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Software Functionality Revealed in Detail
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 fda regulatory compliance reconsidered


Enhanced Courseware for Compliance and Risk Mitigation Training from Skillsoft
Skillsoft announced that it has added new content courses to its compliance and risk mitigation courseware collection. Skillsoft's compliance courses—available

fda regulatory compliance reconsidered  Courseware for Compliance and Risk Mitigation Training from Skillsoft Skillsoft announced that it  has added new content courses  to its compliance and risk mitigation courseware collection. Skillsoft's compliance courses—available on demand—are aimed at preparing individuals for exams and meeting regulatory requirements. The courses have been compiled in collaboration with subject matter experts and cover organization-specific legal requirements as well as ethics, bribery, harassment,

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Software Functionality Revealed in Detail

We’ve opened the hood on every major category of enterprise software. Learn about thousands of features and functions, and how enterprise software really works.

Get free sample report
Compare Software Solutions

Visit the TEC store to compare leading software by functionality, so that you can make accurate and informed software purchasing decisions.

Compare Now

Regulatory and Compliance

Regulatory compliance covers the requirements for ensuring products and their associated materials comply with both external and internal rules and regulations. It covers regulatory and requirements needs, as well as product related components of environmental health and safety (EH&S). 

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Documents related to » fda regulatory compliance reconsidered

Proactive IT Triage for Sarbanes-Oxley Compliance


When it comes to Sarbanes-Oxley compliance, most IT organizations do not lack measurement data—in fact, they’re buried in it! What they need are effective ways to put these measurements into the context of critical business services, establish baselines for every layer of every component, and proactively communicate which layer of which component is the root cause of any abnormality.

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Sarbanes-Oxley Compliance with ERP Software


For many companies, enterprise resource planning (ERP) is the single most important infrastructure element, thanks largely to its power in delivering end-to-end integration. New technology in ERP software has grown in sophistication over the years, enabling even further automation of business functions. Find out how you can leverage one ERP solution to deal with one of your biggest bugbears: Sarbanes-Oxley compliance.

fda regulatory compliance reconsidered   Read More

Tracking Limitations to Business Policies: Using Compliance-based Solutions as an Opportunity


Risk managers and compliance officials in banking institutions often face problems of how to measure and monitor risk and incorporate risk practices. Solutions to these problems must be linked to decision-making processes, but they also need to increase the speed at which institutions can react to market changes. Can new risk management solutions really deliver compliance in a verifiable, measurable, and timely manner?

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The Value of a Learning Management Compliance Solution


Companies spend millions each year conducting mandatory training. Whether triggered by an audit, the risk of non-compliance, bad PR, or internal training requirements, achieving compliance can be difficult and costly. One of the biggest challenges that organizations face today is reducing costs from fines and lawsuits. Download this white paper to find out how a learning management compliance solution can help manage your compliance requirements.

fda regulatory compliance reconsidered  SumTotal,government,learning management,learning management software,learning management solution,learning management solutions,learning management system,learning management system lms,learning management systems,learning talent development Read More

The Age of Compliance: Preparing for a Riskier and More Regulated World


The three themes of governance, risk, and compliance (GRC) have been central to the management agenda for a decade. But whereas years ago it was the “C” in GRC that kept executives awake at night (and indeed was the impetus behind the development of GRC in the first place), in the post-crisis world it is the “R” that has risen to the top of the agenda. Learn about a more efficient approach to managing risk and compliance.

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Compliance Exposures in ERP Systems Part 1


This paper examines key issues for CFOs and CEOs in managing ERP systems in the new world of SOX, IFRS, Basle II. While most IT management attention seems to be on document retention, reporting quality, and security, there are broader issues to be considered toward ensuring good governance and compliance with regulations such as Sarbanes-Oxley, IFRS and Basle II.

fda regulatory compliance reconsidered  Exposures in ERP Systems Part 1 Compliance Exposures in ERP Systems, Part 1 If you receive errors when attempting to view this white paper, please install the latest version of Adobe Reader. Founded in 2003, West Trax provides in-depth consulting services to large and mid-size national and international enterprises. Using its extensive subject matter expertise combined with proprietary tools and methodologies it aims to transform the value derived from clients? ERP investments. The company is Read More

Governance, Risk, and Compliance Management


Governance, risk, and compliance (GRC) issues are hot topics today, thanks to high-profile stories about companies that failed to meet regulatory requirements. In each case, executives were held accountable, stock prices dropped, and brand image suffered. Find out about cross-enterprise GRC solutions that can make it easier to monitor compliance and risk effectively, and adjust to changing regulatory mandates.

