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Medical Device Suite, powered by InSite by Camstar Systems Inc. :: Last updated on September 21, 2006

Camstar's Medical Device Suite is a best-in-class, enterprise Manufacturing Execution and Quality Management System created specifically for Medical Device Manufacturers. It provides a manufacturing quality and compliance framework that facilitates global manufacturing excellence, resulting in continuous process improvement, higher yields, efficient product rollout, reduced regulatory risks, and lower cost of compliance.

Supporting Titles 21 CFR Part 11 and 820 compliance, Medical Device Suite provides the manufacturing control needed to help eliminate scrap, rework, paperwork errors and redundant checks; and the real-time feedback needed to quickly identify and resolve issues that inhibit process and product improvement.

Key Features

• Order Tracking
• WIP Tracking, including multi-level tracking
• Unit/Lot/Batch Serialization
• Workflow movement trace
• Lot Splits/Combines
• Labor Tracking
• Resource Tracking
• Logistic and Parametric Data Collection
• Automated Data Collection
• Material Consumption and Removal
• Quality Management
• Material Hold/Releases
• Process Enforcement - Materials, Route, Instructions
• Manufacturing Calendar and Reporting
• Manufacturing Audit Trail
• Complete production activity trace
• Complete resource activity trace
• Process Model Management
• Product Data Definition
• Revision Control
• Physical Model Management

