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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..
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Insights
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..
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| White Papers |
Compliance of Quality Management Systems with 21CFR Part 11 - a detailed analysis
The FDA introduced 21 CFR Part 11 in to effect on August 20, 1997. All companies and organizations that are in industries regulated by the FDA must follow these regulations.This document describes how MetricStream?s platform for quality and Compliance management is compliant with the regulations in the Food and Drug Administration?s 21 CFR Part 11 for electronic records and electronic signatures.
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Meeting 21 CFR Part 11 Requirements
Food and Drug Administration (FDA) introduced 21 CFR Part 11 (Part 11) regulations to promote wide usage of electronic technology in the life sciences industry in a way that is compatible with FDA's responsibility to protect public health. This paper discusses the various specifications of this regulatuions and suggests ways to address the Part 11 requirements in a cost efficient manner.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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| 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.
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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.
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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.
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Environment, Health and Safety Audit Systems
Environment, Health and Safety (EHnS) management is emerging as a key challenge for large organizations. Site safety and health programs benefit from effective planning, full implementation and careful, ongoing management. Correcting common deficiencies are important not only to protect the health and safety of site workers, but also to maximize the benefit and cost effectiveness of site health and safety programs.
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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.
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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.
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| Webinar |
Manage Supplier Quality in Global Complex Supply Chain
This complimentary webinar covers the challenges that company face in managing global suppliers and contract manufacturer, and provides insights on how to mitigate supplier quality problems with simple and reliable processes.
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How to Spot Supplier Risks through Supplier Score Cards
This webinar helps us to understand how to design supplier scorecard for multiple industries, use scorecard dashboard reports for decision making, integrate supplier risk management process with scorecard and mitigate supply chain and procurement risks, and manage supplier relationship process.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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| Datasheets |
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.
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Equipment Management Datasheet
For companies that are regulated by the FDA or are following quality standards such as ISO 9000/14000, accurate calibration and general maintenance of equipment is a critical factor for meeting established quality requirements for product and processes quality and reducing the risk of noncompliance. MetricStream Equipment Management is a comprehensive solution that enables companies to effectively manage equipment maintenance, repair and calibration.
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PCI Compliance Solution Sheet
MetricStream offers a comprehensive solution for sustainable PCI compliance based on industry best practices. The solution enables identifying key risks across the enterprise, conducting investigation for root cause analysis, defining controls for mitigating risks, and evaluating the effectiveness of controls through assessment plans while lowering the overall cost of compliance.
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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.
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| Case Studies |
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.
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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.
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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.
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| 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.
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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.
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