fda regulatory compliance reconsidered  Risk, and Compliance Management Governance, Risk and Compliance Management: Realizing the Value of Cross-Entreprise Solutions If you receive errors when attempting to view this white paper, please install the latest version of Adobe Reader. Founded in 1972, SAP has a rich history of innovation and growth as a true industry leader. SAP currently has sales and development locations in more than 50 countries worldwide and is listed on several exchanges, including the Frankfurt Stock Exchange Read More

Delivering Employee Compliance Training Online to Reduce Costs and Increase Productivity


Pacific Life needed to bring enterprise-wide learning technology into the company to ensure the success of compliance training. So it implemented a strategic compliance training initiative powered by SumTotal Learning Management to deliver critical online training and to streamline learning management across the enterprise. Find out the results of this initiative, including a shortened compliance training cycle by 82%.

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Regulatory and Compliance Software Evaluation Report


The Regulatory and Compliance Knowledge Base covers the requirements for ensuring products and their associated materials comply with both external and intenal rules and regulations. It covers regulatory and requirements needs, as well as product related components of Environmental Health and Safety (EH&S).

fda regulatory compliance reconsidered  and Compliance Software Evaluation Report TEC's Regulatory and Compliance Software Evaluation Report allows you to compare and analyze the features, functions, and services of multiple enterprise software solutions. Vendor responses are comprehensively rated on their level of support of for each criterion (supported, not supported, customization, future releases, etc.) to ensure you make and accurate and informed decision. This Software Evaluation Report provides extensive information about vendo Read More

The Sunshine Act: Compliance in Expense Reporting


The Sunshine Act has prompted life science companies to look at alternatives to their expense reporting processes. The output to HHS is required to be electronic, searchable, and easily downloaded. A solution that supports these requirements from the initial input step of the process provides proactive control and management of the data—and of the direct marketing process as a whole.

fda regulatory compliance reconsidered  Life Sciences,Biotechnology,Pharmaceutical,Legislation,Physician Payments Sunshine Provisions,Regulatory Compliance,Sunshine Act,Expense Manangement,Expense Reporting Read More

An Enterprise Approach to Sarbanes-Oxley Compliance


As is generally the case with such issues as the US Sarbanes-Oxley Act (SOX), the quick fix is often too good to be true. Leading companies are thus using SOX as an opportunity to restructure the way they run their business. What’s more, they’re finding they already have much of what they need—including the right people, processes, and technology.

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Enterprise Search for E-discovery Compliance


Enterprise search is rapidly emerging as a key component to electronic discovery, and is proving to be the very technology that organizations need to comply with US Federal Rules of Civil Procedure (FRCP). But not all enterprise search software is the same, and conducting a review of the various technologies available can be a daunting task. Find out what you’ll need to look for to ensure regulatory compliance.

fda regulatory compliance reconsidered  Search for E-discovery Compliance Enterprise search is rapidly emerging as a key component to electronic discovery, and is proving to be the very technology that organizations need to comply with US Federal Rules of Civil Procedure (FRCP). But not all enterprise search software is the same, and conducting a review of the various technologies available can be a daunting task. Find out what you’ll need to look for to ensure regulatory compliance. Read More

The Challenges of Defining and Managing Governance, Risk Management, and Compliance


A broader, more structured approach is needed to effectively manage governance, risk management, and compliance (GRC). Enterprises will then be better able to guide their people, standardize their processes, and unify technology to embed GRC at all organizational levels.

fda regulatory compliance reconsidered  recommended. For instance, the FDA regulations for drug manufacturers are not fixed targets. Thus, compliance is a key objective for any regulated drug manufacturing company, but the requirements to meet compliance are subjective based upon product, production processes, and (perhaps most important) every company's tolerance for risk. Regulatory risk is the risk of being found out of compliance, and if a company accepts very limited risk, its cost of compliance will logically be high. Conversely, with Read More

Ascending the Maturity Curve: Effective Management of Enterprise Risk and Compliance


The governance, risk, and compliance (GRC) concept remains as relevant as ever. In addition to the traditional goal of meeting compliance obligations, companies today see the investment in risk and compliance management as a means of aligning their risk and controls with broader strategic goals, building better relationships with stakeholders, and enhancing overall performance. Read this white paper for survey finding and interviews that suggest several action points.

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