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Case Studies
Automating Compliance Management
The company embarked on an initiative to fully comply with Sarbanes-Oxley regulations. As the company evaluated its current state of compliance preparedness, it identified a number of inherent challenges. The company managed regulatory changes in silos, focused narrowly on compliance, and used compartmentalized regulatory controls....
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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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Integrated Risk and Compliance Management for Banks and Financial Services Organizations: Benefits of a Holistic Approach
Banks and financial services organizations of all sizes are now more concerned than ever about risk and compliance management. This white paper discusses the current risk and compliance environment for banks and financial institutions, strategies for successfully implementing Governance, Risk and Compliance (GRC) programs and how technology can be leveraged to adopt a holistic approach to risk and compliance management.
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Governance, Risk and Compliance Framework
Growing regulatory environment, higher business complexity and increased focus on accountability have led enterprises to pursue a broad range of governance, risk and compliance initiatives across the organization. However, these initiatives are uncoordinated and potentially increase the overall business risk for the organization. This is leading organizations to take a unified approach to GRC. This paper details the various steps and benefits of implementing Unified GRC strategy.
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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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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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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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| Webinar |
Next Generation Internal Audit: The Chief Auditor's perspective
In this panel discussion, Chief auditors for global corporations discuss and debate about the next generation of internal audit that is more adaptable, collaborative, and integrated with corporate goals.
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Unlocking the Elusive Potential of a Unified GRC Program
This webinar showcases how unified GRC program helps organizations in overcoming challenges associated with risk and compliance management dependant on manual or point solutions. GRC systems and processes provide an integrated picture of Governance, Risk, and Compliance information and processes across the business - resulting in agility, efficiency and effectiveness of risk and compliance processes ? as opposed to complexity, redundancy, and failure associated with manual or point solutions.
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The Changing Face of Internal Audit
This panel will discuss the evolving role of Internal Audit and its impact on driving effective risk management program across the enterprise that can address the changing business landscape and enhance the ability to react rapidly to adverse events.
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Integration of SOX and Operational Audits
This webinar details how the shift toward SOX and general compliance related duties demand the rebalancing and seamless integration of SOX and Operational Audits to meet the requirements of the law without it being detrimental to other responsibilities of auditors.
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Upgrading Internal Audit Infrastructure
This webinar on Upgrading Internal Audit Infrastructure provides a complete perspective on identifying key challenges in managing internal audit in today?s environment, describing the scope of upgrade including the impact on organization, and defining the technology infrastructure necessary to support the upgrade.
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Implementing Integrated GRC Program in an Organization
This session with Chris McClean, Analyst, Forrester Research, looks at the various functions involved in GRC, common areas of differences and divergence and strategies for overcoming these organizational obstacles to arrive at a common language and approach that all business owners agree upon, accept and adopt in their functions.
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Beyond Basel II Compliance: Integrated Operational Risk Platform as a Competitive Differentiator
This MetricStream hosted webinar on "Beyond Basel II Compliance: Integrated Operational Risk Platform as a Competitive Differentiator" highlights how a holistic approach to risk management tied into corporate governance be a competitive advantage.
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Thriving In The Face of Regulation: How to Accommodate the New Regulatory Regime and Achieve Optimum Business Performance
In this on-demand Webcast, our distinguished panel members from their vast real-world regulatory, management and advisory experiences, discusses on what top governance and compliance mistakes to avoid and what essential policies and procedures to implement.
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Linking Internal Audit Plan with Organizational Strategic Goals
In this webinar, Dr. Robert M. Mark, Former CRO of CIBC provides insights on incorporating a risk based policy, methodology and infrastructure benchmark assessment, ensuring risk appetite across the organization, evaluating an organization?s strategies to assess risk, and defining the technology infrastructure necessary to support the new Internal Audit norms.
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Five Trends in Internal Audits
In this webcast, based on our engagements with several large organizations relying on MetricStream solution for managing its audit, risk and compliance processes, we will discuss about the Five key Trends that we observe in Internal Audits.
