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CAPA/Remediation     Browse by:   Featured: Insights Audit Management Tools - Food Safety Audits and Inspections As the Federal and State officials are looking at fundamental issues related to food safety in radically different ways, companies are hiring an army of private auditors to monitor the food plants. Next-generation Audit Management tools for managing quality, compliance and risk programs can help companies address these issues and enable them to protect their brands and build trust with customers on a sustained basis.. Insights Alarming Rise in Automotive Safety Issues Quality issues in automobiles can not only result in commercial implications for the manufacturer, they also become life-threatening for customers and can severely damage reputation of the automotive company. In order to manage such crises, automakers need to comply with the Transportation Recall Enhancement Accountability and Documentation (TREAD) Act and diagnose the impairment, thus nullifying further recurrence of the impairment..   Demos   White Papers   RFP Templates   Insights   Webinar   Datasheets   Case Studies   Solution Briefs

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Demos Customer Quality Management and Complaints Management Solution Demo A comprehensive quality management solution for managing quality programs for streamlining quality processes involving customer and channel partners. Food Safety and Quality Management Solution Demo Solution to enable companies in the food and beverage industry to capture, route, correct, prevent, and analyze system-wide issues between their organization and their trading partners giving companies the ability to collaborate with their partners, provides a real-time view into quality data, and enables issue-tracking for a closed-loop compliance process. ISO 9000 Compliance Solution Demo Solution to automate quality management processes, gain real-time visibility into their quality metrics, reduce the costs arising out of poor quality, and comply with the ISO 9000 standard. Issue Management System Demo Comprehensive solution that enables companies to establish and follow consistent procedures for issue capture, loss event tracking, task management, and status reporting. Nonconformance and Corrective/Preventive Action (CAPA) Solution Demo Comprehensive non-conformance and CAPA software solution that enables companies to streamline identification, evaluation, segregation and disposition of nonconforming material as well as case investigation and tracking, leading to the CAPA process. Quality Management Solution for FDA Compliance Demo Integrated solution to meet FDA GXP regulations through risk management, document control, compliance training, ongoing auditing, as well as recording and reporting of exception events and the resulting corrective actions. Quality Management System for High Tech Manufacturing Demo Solutions to enable companies to gain real-time visibility into their quality metrics, reduce the costs arising out of poor quality, and comply with industry standards such as ISO 9000. Safety and Quality Management Solutions for Airlines Demo An integrated solution for successfully meeting the increasing regulatory and reporting requirements from the FAA and enable new levels of productivity, regulatory compliance, reduced costs and effective quality, safety and risk management. Six Sigma Management Solution Demo A comprehensive software solution for an effective Six Sigma program management within an organization by streamlining the processes and activities for the DMAIC and DMADV methodologies. Supplier Quality Management Solution Demo A comprehensive quality management solution for managing quality programs for streamlining quality processes involving suppliers and vendors. Top

White Papers Quality assurance and regulatory compliance across the extended enterprise Achieving enterprise-wide quality requires the collection of key metrics from disparate and disconnected sources in the enterprise.This could come from production, quality assurance,engineering, customer service and purchasing departments. This paper discusses why it is essential for organizations to have a web-based system to help them integrate, automate and provide visibility into these metrics from across the enterprise. Enterprise Quality Management: Automotive issues and perspectives Compliance to different quality system requirements, the complex nature of requirements and multiplicity of specifications placed a significant burden on automotive suppliers, adding to their cost of compliance. This paper discusses the evolution of the regulatory framework for the automotive industry, the recent regulatory challenges and a cost efficient way to address these requirements. An Overview of cGMP Policies for Quality Management Over the last 25 years there have been fewer FDA inspections and significant changes in government regulations and drug manufacturing processes. With technological advances in pharmaceutical sciences and manufacturing technologies, a risk-based approach to regulation and efforts towards global harmonization, the new regulatory initiatives for FDA compliance will impact greatly. Corrective and Preventive Actions Implementing a Corrective and Preventive Action (CAPA) system can help overcome operational risks by realigning data and obviating errors but it will go only to the extent to which it has been integrated with the rest of the support systems and policies of the hospital. This white paper gives a clear understanding of the challenges being faced by the healthcare providers today, how CAPA processes and systems can provide a solution and the features that a best-in-class CAPA solution must provide. Quality and compliance in USDA regulated industries In order to compete in today's global marketplace, food manufacturers and food service operators need to increase their productivity and ensure enterprise-wide quality and compliance. The most effective way to accomplish these objectives is by incorporating the principles of quality and compliance management into the overall corporate strategy. This paper discusses the various challenges in this industry and how an IT system can play a vital role in achieving the corporate goals for quality. Greening Supply Chain The worlds best scientists have been warning - that climate change is happening faster and will bring bigger changes quicker than anticipated. Ironically market and the nature hitting the wall at once, is a sign that we need to find better ways to be more sustainable. Whether the drive is to comply with the government regulations or to meet the customers? expectations companies are finding motivation to go green. Quality management for multisite