep® Advantage(TM) suite, provides closed-loop, disciplined process for identifying, tracking, escalating, and analyzing product-oriented customer complaints while enabling conversion of complaints to corrective actions for rapid resolution. It allows management of real-time alerts and issues, giving manufacturers ability to visualize events as they occur, see trends over time, and proactively address potential events before they occur.
Original Press Release:
Datasweep Announces New Complaint Handling Solution for Life Sciences Manufacturers
Solution Extends Datasweep's Strength in Improving Operational Performance with a Structured Approach to Controlling and Resolving Product-oriented Customer Complaints
SAN JOSE, Calif.-June 4, 2003-Datasweep, Inc., the leader in operations performance management solutions for manufacturers, today announced the Datasweep Complaint Handling(TM) solution, a new and integrated module within the Datasweep® Advantage(TM) suite that provides a closed-loop, disciplined process for identifying, tracking, escalating and analyzing product-oriented
customer complaints, while enabling the conversion of complaints to corrective actions for rapid resolution. The Datasweep Complaint Handling module provides a critical link between
call center complaints and the product lifecycle to quickly trace and resolve product issues. As with all Datasweep applications, the Complaint Handling module is fully integrated with the Datasweep Dashboard(TM) to allow advanced management of real-time alerts and issues, giving manufacturers the ability to visualize events as they occur, see trends over time and proactively address potential events before they occur. The new module helps medical device manufacturers streamline operational performance and improve customer satisfaction while reducing costs and exposure to potential recalls or compliancy audits.
"Complaints can cost a manufacturer millions of dollars in quality and compliancy penalties," said Greg Gorbach, director of Collaborative Manufacturing Research at ARC Advisory Group.
"Manufacturers that adopt a complaint handling approach across the entire product lifecycle can successfully address a much broader set of issues including audit compliance, design changes,
corrective actions, supplier management, and the ability to achieve continuous and predictable quality at lowest cost. Datasweep's Complaint Handling module addresses this need."
The Complaint Handling module is designed to help manufacturers control the complaint management process so that they can successfully expedite the resolution of major issues, reduce
time spent on issue management, reduce risk of FDA and QSR non-compliance, and facilitate rapid, accurate responses to customers on all product issues. The Datasweep Complaint Handling
module is an integrated part of the Datasweep Advantage suite, enabling full part and product traceability, seamless connection with corrective and preventive actions (the Datasweep CAPA(TM)
solution), and full integration with the Datasweep RMA Management and Repair(TM) applications to automatically track and analyze the progress of failed or defective products. Datasweep's global data management and analytics help manufacturers identify trends, perform root-cause and failure
analysis, and measure and monitor resolutions so that complaints can be identified and managed across multi-site operations and the extended supply chain.
"Managing customer-focused quality is the number one concern of manufacturers in regulated markets," said Vladimir Preysman, president and CEO of Datasweep. "Medical device manufacturers face severe penalties and risks if they don't have a reliable system in place to solve, track and prevent quality problems in the field. Datasweep delivers integrated operations performance management solutions, including the new Complaint Handling module, to help manufacturers achieve continuous quality, improved yield, efficient processes and regulatory compliance."
The Complaint Handling module provides auto-generation of information for the FDA and the European Vigilance reporting systems. It offers user-defined decision trees to facilitate the
appropriate identification and resolution path for complaints, ensuring appropriate corrective actions and regulatory reporting. Datasweep's dynamic and flexible workflow enables
collaboration as well as configurable alerting notifications. Built-in business rules permit secondary signoff and escalation capabilities for categorization and deadlines. As in all Datasweep products, the Complaint Handling module is 21 CFR Part 11 compliant with full audit logs and built-in security rules.
About Datasweep
Datasweep is the leader in operations performance management solutions for manufacturers. Datasweep solutions uniquely enable global manufacturers to collect, aggregate, analyze and act
on product and operational data from the entire product lifecycle and supply chain, improving process efficiencies and product quality, reducing product lifecycle costs and ensuring regulatoryDatasweep Announces Complaint Handling Solution for compliance. Datasweep customers are achieving fast time-to-benefit and lower cost of ownership, deploying in as few as eight weeks. Headquartered in San Jose, California, Datasweep serves customers in high-tech, life sciences, automotive, telecommunications and other industries, including Flextronics International, Ltd. (FLEX), General Electric (GE), Harris Corporation (HRS), Johnson & Johnson (JNJ), KLA-Tencor Corporation (KLAC), Lucent (LU), Plexus (PLXS), Sanmina-SCI (SANM), Siemens Medical Group USA, Inc. (SI), SonoSite (SONO) and
St. Jude Medical (SJM). Additional information can be found on the Internet at www.datasweep.com.
Datasweep is a registered trademark of Datasweep, Inc. Advantage, Complaint Handling, CAPA, Dashboard, and RMA Management and Repair are trademarks of Datasweep, Inc. All other trademarks are the property of their respective owners.
