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MetricStream
(25 results)-
White Papers
Greening Supply Chain
January 1, 2011, 12:00am PST
With companies waking up to an environmentally aware world, whether it's about the competitive advantage or for regulatory reasons, greening the supply chain has become a necessity. Greening the...
Provided by MetricStream
-
White Papers
Enterprise-wide CAPA Management To Help Comply With FDA Requirements
January 1, 2011, 12:00am PST
With new products to market faster, customer satisfaction and compliance to FDA regulations, medical device manufacturers need to rethink their strategy for consistent, enterprise-wide compliance...
Provided by MetricStream
-
White Papers
IT Systems Validation for SOx and Regulatory Compliance: Importance of Information Systems Audit and Validation
August 31, 2006, 12:00am PDT
Information technology has become a core enabler of business processes within the organizations today. As a result, companies are required to audit and validate their relevant IT systems to ensure...
Provided by MetricStream
-
White Papers
Operational Benefits of Sarbanes-Oxley Compliance
August 31, 2006, 12:00am PDT
While many management teams, board of directors, audit committees see Sarbanes-Oxley Act of 2002 as an administrative and compliance exercise, this paper encourages companies to think...
Provided by MetricStream
-
White Papers
The Best Practice Guide for Managing SOx 404 Compliance: SOx Compliance Environment
August 31, 2006, 12:00am PDT
Over the last 12 months, the team at MetricStream has informally and formally talked to number of professionals in quality, compliance, internal audit; SOx program office, finance & external...
Provided by MetricStream
-
White Papers
Ensuring Regulatory Compliance Through Training and Certification: Role of Training and Certification in Regulatory Compliance
August 31, 2006, 12:00am PDT
There has been a dramatic growth in compliance and regulatory requirements across all industries. These federal regulations are the law-of-the-land and organizations covered under such regulations...
Provided by MetricStream
-
White Papers
Can't Get Budget Approval for Your Quality Management System?
August 31, 2006, 12:00am PDT
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...
Provided by MetricStream
-
White Papers
Corrective Action (CAPA) Systems at Innovative Companies
August 31, 2006, 12:00am PDT
Increased regulatory pressures, the latest customer mandates and internal quality initiatives are requiring companies to take a proactive and automated approach to their corrective action process....
Provided by MetricStream
-
White Papers
What Is Your Company's Cost of Poor Quality (CoPQ) - Tools for Calculating and Reducing It
August 31, 2006, 12:00am PDT
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...
Provided by MetricStream
-
White Papers
Impact of Regulatory Compliance on Quality and Profits
August 31, 2006, 12:00am PDT
Regulatory compliance by enterprises could result in a positive impact on quality of the product and services that they generate. This could imply that the results of compliance can be quantified...
Provided by MetricStream
-
White Papers
Paper-Based Quality System Is More Costly Than You Think
August 31, 2006, 12:00am PDT
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...
Provided by MetricStream
-
White Papers
Raising Your Audit Score Through Effective Document Control
August 31, 2006, 12:00am PDT
This paper discusses how one can most effectively raise the audit scores of an organization by building effective document control processes. Document control and document lifecycle management...
Provided by MetricStream
-
White Papers
Reducing New Product Introduction (NPI) Time Using a Packaged Software Solution
August 31, 2006, 12:00am PDT
In several industries, the total time taken to introduce a new product into the market can be the key difference between a blockbuster and a mediocre performing new product. New Product...
Provided by MetricStream
-
White Papers
Here Comes TS 16949
August 31, 2006, 12:00am PDT
The International Automotive Task Force (IATF) took on the challenge of developing a standard to harmonize three European catalogs-VDA 6.1 (Germany), AVSQ (Italy), EAQF (France)-and the North...
Provided by MetricStream
-
White Papers
Overview of 21CFR Part 11
August 31, 2006, 12:00am PDT
Pharmaceutical, medical device, biotechnology and services companies are challenged to ensure regulatory compliance through all their operations. A critical success factor is in their ability to...
Provided by MetricStream
-
White Papers
Change Control in the FDA-Regulated Industry
August 31, 2006, 12:00am PDT
Change control is the most critical element in a pharmaceutical or biotech company's quality management system - inadequate change control procedures end up creating a huge risk of non-compliance....