manufacturing The hi-tech industry is the motor for economic growth worldwide, setting a scorching pace in developing, producing, and marketing its hi-tech quality products across the globe. This paper discusses the various quality standards pertaining to the hi-tech industry and why a Hi-tech enterprise plan requires an effective global quality management system to manage the entire spectrum of activities towards final delivery. Quality and compliance for the hi-tech industry The High Tech industry faces dynamic challenges with shrinking product life cycles, and demands for constant product innovation. This paper discusses the need for an enterprise-class quality management system to forge better understanding between customers and vendors across the extended enterprise while helping the enterprise reduce nonconformance issues and comply with regulations and standards. ISO 9000 - An Integrated Approach The primary focus of ISO 9000 is to develop a proactive approach to preventing defects or errors or deficiencies in manufacturing of products or provisioning of services. This paper discusses the relevance of ISO 9000 to a corporate strategy, the implementation strategy and the best practices to maximize the value. Quality and compliance in the medical device industry: issues and perspectives The strong emphasis on quality in medical device manufacturing imposes stringent demands on the design and validation processes, as well as the packaging and logistics aspects. Furthermore, this industry is strictly FDA-regulated, and regulatory certification and compliance monitoring are critical needs to establishing strong customer and market credibility. This paper lists the challenges faced today by medical device manufacturers and the possible solutions to the problems. Enterprise-wide CAPA management to help comply with FDA requirements FDA's Quality System Inspection Technique (QSIT) is the primary inspection program for the medical device industry. The FDA views CAPA as being directly linked to all of the other subsystems and the FDA code for CAPA defined by 21 CFR 820.100 requires strict control and management of these corrective and preventive actions. This paper discusses the importance of IT systems in implementing CAPA across the Enterprise for Medical Device manufacturers. Benefits of compliance and quality solutions for the food services industry Food quality and food safety are among the most critical concerns of all companies in the food supply chain, especially foodservice operators. Foodservice operators today must strive to meet food quality and safety demands arising from a host of sources including customers. This paper describes how MetricStream's holistic solution for quality management helps companies achieve their quality objectives at the enterprise level. Enhance quality tracking and process efficiency optimization in pharmaceutical manufacturing The pharmaceutical industry is among the most heavily regulated, both in the product development,clinical trial and manufacturing phases. The nature of this industry demands the highest standard of production precision and detailed product and process reviews. This paper discusses the advantages of implementing a robust software solution that can address the most complex process and quality requirements in a secure,easy-to-use and scaleable manner for the pharmaceutical companies. Quality and compliance in the Pharmaceutical industry: issues and perspectives The pharmaceutical industry is subject to a number of regulations stipulated by Food and Drug Administration (FDA) and other regulatory authorities. These regulations enforce strict quality standards on pharmaceutical companies to ensure the safety and benefits of the products made by them. This paper discusses the importance of IT systems in addressing the issues related to ensuring compliance to FDA regulations. Quality*Stream for Compliance and Quality Management Organizations are successfully implementing enterprise-wide quality and compliance systems to gain visibility and control over key quality processes across their operations and to ensure compliance with government regulations, industry mandates, company policies and internal initiatives. This paper discusses how the MetricStream system helps you to comply with industry mandates such as TS16949 or QS9000:2002 or implement internal initiatives such as ISO9000 or sixsigma. Top

RFP Templates Customer Quality Management and Complaints Management Solution RFP Template A comprehensive quality management solution for managing quality programs for streamlining quality processes involving customer and channel partners. Food Safety and Quality Management Solution RFP Template Solution to enable companies in the food and beverage industry to capture, route, correct, prevent, and analyze system-wide issues between their organization and their trading partners giving companies the ability to collaborate with their partners, provides a real-time view into quality data, and enables issue-tracking for a closed-loop compliance process. ISO 9000 Compliance Solution RFP Template Solution to automate quality management processes, gain real-time visibility into their quality metrics, reduce the costs arising out of poor quality, and comply with the ISO 9000 standard. Issue Management System RFP Template Comprehensive solution that enables companies to establish and follow consistent procedures for issue capture, loss event tracking, task management, and status reporting. Nonconformance and Corrective/Preventive Action (CAPA) Solution RFP Template Comprehensive non-conformance and CAPA software solution that enables companies to streamline identification, evaluation, segregation and disposition of nonconforming material as well as case investigation and tracking, leading to the CAPA process. Quality Management Solution for FDA Compliance RFP Template Integrated solution to meet FDA GXP regulations through risk management, document control, compliance training, ongoing auditing, as well as recording and reporting of exception events and the resulting corrective actions. Quality Management System for High Tech Manufacturing RFP Template Solutions to enable companies to gain real-time visibility into their quality metrics, reduce the costs arising out of poor quality, and comply with industry standards such as ISO 9000. Safety and Quality Management Solutions for Airlines RFP Template An integrated solution for successfully meeting the increasing regulatory and reporting requirements from the FAA and enable new levels of productivity, regulatory compliance, reduced costs and effective quality, safety and risk management. Six Sigma Management Solution RFP Template A comprehensive software solution for an effective Six Sigma program management within an organization by streamlining the processes and activities for the DMAIC and DMADV methodologies. Supplier Quality Management Solution RFP Template A comprehensive quality management solution for managing quality programs for streamlining quality processes involving suppliers and vendors. Top

