Software includes corrective and preventive action.
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Press Release Summary:
Datasweep® CAPA(TM) helps manufacturers analyze data, view trends, apply resolutions and monitor effectiveness in real-time across all incidents to ensure regulatory compliance and continuous quality improvement. It gathers and provides detailed information across entire manufacturing and service cycle, enabling root-cause analysis based on device history records, maintenance, and test records. CAPA ensures compliance to ISO 9000 and FDA GMP regulations.
Original Press Release:
Datasweep Delivers Next-Generation CAPA Solution
New Application Includes Corrective and Preventive Action, Incident Management and Business Intelligence to Create Closed Loop Process for Predictable Quality
SAN JOSE, Calif.-December 10, 2002-Datasweep, Inc., the leader in operations performance management solutions for manufacturers, today announced the availability of the Datasweep® CAPA(TM) solution, a new application available as part of the web-based Datasweep Advantage(TM) Suite. The Datasweep CAPA solution provides global manufacturers a top-down, process-oriented approach to improving enterprise-wide quality by formalizing and optimizing the corrective and preventive action process.
Datasweep's workflow-based solution helps manufacturers in life sciences and other industries analyze data, view trends, apply resolutions and monitor effectiveness in real-time across all incidents to ensure regulatory compliance and continuous quality improvement. The Datasweep CAPA solution helps manufacturers deliver higher customer satisfaction through increased product quality, improved collaboration and reduced costs.
"The FDA has reported that the lack of effective CAPA management is the number one cause for citations issued today, making quality assurance solutions a key focus for manufacturers in regulated industries," said Vladimir Preysman, CEO of Datasweep. "Datasweep's new workflow-driven CAPA solution is designed to build and maintain business processes that will ensure predictable and sustainable quality to manufacturers in all industries."
According to an AMR Research Alert, "Companies are now required to have a comprehensive integrated quality management strategy in place that encompasses the maze of quality management islands across all areas of manufacturing operations." CAPA: A Platform for Top-Down Quality Management, AMR Research, April 2002.
Datasweep's CAPA solution consolidates various systems including supplier, non-conformance, complaint and audit applications and databases, which provides manufacturers with a global, centralized view to improve and control business processes. Corrective actions can be prioritized and correlated, and the effectiveness of a corrective action can be easily determined within the Datasweep CAPA solution. Datasweep provides incident management within the CAPA application to track, manage and trend deviations, discrepancies and exceptions through comprehensive data collection, workflows, alert monitoring and analysis.
Datasweep's ability to gather and provide detailed information across the entire manufacturing and service cycle enables root-cause analysis based on device history records, maintenance and test records. Full data access also ensures effective revision control and a comprehensive audit trail of all transactions, signatures, security and alerts. The Datasweep CAPA solution enforces business processes ensuring compliance to ISO 9000 and FDA GMP regulations, including 21 CFR Part 11 and 820 guidelines.
CAPA Module Features
Datasweep's CAPA solution offers new features including:
o Configurable workflow to design and enforce business rules and management processes
o Integrated incident tracking
o Supplier corrective actions, enabling collaborative CAPA with suppliers
o Integrated business intelligence for root-cause analysis, trending and reporting
o Roles-based authorizations, security and electronic signatures
o Web-based dashboard, portal, alerts and triggers that can be configured to user preferences
o Key metrics to measure CAPA cycle times, effectiveness, and activity
o Audit capability to measure effectiveness after completion of CAPA action
o Seamless integration to manufacturing, supplier and service systems, including engineering change order (ECO) execution and management
About Datasweep
Datasweep, the leader in operations performance management solutions for manufacturers, develops and markets web-based solutions incorporating manufacturing execution, quality assurance, repair and business intelligence applications. Global manufacturers and their supply chain partners use Datasweep Advantage software to leverage the Internet to improve delivery and quality while reducing cost and inventory throughout the product lifecycle. Customers include General Electric (GE), Johnson & Johnson (JNJ), Lucent (LU), Flextronics International, Ltd. (FLEX), KLA-Tencor Corporation (KLAC), Harris Corporation (HRS), Finisar (FNSR) and SonoSite (SONO). Additional information can be found on the Internet at www.datasweep.com.
Datasweep is a registered trademark of Datasweep, Inc. Advantage and CAPA are trademarks of Datasweep, Inc. All other trademarks are the property of their respective owners.
