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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.
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 fda compliance digest


Sarbanes-Oxley Database Compliance
Under the US Sarbanes-Oxley Act, companies must maintain proven auditing practices and assure integrity and timeliness of data. Thus, companies must secure

fda compliance digest  Oxley Database Compliance Under the US Sarbanes-Oxley Act, companies must maintain proven auditing practices and assure integrity and timeliness of data. Thus, companies must secure systems that monitor corporate data. To effectively accomplish this, you are best off investing in a solution that can comprehensively cover your reporting and auditing needs while providing you the capacity to respond swiftly should any incidents occur.

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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 compliance digest

Paths out of the Compliance Quagmire: Plugging a Multibillion-dollar Hole


Preventable deductions are a major source of frustration and cost for suppliers, while the compliance violations that trigger them are likewise frustrating and costly for retailers. Eliminating the violations—and, thereby, eliminating the deductions—is in the best interests of both parties. Find out how a system that automates information handling processes, as well as compliance enforcement and monitoring, can help.

fda compliance digest  out of the Compliance Quagmire: Plugging a Multibillion-dollar Hole Preventable deductions are a major source of frustration and cost for suppliers, while the compliance violations that trigger them are likewise frustrating and costly for retailers. Eliminating the violations—and, thereby, eliminating the deductions—is in the best interests of both parties. Find out how a system that automates information handling processes, as well as compliance enforcement and monitoring, can help. Read More

IBM OpenPages Policy and Compliance Management


This video introduces the IBM OpenPages GRC Platform and, specifically, the Policy and Compliance Management module.

fda compliance digest  OpenPages Policy and Compliance Management 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.

fda compliance digest  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 Read More

Improving Regulatory Compliance with Encryption


As a bedrock element of any sound corporate data protection strategy, encryption protects valuable company data, whether it is at rest, in transit, or in use. Advanced encryption algorithms coupled with faster processors now make it possible to transparently encrypt and decrypt entire drive volumes, massive amounts of data on storage area networks (SANs), and other large-volume data stores.

fda compliance digest  Regulatory Compliance with Encryption As a bedrock element of any sound corporate data protection strategy, encryption protects valuable company data, whether it is at rest, in transit, or in use. Advanced encryption algorithms coupled with faster processors now make it possible to transparently encrypt and decrypt entire drive volumes, massive amounts of data on storage area networks (SANs), and other large-volume data stores. Read More

Compliance: Is Remote Office Data Your Achilles Heel?


Would spending millions of dollars and countless hours securing your data center be enough for it to pass a compliance audit? While many businesses work hard at securing their data centers, they often forget to secure remote office data. With the consequences of non-compliance ranging from financial penalties to job loss and worse, it could mean the end of your business. Don’t let compliance become your Achilles heel.

fda compliance digest  Is Remote Office Data Your Achilles Heel? Would spending millions of dollars and countless hours securing your data center be enough for it to pass a compliance audit? While many businesses work hard at securing their data centers, they often forget to secure remote office data. With the consequences of non-compliance ranging from financial penalties to job loss and worse, it could mean the end of your business. Don’t let compliance become your Achilles heel. Read More

Achieving Efficient Governance, Risk, and Compliance (GRC) through Process and Automation


Newly available software platforms known as governance, risk, and compliance (GRC) technologies can help your business stay on top of the myriad procedures, tasks, and behaviors that bear upon compliance. This paper discusses the drivers behind the growing awareness of GRC information technology, introduces the elements of an effective automated GRC system, and suggests a low-risk, high-impact approach to launching GRC automation.

fda compliance digest  Efficient Governance, Risk, and Compliance (GRC) through Process and Automation Newly available software platforms known as governance, risk, and compliance (GRC) technologies can help your business stay on top of the myriad procedures, tasks, and behaviors that bear upon compliance. This paper discusses the drivers behind the growing awareness of GRC information technology, introduces the elements of an effective automated GRC system, and suggests a low-risk, high-impact approach to launching Read More

Don’t Let Wireless Detour Your PCI Compliance


The Payment Card Industry Security Standards Council (PCI SSC) has published a PCI DSS Wireless Guideline which acknowledges that wireless is a clear and present danger to network security and those who collect, store or transmit card holder data must take steps to assure that it is secure, whether or not wireless is deployed in the cardholder data environment. Organizations that handle payment card data must take steps to secure the CDE against wireless threats including unmanaged and unknown wireless devices in the environment and must scan all locations. This white paper helps organizations understand how the PCI DSS 1.2 wireless requirements apply to them, how to meet those requirements in a cost effective way, and how to secure your network and cardholder data from wireless threats.

fda compliance digest  Let Wireless Detour Your PCI Compliance The Payment Card Industry Security Standards Council (PCI SSC) has published a PCI DSS Wireless Guideline which acknowledges that wireless is a clear and present danger to network security and those who collect, store or transmit card holder data must take steps to assure that it is secure, whether or not wireless is deployed in the cardholder data environment. Organizations that handle payment card data must take steps to secure the CDE against wireless 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 compliance digest  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. Read More