Insights Audit Management Tools - Food Safety Audits and Inspections As the Federal and State officials are looking at fundamental issues related to food safety in radically different ways, companies are hiring an army of private auditors to monitor the food plants. Next-generation Audit Management tools for managing quality, compliance and risk programs can help companies address these issues and enable them to protect their brands and build trust with customers on a sustained basis. Alarming Rise in Automotive Safety Issues Quality issues in automobiles can not only result in commercial implications for the manufacturer, they also become life-threatening for customers and can severely damage reputation of the automotive company. In order to manage such crises, automakers need to comply with the Transportation Recall Enhancement Accountability and Documentation (TREAD) Act and diagnose the impairment, thus nullifying further recurrence of the impairment. Audit Performance Measurement While the Internal Audit function is gaining popularity as a guardian of good corporate governance and the leader of business performance, measuring the Internal Audit?s performance can play a critical role. Regulators and investors are demanding increased scrutiny of an organization?s operation, making the Chief Audit Executive?s (CAE) job more complex and challenging. Effective Governance through Internal Auditing Internal Audit supports the Board of Directors (BoD) and its committees by independently assessing the effectiveness of an organization?s system of internal controls as well as compliance with statutory, legal and regulatory requirements. Given the importance the BoD attaches to this role, organizations are making every effort to adopt Internal Audit across the enterprise for better management of risk and effective compliance with regulation. Integrated Supplier Audits for Better Supply Chain Governance Supply chain governance can help organizations streamline and manage their supplier quality and performance. Supplier audits and inspections is a critical process that supports quality and compliance management when dealing with vendors, suppliers and contract manufacturers. Site Inspections: Road Map to On-Time Supplier Quality Assurance Supplier quality issues like non-conformance management, product recalls and product failures are proving fatal for global organizations. World-class manufacturers are realizing the need to maintain a consistent and systematic quality process to gain real time inspections data with analytics of trend analysis. Audit Management in Retail and Grocery Operations Ongoing audits are critical to support quality processes, regulatory compliance and risk management throughout the product life cycle and along the supply chain for retail and grocery operations. Integrated Supplier Audits for Better Supply Chain Governance Supplier audits and inspections is a critical process that supports quality and compliance management when dealing with vendors, suppliers and contract manufacturers. World class organizations are looking to incorporate best practices in supplier audit management when implementing supply chain governance and performance management programs. Benefits Of A Supplier Quality System - A Case Study The manufacturer had built a network of about 25 core suppliers and sourced 90% of their components from them. In order to identify opportunities for improving supplier quality, the manufacturer started evaluating their key supplier-facing product quality and delivery quality processes. The manufacturer discovered a number of issues from the analysis. Best Practices In Supplier Quality Management Companies that sell industrial products need to preserve their preferred supplier status to continue to be considered for future business. As a result they are under pressure to ensure that their products continue to meet or exceed acceptable PPM and Corrective Action thresholds set by their customers. Can't Get Budget Approval For Your Quality Management System? Many quality directors have difficulty in getting capital budget approvals to acquire a badly needed Quality Management System (QMS). The reason in most situations is that their justification approaches the system benefits from a bottom-up operational perspective ?the new system will provide a mechanism to achieve key quality objectives such as issue tracking, developing and implementing corrective actions and reporting on the key process improvement metrics. Corrective Action (CAPA) Systems At Innovative Companies In a manufacturing organization, when Deviations, Nonconformance, Out of Specifications, Incidents or Complaints occur, Corrective and Preventive Actions need to be initiated to remedy the problem. Once a CAPA has been initiated, it follows its assigned workflow process. How To Build A Business Case For A Quality Management System The goal of the business case is to ensure that the project delivers value greater than the corporate hurdle rate for capital investments. This paper provides a proven step-by-step process to developing a business case for a Quality Management System (QMS) within an enterprise. How To Give A Quality Score To Your Supplier A supplier scorecard contains categories or main groupings of metrics by which suppliers are measured. These categories include quality, delivery, cost, and responsiveness. Aggregated score for each category is calculated first, providing a company visibility into quality score, delivery score, etc. Incorporating Quality Into Management Style - Gunjan Sinha, Chairman, Metricstream Inc. In progressive companies, managers are not merely focused on enhancing organizational output and productivity, but are also aware of achieving greater degree of compliance and quality to the regulatory frameworks of their industries, economies and communities. Managing Quality At Outsourced Manufacturing Operations The need for enterprise quality management is amplified for companies in the technology industry. These companies have increasingly shifted manufacturing and assembly operations offshore to low cost countries or have outsourced these functions to a contract manufacturer. Paper-based Quality System Is More Costly Than You Think Paper-based quality management systems are fairly common in mid-sized organizations. While such systems can successfully manage product and process quality, they significantly increase the risk of cGMP non-compliance at