Contact Information

Medical Device Suite, powered by InSite  Resource Center

WHITE PAPERS CASE STUDIES WEBCASTS VIDEO/PODCASTS RESEARCH E-BROCHURE   Making Life Sciences from Life This paper explores how Biotechnology manufacturers can reduce variability and costs, while increasing yields and quality. What is the Essence of Quality, Beyond CAPA? This paper examines and makes the case for going beyond traditional Quality Management systems (CAPA, Complaint Handling, Audit etc) to the essence of quality; fundamental understanding and control of manufacturing processes. Design for Manufacturability: Building Quality by Design Medical Device manufacturers are facing some of the most difficult challenges ever encountered by the industry. As competition intensifies, they must innovate and capitalize on new opportunities and expedite time to market. Enabling Operational Excellence with Performance Management This white paper explains how Medical Device organizations can leverage and extend their SAP applications into Manufacturing. Risk Management: Best Practices for Medical Device Profitability This research study from industry analyst firm Cambashi assesses the extent to which risk management is routinely employed within medical device companies as part of day-to-day development, procurement and manufacturing operations. It also identifies weaknesses in current approaches and identifies best practices. Six Keys to Profitable Growth in Solar Cells & Production Software’s Role This white paper identifies the challenges that Solar Cell manufacturers must face to create a foundation for sustainable, profitable growth. Enabling Operational Excellence with Performance Management This white paper explains how Medical Device organizations can leverage and extend their SAP applications into Manufacturing. Risk Management: Best Practices for Medical Device Profitability This research study from industry analyst firm Cambashi assesses the extent to which risk management is routinely employed within medical device companies as part of day-to-day development, procurement and manufacturing operations. It also identifies weaknesses in current approaches and identifies best practices. Six Keys to Profitable Growth in Solar Cells & Production Software’s Role This white paper identifies the challenges that Solar Cell manufacturers must face to create a foundation for sustainable, profitable growth. Enabling Operational Excellence with Performance Management This white paper explains how Medical Device organizations can leverage and extend their SAP applications into Manufacturing. Risk Management: Best Practices for Medical Device Profitability This research study from industry analyst firm Cambashi assesses the extent to which risk management is routinely employed within medical device companies as part of day-to-day development, procurement and manufacturing operations. It also identifies weaknesses in current approaches and identifies best practices. Metrics for Major Initiatives Practices and Metrics for Lean, Total Quality, and Real Time Enterprise Programs Six Keys to Profitable Growth in Solar Cells & Production Software’s Role This white paper identifies the challenges that Solar Cell manufacturers must face to create a foundation for sustainable, profitable growth. Sony Ericsson High Tech Customer Success Story High Quality, High Volume, Mission Critical Manufacturing Renesas Technology Corp. Hi-Tech Customer Success Story Standardized, Streamlined, Global Semiconductor Manufacturing Sony Ericsson High Tech Customer Success Story High Quality, High Volume, Mission Critical Manufacturing...Read this Case Study to find out about it! No webcasts available for Medical Device Suite, powered by InSite at this time. Please view more related resources from Camstar Systems Inc. Innovative Strategies to Integrate Development, Manufacturing and Commercialization of Customized Medical Devices The integration of PLM solutions with MES promises to tie the product development process to the physical world of production which will dramatically improve both product innovation and design for manufacturability, especially for manufacturers of highly complex products. Learn more in this informative webcast. Innovative Strategies to Integrate Development, Manufacturing and Commercialization of Customized Medical Devices The integration of PLM solutions with MES promises to tie the product development process to the physical world of production which will dramatically improve both product innovation and design for manufacturability, especially for manufacturers of highly complex products. Learn more in this informative webcast. Do you “Test in Quality” or Practice “Quality by Design”? : Enabling Product Quality by Design through Engineering and Manufacturing Collaboration This webcast will describe new processes and technology that will help medical device manufacturers to innovate continuously by developing a quality by design environment. Next Generation Quality Management - from Reactive to Proactive In this webcast, Simon Jacobson, Research Analyst, AMR Research and Karim Lokas, Vice President, Product Strategy, Camstar Systems, Inc. will discuss how manufacturers can and leverage a Networked Quality Management approach to achieve proactive "Quality Execution". Enabling Operational Excellence through Seamless Visibility and Control with Camstar and SAP This webinar will discuss how you can easily extend your SAP applications into manufacturing with Camstar's packaged composite solution, built specifically for Medical Device manufacturers, leveraging SAP MII and Camstar's Enterprise Manufacturing and Quality Platform. Do you “Test in Quality” or Practice “Quality by Design”? : Enabling Product Quality by Design through Engineering and Manufacturing Collaboration This webcast will describe new processes and technology that will help medical device manufacturers to innovate continuously by developing a quality by design environment. Reducing Risk with State-of-the-Art MES Semiconductor and electronics companies were pioneers in adopting Manufacturing Execution Systems (MES). MES is nearly ubiquitous in both fabs and back-end facilities as well as many electronics plants. These operations need plant-wide information in near real-time. MES to Regain Control in Outsourced Operations Outsourcing is a way of life in electronics, from fabless semiconductor companies working with foundries and assembly and test providers to board, box and system OEMs who work with Electronics Manufacturing Services (EMS) or other contractor partners. The industry structure allows each company to specialize and reduce their expensive capital asset base. However, outsourcers have also chosen, by intent or not, to take on other issues and additional risk as a result of ceding control of their operations. Winning Profit in the Age of Continuous Innovation Camstar defines Closed Loop Quality Execution, the next leap forward for Manufacturing, in this informative e-book. Winning Profit in the Age of Continuous Innovation Camstar defines Closed Loop Quality Execution, the next leap forward for Manufacturing, in this informative e-book. Winning Profit in the Age of Continuous Innovation Camstar defines Closed Loop Quality Execution, the next leap forward for Manufacturing, in this informative e-book. Winning Profit in the Age of Continuous Innovation Camstar defines Closed Loop Quality Execution, the next leap forward for Manufacturing, in this informative e-book.

Core Capabilities

• Manufacturing
• Batch Process Reporting
• Kitting & Kit Processing
• Labor Reporting
• Lean Manufacturing
• Lot & Serial Reporting
• Materials Management
• Plant Floor Data Collection
• Production Order Management
• Production Reporting
• Production Scheduling
• Manufacturing Execution Systems (MES)
• Manufacturing Process Management
• Operations Performance Management
• Operator Interface
• Process Control
• Quality Management
• Supervisory Control
• Product Lifecycle Management (PLM)
• Engineering
• Product Data Management
• Product Information Management
• Quality Management
• Cost of Quality
• Inspection and Testing
• Laboratory Information Management
• Nonconformance and Corrective Action
• Product Handling and Servicing
• Quality Documentation
• Quality System Interfaces
• Statistical Analysis/Techniques

Industries

• Automotive Supplier
• Consumer Packaged Goods - House, Health, Beauty Products
• Electronics and Semiconductors
• Hi-Tech (Computers, Communications, Office)
• Instruments and Controls
• Medical Devices
• Metals - Fabrication and Assembly
• Miscellaneous Manufacturing

Platforms

• Microsoft Windows Server 2003
• Sun Solaris/Sun OS

Databases supported

• IBM DB2
• Microsoft SQL Server
• Oracle

Target Business Size(s)

• Large (501+ users)
• Mid-Size (101-500 users)
• Small (1-100 users)

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