The Convergence of Enterprise Governance, Risk & Compliance Software Solutions


The market for governance, risk, and compliance is still a maelstrom. Some vendors offer GRC software for the enterprise (eGRC), whereas others offer GRC for monitoring access and communications for compliance (IT-GRC). What’s more—both branches of GRC use technology to automate highly complex processes, while some GRC vendors offer capabilities that overlap both areas. To get a sense of the current attitudes toward GRC, Hypatia Research evaluated more than 20 GRC software vendors and interviewed more than 660 users of these applications. Read up on best practices, benchmarks, and vendor ranking.

fda compliance digest  Convergence of Enterprise Governance, Risk & Compliance Software Solutions The market for governance, risk, and compliance is still a maelstrom. Some vendors offer GRC software for the enterprise (eGRC), whereas others offer GRC for monitoring access and communications for compliance (IT-GRC). What’s more—both branches of GRC use technology to automate highly complex processes, while some GRC vendors offer capabilities that overlap both areas. To get a sense of the current attitudes toward GRC, Read More

Aligning Financials for Improved Business Value and Compliance


In Align Financial Processes and Systems for Better Business Value and Compliance, learn how an integrated, life-cycle approach to financial manage...

fda compliance digest  Financials for Improved Business Value and Compliance If your company uses disparate software systems, spreadsheets, and manual workarounds to drive financial outcomes, you may be stifling your business. In Align Financial Processes and Systems for Better Business Value and Compliance , learn how an integrated, life-cycle approach to financial management can dramatically improve your financial analysis, performance, and reporting. You'll discover how the right financial approach can help you gain Read More

Validate and Enforce Change Process for SOX Compliance


If the auditors came knocking, would you be prepared? When they do come, you’ll need to be ready to answer some tough questions regarding your change management processes. Implementing and assessing change management controls for Sarbanes-Oxley Act (SOX) compliance in the US can be a very expensive and time consuming process. Find out how you can reduce the SOX burden by improving the way you manage your change processes.

fda compliance digest  and Enforce Change Process for SOX Compliance If the auditors came knocking, would you be prepared? When they do come, you’ll need to be ready to answer some tough questions regarding your change management processes. Implementing and assessing change management controls for Sarbanes-Oxley Act (SOX) compliance in the US can be a very expensive and time consuming process. Find out how you can reduce the SOX burden by improving the way you manage your change processes. Read More

Winning the PCI Compliance Battle


The payment card industry (PCI) Data Security Standard establishes common processes and precautions for handling credit card data. Although achieving PCI compliance can seem daunting, the requirements represent security best practices that should be observed by any organization with IT systems and data to protect. Learn about network scanning and security assessment solutions that can help you manage PCI compliance.

fda compliance digest  the PCI Compliance Battle Winning the PCI Compliance Battle If you receive errors when attempting to view this white paper, please install the latest version of Adobe Reader. Qualys® is headquartered in Redwood Shores, California, with offices in France, Germany, the U.K., Japan and Hong Kong, and has partners worldwide. Source : Qualys Resources Related to Payment Card Industry (PCI) : Payment Card Industry (PCI) (Wikipedia) Winning the PCI Compliance Battle PCI Compliance is also known as : Read More

Convergence, Collaboration, and Culture: The Evolution of Governance, Risk, and Compliance


Traditional governance, risk, and compliance (GRC) programs are siloed initiatives that are not equipped to manage the complexity of the dynamic modern regulatory and compliance environment. Organizations thus need to adopt a programmatic approach and tightly integrate risk management initiatives with ongoing business processes. BI and reporting can help, as well as provide a powerful mechanism for gaining a deep understanding of key factors that impact corporate performance.

fda compliance digest  Collaboration, and Culture: The Evolution of Governance, Risk, and Compliance Traditional governance, risk, and compliance (GRC) programs are siloed initiatives that are not equipped to manage the complexity of the dynamic modern regulatory and compliance environment. Organizations thus need to adopt a programmatic approach and tightly integrate risk management initiatives with ongoing business processes. BI and reporting can help, as well as provide a powerful mechanism for gaining a deep Read More

Governance, Risk, and Compliance for Life Sciences Companies: Institutionalize Compliance to Reduce Costs and Increase Productivity


Issues of governance, risk, and compliance (GRC) affect nearly everything life sciences companies do. But you shouldn’t approach GRC in an ad hoc manner—implementing point solutions one after another in response to regulatory demands as they arise. This is inefficient and costly—and may result in non-compliance, due to lack of transparency. Learn how an enterprise-wide GRC approach to compliance management can help.

fda compliance digest  Practices (cGxP) and the FDA's 21 CFR Part 11, which sets down requirements for establishing audit trails for electronic documents. To combat counterfeiting, companies must introduce electronic pedigree controls. The SAP GRC Access Control application ensures SOD compliance for cGMP between different areas of operation, for example, production and quality management. Powered by SAP NetWeaver, SAP solutions for GRC ease compliance with Part 11 requirements for documentation and auditability, while Read More