FDA-regulated organization. Quality In An Outsourced Economy Ensuring quality of the outsourced components and services is a challenge for most organizations. This article addresses the various practices companies have put in place to ensure the quality of product and service delivery from their outsourced partner. Quality System Requirements For Outsourced Manufacturing After outsourcing manufacturing to lower cost countries, many companies find new demands imposed on their quality management processes. As a result, many companies find their existing quality management systems to be no longer effective. This is especially true if their existing quality system is either paper-based or implemented using a PC-based point solution. Role Of Compliance And Quality In Managing Warranty Reserves And Costs Warranty costs, Returned merchandising Authorization (RMA) costs, mostly emerge due to Cost of Poor Quality (COPQ) of manufactured goods and services. Global quality initiatives help manufacturers to capture product and process defects sooner in the lifecycle, thereby eliminating the expensive costs associated with warranty returns and recalls. Safety In Airlines - Road To Safer Skies An SMS-based Risk Control Process is a way of systematically identifying the risks and then deciding whether to accept, reduce, or eliminate them as well as looking at the results of the decisions to ensure the intended results. While the SMS framework in based on the widely-adopted ISO standards for quality management, airlines are struggling to implement the framework successfully. Spreadsheet-Based Quality System Is More Costly Than You Think Spreadsheet-based quality management systems are fairly common in mid-sized organizations. While such systems can successfully manage product and process quality, they significantly increase the risk of cGMP non-compliance at FDA-regulated organization. Supplier Charge-backs Most manufacturers have implemented a Supplier charge-back program, where a supplier is charged for the additional cost incurred by a manufacturer due to non-conforming components, materials and late deliveries from suppliers. A charge-back system is an effective way to introduce business discipline and accountability into the supply chain. Supplier Quality Management This is the description for this document that explains the contents. This is the description for this document that explains the contents. This is the description for this document that explains the contents. This is the description for this document that explains the contents. This is the description for this document that explains the contents. This is the description for this document that explains the contents. Supplier Quality Management In Fda-regulated Industry To successfully leverage the global supply base of device parts, active ingredients, or inactive ingredients for staying competitive while maintaining product quality, pharmaceutical and medical device manufactures need to adopt a modern web-based quality management system that integrates the supplier quality with their internal quality process in a seamless manner. What Is Your Company's Cost Of Poor Quality (copq) - Tools For Calculating And Reducing It Experts have estimated that Cost of Poor Quality typically amounts to 5-30% of gross sales for manufacturing and service companies. Independent studies reveal that COPQ is costing companies millions of dollars each year and its reduction can transform marginally successful companies into profitable ones. Top

Webinar Best Practices in Supply Chain Governance and Performance Management This webinar covers the challenges companies face in managing global suppliers and contract manufacturers, and takes a look at how world class organizations are managing quality in their supplier network by using robust Supplier Quality Management systems. Optimizing Your Supply Chain Using Leaner Business Practices - Ensuring Greater Supplier Quality This webinar focuses on some of the key Supplier quality challenges, some techniques and best practices to identify product quality issues and resolve them by initiating a supplier corrective action request (SCAR) process, and minimize product liability and risks while improving the bottom line. Improve Supplier Quality and Mitigate Supply Chain Risks through Supplier Performance Management This complimentary webcast by MetricStream and AMR Research helps to understand how an effective supplier performance Management enables companies to use best practices such as supplier scorecards, KPIs, quality metrics and risk assessments and mitigation to improve quality and manage risk in the supply chain. Techniques to Address Supplier Quality Management Challenges in High Tech and Manufacturing industries This online webinar focuses on Streamlining Supplier Corrective Action Requests (SCAR) and supplier audits, integrating supplier quality data with supplier scorecards, implementing cost recovery and chargeback programs and integrating of supplier assessments with supplier risk and performance Management. Measuring Supplier Performance for Better Business Supplier performance measurement is critical for businesses dealing with multiple suppliers.This webinar covers some of the key aspects include Key Performance Indicators (KPIs), The three step supplier performance Management process, Supplier Contract Management and SLAs, Supplier Performance Scorecards and Key benefits of Supplier Performance Management. Extending the Scope of Operational Audits Join us for this webinar to see how several global Fortune 1000 companies have successfully upgraded from legacy audit systems, point-solutions and desktop tools to an integrated and flexible audit Management framework to manage audit processes across the enterprise. Enhance Your Supply Chain Governance and Improve Supplier Quality Management This complimentary webinar covers the challenges that companies face in managing global suppliers and contract manufacturers. We also take a look at how world class organizations are enhancing supply chain governance and performance Management programs to address critical areas like Supply Chain Risk and Controls, Supplier Quality Management, Vendor Audits and Inspections, Supplier Ethics and Compliance, and Supplier Collaboration. Effective and Efficient Audit Management for Quality Management System It is clear that the auditor?s job has grown in complexity. This leads to many opportunities for auditors to be value-added suppliers to the auditee organizations. In this webinar, Dr. Sandford Liebesman, Quality Management System consultant, will review common bottlenecks and productivity issues in audit Management and the possible ways to address them. Ensuring Closed Loop CAPA in Quality Management System Corrective