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Intelligent Regulatory Compliance Reporting with XBRL
Businesses have dealt with financial data, information, reporting, and disclosures what they have not dealt with is the amount of accuracy and reliability companies require these days. Regulations, legislations have always been there, what has changed is their rigor. Clearly making regulatory environment very complex and severe and also leaving the companies grappling with ways on how they go about demonstrating, documenting and reporting compliance.


Sustaining SOx compliance at significantly lower costs by employing Sarbanes Oxley software
According to a number of studies released recently, most companies have spent significantly more than they had budgeted on SOx 404 compliance. As companies look to the subsequent years of SOx compliance, they are looking to find ways to make compliance with SOx sustainable at lower costs.


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.


New User Access Requirements For 100% Compliance
By removing any barriers to easy access and use, companies can ensure 100% adoption of the application. This paper addresses how the next generations of compliance systems are addressing these key issues.


The Auditor’s Role in Adding Organizational Value - Aligning various aspects of GRC auditing to fulfill the new responsibilities
This articles talks about how auditors can contribute to streamlining GRC program by evaluating its effectiveness and aligning various aspects of GRC auditing, thereby fulfilling the new responsibilities and adding immense organizational value. 


Sound and effective Compliance Risk Management in Banks
Over the last decade, the business world has faced unprecedented changes and challenges, resulting in a slew of compliance regulations. Banks of all sizes are now more concerned than ever about compliance risk management. New banking products, increased government scrutiny and intense focus on compliance requirements bring forth greater risks and a larger set of rules and regulations.


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.


Raising Your Audit Score Through Effective Document Control
By carefully integrating document control with Compliance and Quality processes large and mid-size manufacturers can significantly enhance their audit scores. Many organizations who viewed document control and quality control as separate initiatives in the past are now increasingly taking an integrated approach to compliance and quality building a robust quality infrastructure on a strong foundation of document controls.


Reducing New Product Introduction (NPI) Time Using A Packaged Software Solution
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.


Reducing The Cost Of Sox Compliance - Learning From ISO9000 Implementation
The techniques that helped a manufacturer reduce the cost of staying compliant with ISO9000 will also enable a CFO to sustain SOX 404 compliance at significantly lower costs.


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.


Sarbanes-Oxley And It Controls
IT systems play a critical role in ensuring the accuracy of a company's financial reports. As a result, validation of IT controls is a key part of Sarbanes-Oxley compliance initiative.


Smart Investment Strategies For A Compliance Platform: A Ten Step Guide
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 manage regulatory and compliance initiatives within respective operational and departmental areas.


SOX Compliance
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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.


Streamlining The It Audit And Compliance Process
Almost all financial reporting processes in an organization are driven by IT systems. As a result of their tight linkage to the overall financial reporting process, internal controls over relevant IT systems need to be assessed for their compliance with the Sarbanes-Oxley Act (SOX). Other regulations such as FDA, GLBA and HIPAA also require assessment of internal controls of relevant information systems.


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
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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.


The Best Practice Guide For Managing SOX 404 Compliance
Embracing this 10 Step process will ensure higher SOx compliance and greater quality and operational benefits at a signifcantally lower compliance cost.


Using A Compliance Platform To Build Custom Compliance And Quality Applications
Any custom application built on a compliance platform automatically gets access to all the common services defined within the platform. As a result, development of a custom compliance and quality application/module is practically reduced to defining and programming the process logic and user interface forms - the application/module leverages the platform for common services that it would have to build otherwise.


Risk Management: Whose job is it anyways?
Companies today are exposed to risks and threats that were virtually unknown 10 or 15 years ago. Although the traditional risks, such as credit risk and market risk, remain key considerations, companies are also recognizing human capital risk, regulatory risk, information technology risk and tail risks such as terrorism and climate change as major threats.


Improving Healthcare Quality and Ensuring Patient Safety
Patient safety management has emerged as one of the pivotal concerns of the healthcare industry since the 1990s. Over the years, several faulty health care processes have resulted in severe patient injuries to fatal accidents, drawing negative media and public attention.