Provided by MetricStream
-
White Papers
Best Practices in Supplier Quality Management
August 31, 2006, 12:00am PDT
Supplier quality management has emerged as one of the leading business practices in the past few years. World-class manufacturers are making significant investments in systems and processes to...
Provided by MetricStream
-
White Papers
Quality in an Outsourced Economy
August 31, 2006, 12:00am PDT
Many companies across all industries have decided to focus on their core competencies and have outsourced manufacturing of some components, as well as specialty services to a partner, who may only...
Provided by MetricStream
-
White Papers
Quality System Requirements for Outsourced Manufacturing
August 31, 2006, 12:00am PDT
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...
Provided by MetricStream
-
White Papers
Quality Management for Outsourced Operations
August 31, 2006, 12:00am PDT
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...
Provided by MetricStream
-
White Papers
Supplier Charge-Backs
August 31, 2006, 12:00am PDT
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...
Provided by MetricStream
-
White Papers
The Next Generation of Systems for Compliance
August 31, 2006, 12:00am PDT
Companies are governed by a complex web of regulations, laws, voluntary codes, industry codes, and corporate policies. Compliance with these intricate regulations, mandates and policies is not an...
Provided by MetricStream
-
White Papers
Smart Investment Strategies for a Compliance Platform: A Ten Step Guide
August 31, 2006, 12:00am PDT
Government regulations and mandates are on the rise. Most corporate compliance offices are challenged to find compliance solutions that can scale across corporate compliance offices and also...
Provided by MetricStream
-
White Papers
New User Access Requirements for 100% Compliance
August 31, 2006, 12:00am PDT
One of the key requirements for successful compliance with regulations is that everyone who interacts with the relevant processes should follow the defined policies and procedures. Typically these...
Provided by MetricStream
-
White Papers
IT Systems and SOX Compliance
June 15, 2007, 12:00am PDT
IT plays a critical role in the operations of an organization. It is difficult to imagine a successful organization existing in the 21st century without some level of reliance on IT systems. In...
Provided by MetricStream
-
White Papers
Enterprise-wide CAPA Management To Help Comply With FDA Requirements
January 1, 2011, 12:00am PST
With new products to market faster, customer satisfaction and compliance to FDA regulations, medical device manufacturers need to rethink their strategy for consistent, enterprise-wide compliance...
Provided by MetricStream
-
White Papers
Greening Supply Chain
January 1, 2011, 12:00am PST
With companies waking up to an environmentally aware world, whether it's about the competitive advantage or for regulatory reasons, greening the supply chain has become a necessity. Greening the...
Provided by MetricStream
-
White Papers
IT Systems and SOX Compliance
June 15, 2007, 12:00am PDT
IT plays a critical role in the operations of an organization. It is difficult to imagine a successful organization existing in the 21st century without some level of reliance on IT systems. In...
Provided by MetricStream
-
White Papers
New User Access Requirements for 100% Compliance
August 31, 2006, 12:00am PDT
One of the key requirements for successful compliance with regulations is that everyone who interacts with the relevant processes should follow the defined policies and procedures. Typically these...
Provided by MetricStream
-
White Papers
Smart Investment Strategies for a Compliance Platform: A Ten Step Guide
August 31, 2006, 12:00am PDT
Government regulations and mandates are on the rise. Most corporate compliance offices are challenged to find compliance solutions that can scale across corporate compliance offices and also...
Provided by MetricStream
-
White Papers
The Next Generation of Systems for Compliance
August 31, 2006, 12:00am PDT
Companies are governed by a complex web of regulations, laws, voluntary codes, industry codes, and corporate policies. Compliance with these intricate regulations, mandates and policies is not an...
Provided by MetricStream
-
White Papers
Supplier Charge-Backs
August 31, 2006, 12:00am PDT
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...
Provided by MetricStream
-
White Papers
Quality Management for Outsourced Operations
August 31, 2006, 12:00am PDT
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...
Provided by MetricStream
-
White Papers
Quality System Requirements for Outsourced Manufacturing
August 31, 2006, 12:00am PDT
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...