and Preventive Action (CAPA) is the core of a sound quality Management system and is at the center of programs such as ISO 9000 and Six Sigma that focus on continuous improvement. In this webinar, we will review common bottlenecks and productivity issues in CAPA Management and demonstrate key capabilities of the MetricStream solution that ensure a closed loop CAPA process. How to Implement Change Control: Best Practices for Operational Excellence An enterprise wide change Management solution is a key requirement for managing and controlling change for operational excellence as well as for regulatory compliance. In this webinar, we will review common bottlenecks and issues related to change control and how to implement it across your own industry sectors and it?s best practices by leveraging a paper-less and workflow-based system. Best Practices in Supply Chain Governance and Performance Management In this webinar, Simon Jacobson, Senior Research Analyst at AMR Research, will cover the challenges that companies face in managing global suppliers and contract manufacturers. We also take a look at how world class organizations are implementing supply chain governance and performance Management programs to address their supplier quality related challenges. How 5 Fortune 1000 Hi-tech Companies are Driving Operational Excellence with MetricStream Top hi-tech manufacturing companies are transitioning from disjointed quality processes to an integrated approach to reduce costs, shorten cycle times and improve overall product and process quality. Using real-world customer case studies, this webinar will discuss how companies are using the MetricStream to achieve best-in-class operational performance. Techniques to Address Supplier Quality Management Challenges in High Tech Manufacturing Industry This webinar covers the impact of a distributed supply chain, managing supply chain risk, streamlining Supplier Corrective Action Requests (SCAR) and supplier audits, Deploying Supplier Scorecards, Implementing cost recovery and chargeback programs and calculating and reducing the cost of poor quality. Achieving CGMP Compliance - A Case Study Builing a case for implementing document Management automation by highlighting the tangible costs and risks of the manual system. The inefficiency of managing document control on spreadsheets, the lack of visibility into status, and bottlenecks in the review cycles leading to unpredictable review cycle times, the disparities in the quality practices at various facilities, and the risks and challenges of managing more than one copy of an SOP in a growing organization were easy to demonstrate. Automating The Corrective Action Process - A Case Study How MetricStream CAPA Management solution has tied together all the loose ends of the CAPA process by providing an automated and transparent environment for a designer, manufacturer and marketer of a line of casual shoes, rugged outdoor and work footwear. Best Practices In Supplier Quality This webinar covers the challenges companies face in managing global suppliers and contract manufacturers, and takes a look at how world class organizations are managing quality in their supplier network by using robust Supplier Quality Management systems. Building A Business Case For A Quality Management System This webinar discusses how to build a business case to justify a Quality Management System covering various aspects involved such as metrics, assumptions, data to be collected and building a financial model. CAPA For FDA Regulated Industry: Identifying And Resolving Common Bottlenecks And Productivity Issues In CAPA Management This webinar covers CAPA elements and MetricStream capabilities for accelerated CAPA investigation, approval, and closure with automated workflows, independent processes for containment, corrective, and preventive actions, improved communication and teamwork with parallel and sequential activities and real-time reports and dashboards for the CAPA process metrics and analytics. Delivering Quality Patient Care: Implementing Best Practices Supported By It Systems This webinar discusses how leading healthcare organizations are leveraging powerful IT systems to offer high-quality healthcare by implementing solutions for managing audits, executing corrective and preventive action (CAPA) plans and for handling customer complaints. Designing An Efficient ISO 9001:2000 Process For An Effective Quality System This webinar discusses how the standard can be used to develop your Management system. The five major sections of the standard are described, key clauses of each identified and the methodology for complying with the standard. Effective Safety And Quality Management In The Airline Industry For Improved Business Performance This webinar covers enterprise-wide visibility into the audit process and metrics for assured compliance with FAA regulations and internal standards, automatic assignment and tracking of audit tasks leading to an accelerated audit process, elimination of audit errors and inconsistencies with standardized data collection and analysis and improved communication and teamwork on complex audit processes across departments and functional areas. Ensuring Closed Loop CAPA This webinar reviews common bottlenecks and productivity issues in CAPA Management and demonstrates key capabilities of the MetricStream solution that ensure a closed loop CAPA process. Ensuring Closed Loop Compliance To Safety, Quality And Audit Standards In The Food and Beverage Industry This webinar examins the components of a food safety and HACCP compliance program identifying a hazard, critical control point and corrective and preventive action (CAPA), identifying needed documentation, third party audits. Enterprise-wide NCM And CAPA Management For Regulatory Compliance And Cost Reduction This webinar reviews common bottlenecks and productivity issues in nonconformance and corrective action Management and demonstrate key capabilities of the MetricStream quality Management solution that address them. FDA's Risk-based Method To Prioritize Cgmp Inspections For FDA Regulated Industries This webinar covers risk estimation, filtering and ranking, desirable attributes of an idealized risk categorization system for risk ranking, hazard identification and conceptual modeling, development of risk ranking model, implementation of the model and risk estimation, best of breed processes and tools used in the industry for risk estimation, filtering and ranking. How To Choose A Quality Management System For A FDA-regulated Environment This webinar reviews the key requirements of a FDA 21 CFR Part 11 compliant Quality Management System with key capabilities such as document control, deviations handling, CAPA and Management