Automating Quality Assurance

Siemens Medical taps Datasweep for corrective and preventive action solution

San Jose, CA  December 18, 2002  Siemens Medical Solutions is set to implement an operations performance management solution from Datasweep in an effort to achieve its goal of continuous quality improvement.

The Siemens division, dually headquartered in Malvern, Pa., and Erlangen, Germany, is one of the largest suppliers to the global healthcare industry, with 31,000 employees worldwide and preliminary fiscal 2002 sales of about $7.8 billion. The company is a global leader in oncology equipment for radiation therapy.

Siemens Medical selected Datasweep's Web-based corrective and preventive action (CAPA) system to improve overall corrective actions and risk management. Siemens will use Datasweep to ensure timely closure of CAPA actions and improve root-cause and failure analysis response times, while assuring quality, security and FDA 21 CFR Part 11 compliance for electronic signatures.

Datasweep said its Web-based CAPA solution, a new application in Datasweep's enterprise quality assurance product portfolio, offers corrective and preventive action, incident management and business intelligence to create a closed-loop process for predictable quality.

"We needed a solution for quality that was quick to implement, yet would provide the depth of functionality we required to meet our business needs," said John Ragazzo, vice president of quality management and regulatory affairs at Siemens Medical. "Datasweep's closed-loop CAPA solution easily models our business processes and provides powerful analytics that enable us to continuously monitor, analyze and improve our processes and quality levels."

Siemens will use Datasweep's CAPA solution to automate and improve manual processes across its manufacturing operations. Documents related to corrective actions, training records, audit trails, customer complaints, product design and quality records will be digitized, integrated and accessible within the Datasweep system. Siemens will be able to respond to audits on historical CAPA information and revisions through the system.

With the Datasweep solution, electronic notifications are automatically sent, helping to ensure corrective actions are performed and closed within the required time period. All actions taken, along with time and user stamps, are recorded and available for trend and performance analysis, along with compliance tracking.

Siemens is counting on these defect-tracking, closure-adherence and analysis tools to allow it to perform root-cause failure analysis and resolution in real time and to continuously improve its quality management system.