Provided by MetricStream
-
White Papers
Quality in an Outsourced Economy
August 31, 2006, 12:00am PDT
Many companies across all industries have decided to focus on their core competencies and have outsourced manufacturing of some components, as well as specialty services to a partner, who may only...
Provided by MetricStream
-
White Papers
Best Practices in Supplier Quality Management
August 31, 2006, 12:00am PDT
Supplier quality management has emerged as one of the leading business practices in the past few years. World-class manufacturers are making significant investments in systems and processes to...
Provided by MetricStream
-
White Papers
Change Control in the FDA-Regulated Industry
August 31, 2006, 12:00am PDT
Change control is the most critical element in a pharmaceutical or biotech company's quality management system - inadequate change control procedures end up creating a huge risk of non-compliance....
Provided by MetricStream
-
White Papers
Overview of 21CFR Part 11
August 31, 2006, 12:00am PDT
Pharmaceutical, medical device, biotechnology and services companies are challenged to ensure regulatory compliance through all their operations. A critical success factor is in their ability to...
Provided by MetricStream
-
White Papers
Here Comes TS 16949
August 31, 2006, 12:00am PDT
The International Automotive Task Force (IATF) took on the challenge of developing a standard to harmonize three European catalogs-VDA 6.1 (Germany), AVSQ (Italy), EAQF (France)-and the North...
Provided by MetricStream
-
White Papers
Reducing New Product Introduction (NPI) Time Using a Packaged Software Solution
August 31, 2006, 12:00am PDT
In several industries, the total time taken to introduce a new product into the market can be the key difference between a blockbuster and a mediocre performing new product. New Product...
Provided by MetricStream
-
White Papers
Raising Your Audit Score Through Effective Document Control
August 31, 2006, 12:00am PDT
This paper discusses how one can most effectively raise the audit scores of an organization by building effective document control processes. Document control and document lifecycle management...
Provided by MetricStream
-
White Papers
Paper-Based Quality System Is More Costly Than You Think
August 31, 2006, 12:00am PDT
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...
Provided by MetricStream
-
White Papers
Impact of Regulatory Compliance on Quality and Profits
August 31, 2006, 12:00am PDT
Regulatory compliance by enterprises could result in a positive impact on quality of the product and services that they generate. This could imply that the results of compliance can be quantified...
Provided by MetricStream
-
White Papers
What Is Your Company's Cost of Poor Quality (CoPQ) - Tools for Calculating and Reducing It
August 31, 2006, 12:00am PDT
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...
Provided by MetricStream
-
White Papers
Corrective Action (CAPA) Systems at Innovative Companies
August 31, 2006, 12:00am PDT
Increased regulatory pressures, the latest customer mandates and internal quality initiatives are requiring companies to take a proactive and automated approach to their corrective action process....
Provided by MetricStream
-
White Papers
Can't Get Budget Approval for Your Quality Management System?
August 31, 2006, 12:00am PDT
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...
Provided by MetricStream
-
White Papers
Ensuring Regulatory Compliance Through Training and Certification: Role of Training and Certification in Regulatory Compliance
August 31, 2006, 12:00am PDT
There has been a dramatic growth in compliance and regulatory requirements across all industries. These federal regulations are the law-of-the-land and organizations covered under such regulations...
Provided by MetricStream
-
White Papers
The Best Practice Guide for Managing SOx 404 Compliance: SOx Compliance Environment
August 31, 2006, 12:00am PDT
Over the last 12 months, the team at MetricStream has informally and formally talked to number of professionals in quality, compliance, internal audit; SOx program office, finance & external...
Provided by MetricStream
-
White Papers
Operational Benefits of Sarbanes-Oxley Compliance
August 31, 2006, 12:00am PDT
While many management teams, board of directors, audit committees see Sarbanes-Oxley Act of 2002 as an administrative and compliance exercise, this paper encourages companies to think...
Provided by MetricStream
-
White Papers
IT Systems Validation for SOx and Regulatory Compliance: Importance of Information Systems Audit and Validation
August 31, 2006, 12:00am PDT
Information technology has become a core enabler of business processes within the organizations today. As a result, companies are required to audit and validate their relevant IT systems to ensure...
Provided by MetricStream
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