dashboards. Integrated Quality And Compliance Management For The Life Science Industry This webinar explores how leading pharmaceutical and medical devices companies are taking an integrated approach to quality and compliance Management and leveraging technology and automation of key business processes to improve operational efficiencies, lower the cost of regulatory compliance and create a transparent environment for proactively identifying, tracking and resolving quality and compliance issues. Managing Nonconformance And Corrective Actions For Sustainable Compliance In this web seminar, we will review common bottlenecks and productivity issues in nonconformance and corrective action Management and demonstrate key capabilities of the MetricStream quality Management solution that address them. Managing Quality In An Outsourced Manufacturing Model The presentation discusses how outsourcing changes the dynamics of a quality Management system and reviews implementation of a supplier quality system by a leading performance golf equipment company that out-sources the manufacturing of its golf club heads to its various manufacturing partners. Metricstream Quality Management Solutions For Manufacturing This webinar discusses how TCS and MetricStream are working together to offer an integrated solution for successfully meeting these requirements while lowering the associated costs that can otherwise be substantial. MetricStream uniquely combines software and content to deliver solutions for effective and sustainable compliance with embedded best practices templates, access to training content from an expert community, and integration of business processes with regulatory notifications and industry alerts. Coupled with TCS' domain expertise, Global Network Delivery Model (GNDMT) and global deployment experience, the TCS-MetricStream partnership is a compelling value proposition for global customers operating in a variety of regulatory environments and facing unique compliance challenges. Quality And Compliance In Automotive Industry This webinars discusses approaches, tools and strategies for attaining excellence though integrated quality and compliance Management such as how to measure and reduce cost of quality to improve line utilization, closed-loop Management of nonconformance, CAPA, auditing processes, track continuous improvement with real-time visibility into quality metrics and assure compliance with standards and regulations such as ISO16949, OSHA and EHnS. Role Of Technology In An Effective Quality Management System The speaker will share experiences and observations from his time auditing companies to ISO 9001:2000 and other Management systems on key considerations when replacing paper with technology and how technology can best be used to provide sound information for Management decision making. Streamlining Complaints Management For FDA Compliance This webinar reviews common bottlenecks and productivity issues in complaints Management and demonstrate key capabilities of the MetricStream Complaints Management solution that address them. Supplier Quality Management: 5 Best Practices To Achieve Operational Excellence This webinar reviews 5 Supplier Quality Management Best Practices to achieve operational excellence Management and how they can be implemented using real-world examples. Surviving an FDA Inspection: Understand the Do's and Don'ts and the Ground Rules This webinar reviews the do's and don'ts and cardinal rules of interviewing, responding, reviewing documentation, etiquette, use of certain words, body language, etc. This webinar has emphasis on the company's SOP on dealing with inspectors and knowing how to be prepared, proactive,and being able to defend and justify... and what it takes to achieve a favorable outcome. CAPA for FDA Regulated Industry A robust Corrective and Preventive Action (CAPA) program is of utmost importance to the FDA regulated industries. Implementation of a systematic and consistent CAPA process helps to investigate, identify and eliminate nonconformances, which in turn ensures regulatory compliance and cost savings. Top

Datasheets Environmental Health and Safety Solution Sheet Workplace safety is emerging as one of the key risk management and regulatory compliance areas. MetricStream's solution for EHandS enables organizations to effectively comply with regulatory mandates by providing a common framework and an integrated approach for risk management, document control, compliance training, ongoing auditing, as well as recording and reporting of safety issues and events and the resulting corrective actions. Food and Beverage Solution Sheet Mandates by the FDA and the USDA such as HACCP procedures and ISO 22000-based food safety management systems are the basis for many quality and compliance programs in the food and beverage industry. MetricStream solutions that enable food and beverage companies to capture, route, correct, prevent, and analyze system-wide issues between their organization and their trading partners. ISO 9000 Compliance Solution Sheet Many organizations are deploying industry standard quality management methodologies based on ISO 9000 or related specifications developed for specific industries such as TS 16949 for the automotive industry and ISO 13485 for the medical device industry. MetricStream offers the industry's most advanced and comprehensive suite of quality management solutions ideally suited for companies with multiple product lines and service offerings. CAPA Management Datasheet Corrective Action/Preventive Action (CAPA) is the core of a sound quality management system and is central to a closed loop, continuous improvement process. MetricStream CAPA is a comprehensive solution that enables companies to streamline their CAPA processes across the enterprise. Dietary Supplements Solution Sheet Although the industry strives to regulate itself to meet high quality standards, there is increasing involvement of the FDA and tighter regulations are being proposed. Leading companies are replacing their point solutions and paper-based systems with MetricStream solutions to automate their quality management processes, gain real-time visibility into their quality metrics, lower their cost of regulatory compliance and reduce their risk of non-compliance. Emission Management Solution Sheet The MetricStream solution for emission management enables an organization to manage, measure and report on environmental indicators by implementing an integrated emission management program and streamlining all the underlying business processes. Healthcare Solution Sheet Technology and innovation are playing central role in how healthcare companies are streamlining operational practices, service delivery procedures and records management while meeting