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Risk-based Internal Audit Management
This MetricStream hosted webinar helps to get a complete perspective on adopting risk-based Internal auditing framework for improving business performance, Creating a risk-centric environment for managing new threats and challenges, and Enabling technology to cope with the changing role of Internal Audit function
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Managing Risk and Internal Audit in a Bank
This complimentary webinar provides a great opportunity to hear the views of a former chief risk officer of one of the leading financial services organization on improving business performance through an integrated GRC framework, developing risk-based internal audit program for a bank, creating a risk-centric environment for managing new threats and challenges, and enabling technology to cope with the increasing complexity of compliance landscape.
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Risk, Audit and Compliance Management: GRC Platform and Solutions
In this webinar, we discusses what role can integrated Governance, Risk and Compliance (GRC) play in meeting the evolving needs of global corporations and the rising expectations of investors, regulators and the board, as organizations consider new techniques to succeed in managing risks, compliance and controls.
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GRC at its Inflection Point: How Risk, Compliance and Internal Audit Will Change Business in 2009
In this online event, Forrester Research Analyst, Chris McClean, discusses key imperatives that have brought GRC to its inflection point such as creating a GRC program that focuses on business value, linking GRC performance metrics to strategic goals, managing increasing scrutiny and oversight of business practices, supporting the role of internal audit and reducing GRC cost and complexity.
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Run up to the Economic Crisis: Enabling Risk Management
For Risk Officers, the events of the past year have challenged all assumptions about what defines the best practices of governance and risk Management. In particular, the appropriateness of the Chief Risk Officer?s dual, and potentially conflicting, roles of working to advance the business and acting as a provider of ?independent? oversight are being questioned. In this webinar, we will discuss an integrated framework for deploying governance and risk Management practices that will lead to higher adaptability for changing business needs and enhancing capabilities that will guard against adversity.
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Best Practices In Computer System Validation
In this presentation, Tim Stein - an industry stalwart, author and consultant for computer systems validation - discusses best practices for meeting requirements for computer system validation. Tim bases his presentation on his book, The Computer System Risk Management and Validation Life Cycle , Paton Press, 2006.
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Enterprise Risk Management (ERM) In The Extended Enterprise: Including Planning For New Standard And Poor's Erm Guidelines For Non Financial Companies
The webinar covers key ERM principles and components defined in risk standards such as COSO ERM as well as AS/NZS 4360:2004, Standard and Poor's proposed implementation of ERM in companies for their respective debt rating evaluation process and integration of Enterprise Risk Management and Internal Audit standards, methodologies, recommendations and legislation
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Implementing NERC CIP Compliance Requirements In A Phased Manner
NERC CIP framework includes eight compliance standards focused on protecting energy entities. Non compliance mandated through compliance enforcement program (CEP) may lead to heavy penalties. Key to ensuring compliance requires implementation of an integrated framework capable of managing multiple requirements across the enterprise. This requires a platform flexible enough to integrate multiple requirements across the enterprise. This webinar covers how to address key challenges facing energy companies in achieving compliance with NERC CIP.
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Linking The SOX Compliance Process To The Pcaob's Audit Standard Number 5 To Maximize Compliance Effectiveness
This webinar provides fundamental background on PCAOB's Standard No 5 and focuses on how companies can take advantage of the information provided in the standard to achieve cost-effective and sustainable SOX compliance.
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Sarbanes-Oxley And The It Controls
This webinar reviews how IT fits into the overall compliance assessment framework, offers key insights into IT controls review and IT controls compliance assessment processes and provides a checklist of key capabilities in any SOX compliance software to document, manage and assess IT controls.
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Streamlining It Audits
This webinar reviews IT audit challenges and solutions, how to use a framework such as COBIT to streamline the process and demonstration of technology that streamlines the IT audit process and provides a system of record for it.
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Streamlining It Audits And Compliance For Effective Risk Management
This webinar explores how companies are improving performance and driving down costs of IT compliance by implementing next generation IT-GRC systems.
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| Case Studies |
Automating Compliance Management
The company embarked on an initiative to fully comply with Sarbanes-Oxley regulations. As the company evaluated its current state of compliance preparedness, it identified a number of inherent challenges. The company managed regulatory changes in silos, focused narrowly on compliance, and used compartmentalized regulatory controls...
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