Delivering Business Performance through Integrated Governance, Risk and Compliance
MetricStream is the market leader in integrated Governance, Risk and Compliance (GRC) Management solutions that provide Risk Intelligence for driving business performance. MetricStream provides a wide range of easy-to-use applications on a proven platform to enable a systematic approach to defining and managing GRC initiatives through a sustainable and integrated process that is aligned with the corporate strategy objectives.


Managing Risks as Businesses Go Global, Virtual, Social and Mobile
Businesses are going more global, virtual, social and mobile. Trends like use of virtualized infrastructure, proliferation of mobiles devices, reliance on suppliers, adoption of cloud applications, and ubiquity of social media are introducing a whole new class of risks that enterprises need to deal with. MetricStream provides a unique top-down approach of integrating Business, IT and Security on a common GRC Platform for simplifying corporate governance, risk management and regulatory compliance to help correlate emerging risks to business strategy, operations and performance.


Manage Risks to Comply with Food Audits
Despite stringent standards and extensive audits on food safety, food poisoning sickens around 76 million Americans and kills over 5000 each year. Most of the fatalities arise from botulism, salmonellosis, and staphylococcal food poisoning. The emergence of a class of new drug resistant pathogens such as campylobacter jenjuni, shiga toxin-producing E. coli, Listeria monocytogenes and cyclospora cayetanensis have complicated matters further.


Enterprise-Ready GRC Applications
MetricStream GRC Platform provides enterprise-ready technology architecture to supports global scale of operations, complex organizational structures and heterogeneous IT environments enabling seamless integration of all GRC processes and systems in a single, cohesive framework.


Audit Management Tools - Food Safety Audits and Inspections
Fresh from the farm - a reality once is now a long drawn past. Call it a lifestyle issue or just a matter of convenience more and more people are today consuming pre-cooked or packaged food. ‘Nothing to fear’ says the FDA with a stamp on every jar of the peanut butter, ensuring the safety of Americans who consume it.


Is Your Enterprise Ready To Beat Off A Cyber Attack?
The recent release of confidential US government cables on WikiLeaks has set more than a few companies wondering about the security of their critical information infrastructure and business data. And as the dust of the WikiLeaks saga was only just settling, an international trading platform with high and multiple levels of security was hacked.


How to Put Together an Effective Audit Program
Putting together a streamlined Audit plan is a complex task for most of the audit managers. Audit Managers come across various obstacles in a streamlined audit plan and these issues either cost focus of major audit tests or increased time.


Enforcing Policies Key to Managing Compliance Programs in Energy and Utilities
Energy and utilities organizations are facing a rapidly changing business environment. With growing cyber threats on one side and complex regulatory requirements on the other, organizations find themselves struggling to strike a balance between managing and monitoring numerous auditable tasks and compliance activities related to FERC, NERC, ERO, NRC and other regulatory requirements.


What is the ROI of a CAPA Management Solution?
For any organization, Corrective and Preventive Action (CAPA) system is a critical part of the quality management program, both for regulatory compliance and for continuous improvement initiatives. As business complexity and size grow, it is natural for quality managers to consider replacing existing paper-based systems, spreadsheets or isolated databases relied upon for managing the CAPA processes, with an integrated and centralized system that can support the CAPA process across the organization consistently and reliably.


Gaining a Competitive Edge through Compliance with Basel III
As the world recovers from a crippling financial crisis, the Basel Committee on Banking Supervision has stepped up its efforts to improve the resiliency of the financial sector. On September 12, 2010, the Group of Governors and Heads of Supervision - the oversight body of the Basel committee - announced a substantial strengthening of existing minimum capital requirements for banks.


9 Key Strategies To Minimize The Cost of Poor Quality
For many organizations, quality-related costs go as high as 15 to 20 percent of their sales revenue, with some even going up to 40 percent of total operations. Ideally, for a company to thrive, cost of poor quality should be 10 to 15 percent of the operation cost. However, an effective quality management program can lower this cost substantially.


Workplace Safety Compliance: The New Approach
Workplace Safety is emerging as one of the key risk management and regulatory compliance focus areas among many global companies. As a result of this trend, traditional workplace safety compliance systems, which were designed to be point solutions at a plant-level, are giving way to enterprise-wide safety management systems.


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