regulatory requirements and industry standards such as JCAHO, HIPAA and other national and state regulations for patient safety. MetricStream provides industry?s most advanced and comprehensive suite of solutions to support compliance and quality programs for healthcare service providers. Case Management Datasheet By taking an integrated process approach and deploying a single system for issue management initiatives, compliance effectiveness can be increased while cost of compliance is reduced. MetricStream solution for Case, Incident and Complaint Management is a comprehensive solution that enables companies to establish and follow consistent procedures for issue capture, exception logging, loss event tracking, task management and status reporting. Nonconformance Management Datasheet Managing material and process nonconformance to minimize its impact on the product quality and ensuring that the cause of the nonconformance is uncovered and eliminated is one of the central functions of an organization's quality unit. The MetricStream solution supports identification, evaluation, segregation and disposition of nonconforming material as well as case investigation and tracking, possibly leading to a corrective action (CAPA). Customer Quality Management Solution Sheet Visionary organizations are realizing that handling and resolving product quality issues reported by customers in a consistent and predictable manner is key to customer loyalty and repeat business. MetricStream offers the most advanced and comprehensive solution for customer quality management in the industry today. High Tech Solution Sheet The growing mix of complex products and global expansion of operations requires a new approach to quality management to face the intense competition. MetricStream offers industry's most advanced and comprehensive suite of quality management solutions ideally suited to multi-site manufacturing, contract manufacturing and assembly operations in the High Tech industry. Medical Devices Solution Sheet Medical device manufactures are constantly pushing the boundary of innovation and delivering more powerful products. While the market welcomes the rapid advances, manufactures are expected to meet the rising standards of quality and comply with rigorous regulatory requirements. Leading companies are replacing their point solutions and paper-based systems with MetricStream solutions to automate their quality management processes, gain real-time visibility into their quality metrics, lower their cost of regulatory compliance and reduce their risk of non-compliance. Pharmaceuticals Solution Sheet The pharmaceutical industry is constantly being challenged to meet the rising standards of quality and to comply with rigorous regulatory requirements. MetricStream offers industry's most advanced and comprehensive suite of quality and compliance management solutions that serves the unique needs of the pharmaceutical industry. Supplier Quality Management Solution Sheet Supplier Quality Management is a critical business process for manufacturers who source components and parts from suppliers, whether the suppliers are just across the street or a continent away. MetricStream offers the most advanced and comprehensive solution for supplier quality management in the industry today to achieve complete automation of supplier quality management and gain real-time visibility into their suppliers' quality processes resulting in significantly lower cost of poor quality. Quality and Compliance Management Solution Sheet Combination of product proliferation, outsourced manufacturing operations, a stringent regulatory environment and rigorous customer requirements has created a need for organizations to proactively manage their quality and compliance processes. MetricStream offers comprehensive quality and compliance management software solutions for managing quality programs within an organization, for streamlining quality processes involving suppliers and customers, as well as for managing operational regulatory compliance such as FDA cGXP, OSHA, HACCP, JCAHO, etc. Top

Case Studies Safety and Operational Audit Solution for an Airline As one of the largest airlines with scheduled jet service to approximately 150 destinations, having effective quality and safety management systems with necessary control framework is critical for the company to ensure safety of the passengers and meeting regulatory compliance requirements. Automating Document Management for Efficiency, Visibility, and FDA Compliance A global chemistry-based drug discovery, development and manufacturing company: The Customer has achieved end-to-end automation for management and control for all types of documents such as SOPs, regulatory filings, cGMP and internal quality requirements. All documents are stored in central repository and with clearly defined lifecycle stages, templates, classification methods, search parameters, numbering schemes, revision control and association and obsolescence rules. Aligning Global Quality Processes with Customer Focus One of the largest and most well-known semiconductor companies: Given the complex nature of semiconductor manufacturing and the varied scenarios in which they are used, the company works closely with its customers to ensure responsiveness to and alignment with customer needs. Handling and resolving product quality issues reported by customers in a consistent and predictable manner is key to customer retention. Ensuring ISO 9000 Compliance by Automating CAPA to Strengthen the Core of Quality Management A DoD supplier and a leading manufacturer of branded footwear and performance gear: Any user can access the solution from her desktop and initiate a CAPA based on an exception such as a material nonconformance or a process variance and assign it to an owner with a due date. The entire process is automated with the information flowing as per predefined workflows. ISO 9000 in Electricity Transmission and Distribution The first electric utility to obtain ISO 9001:2000 registration for electricity transmission and distribution processes: The utility believes that quality management has taken a different shape and form with much less energy spent on making the process work. The focus has shifted to improving process and quality metrics that impact the customer the most. MetricStream solution ties together all the loose ends of the quality processes by providing an integrated platform based solution. Excellence in Quality and Compliance in Patient Care through Automated Business Processes One of the most dependable healthcare companies with over 56, 000 health professionals: The MetricStream solution has been implemented to automate and improve auditing, corrective actions and complaints handling - critical business processes that support delivery of quality patient care. The system provided a complete set of pre-defined, standard, role-based workflows that were rapidly configured based on customer's own business rules and policies. Automated and Efficient Product Issue Tracking for Enhanced Customer Satisfaction A Fortune 1000 company and a leading Flash Memory brand: To deliver best-in-class and consistent quality, reliability and process excellence initiatives across its diverse products portfolio and customer profile, the Company has a central Corporate Quality function that oversees quality programs for handling and resolving product quality issues reported by customers as well as compliance with regulatory and customer mandates such as RoHS Directive and ISO 14000. Excellence in Quality and Compliance through System Alignment and Integration A Fortune 500 manufacturer of diesel engines: The company has established well defined processes to comply with key industry standards and regulations such as QS 9000, TS 16949, ISO 18000, OSHA, Six Sigma, ISO 14000 and Environmental Health and Safety. By leveraging a common infrastructure for all its quality and compliance applications, the Company has achieved enterprise-wide visibility and control which localized point-applications did not provide. Streamlining Quality Management Processes in High Growth Enterprises A Fortune 1000 manufacturer of unified storage systems: The company had instituted a Root Cause Corrective Action (RCCA) Seven Step Process and terminology that was standardized across its worldwide locations. The company needed an enterprise-wide system to implement its RCCA methodology consistently and to ensure that investigation and resolution of quality problems and communication on progress was done in a uniform manner across the organization. Supplier Quality in a Flat World A Fortune Global 200 corporation with over $38 Billion in revenues: By implementing the MetricStream solution, the Company has achieved tremendous efficiencies and complete traceability in its supplier quality management process, across it businesses and supplier base. The system provides comprehensive metrics for measuring supplier performance based on PPM data, Cost of Poor Quality and SCAR results. Designed to support over 2, 000 users globally, the MetricStream supplier quality management solution handles 12, 000 SCARs across 1, 500 suppliers. Achieving cGMP Compliance The company focused on drug discovery, pharmaceutical development, and manufacturing for many of the world's leading healthcare companies: The built a case for implementing document management automation by highlighting the tangible costs and risks of the manual system. The inefficiency of managing document control on spreadsheets, the lack of visibility into status, and bottlenecks in the review cycles leading to unpredictable review cycle times, the disparities in the quality practices at various facilities, and the risks and challenges of managing more than one copy of an SOP in a growing organization were easy to demonstrate. Automating the Corrective Action Processes Designer, manufacturer and marketer of a line of casual shoes, rugged outdoor and work footwear: There was a complete lack of visibility into review cycle times, open CAPAs, repeat issues, average closure times, etc. limiting the ability to view trends for proactive preventive actions and making it nearly impossible to get process improvement metrics. MetricStream CAPA Management solution has tied together all the loose ends of the CAPA process by providing an automated and transparent environment. Managing Quality in an Outsourced Manufacturing Model A leading performance golf equipment company: The company out - sources the manufacturing of its golf club heads to its various manufacturing partners. With their dedication to being the best performance golf brand in the world, supplier quality management is a key component of their outsourced manufacturing strategy. The presentation discusses how outsourcing changes the dynamics of a quality management system and reviews their own implementation of a supplier quality system. Top

Solution Briefs Supply Chain Governance Solution Business models around the world are changing dramatically. Firms have shifted away from a hierarchical, one-dimensional supply chain entity to a fragmented network in favor of strategic partnerships with external entities. Thus, facing challenges and struggling to compete in this new landscape. Supply Chain Governance can help organizations to streamline and manage their supplier quality and supplier performance. Integrated Quality and Compliance Management The growing mix of complex products, a global supply base and stringent customer requirements has created a need for organizations to have real-time visibility into their quality processes and to implement systems that ensure closed loop quality processes and support easy access to and efficient routing of information. Many organizations are deploying industry standard quality management methodologies such as ISO 9000, cGMPs and Six Sigma or implementing other quality practices to reduce costs, shorten cycle times and improve overall product and process quality. Integrated Quality And Compliance Management in the Life Sciences Industry Companies in pharmaceutical, biotechnology and medical devices industries are constantly pushing the boundary of innovation to develop new products. In addition, the industry is regularly being challenged to meet the rising standards of quality and to comply with rigorous regulatory requirements. For Life Sciences companies, regulatory requirements such as FDA GXPs, reporting mandates, international quality and safety standards and other compliance issues are evolving from isolated departmental initiatives to an enterprise level challenge. ISO 16949 Compliance: Solution Brief Leading automotive manufacturers and suppliers use MetricStream Solutions to automate their internal quality control processes, ensure compliance with ISO 16949 standards and regulations, improve supplier quality performance, reduce warranty and recall liabilities. Supplier Quality Management: Solution Brief The global manufacturing industry has become a web of suppliers and customers linked together in a complex supply and demand chain. A critical aspect of a manufacturer?s business strategy is collaborating with suppliers across the globe in real-time to meet its product delivery schedules and design and quality commitments to its own customers. Ensuring conformance to product and process quality specifications and standards becomes is challenging task when the interacting manufacturers have disparate IT systems, different production schedules and dissimilar process metrics. Top