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Documents related to » fda compliance guidance medical


PCI Compliance Cost Analysis
The Payment Card Industry Data Security Standard (PCI-DSS) was created by credit card companies to protect cardholder data, ensuring that merchants and service providers maintain the highest degree of information security. However, many retailers are still questioning its effectiveness and necessity in light of the high cost of compliance. Read this white paper to find out what this cost really means for your organization.

FDA COMPLIANCE GUIDANCE MEDICAL: PCI Compliance Cost Analysis PCI Compliance Cost Analysis Source: Solidcore Systems, Inc. Document Type: White Paper Description: The Payment Card Industry Data Security Standard (PCI-DSS) was created by credit card companies to protect cardholder data, ensuring that merchants and service providers maintain the highest degree of information security. However, many retailers are still questioning its effectiveness and necessity in light of the high cost of compliance. Read this white paper to find out what
1/7/2008 5:27:00 PM

Compliance: A Work in Progress
There’s no magic bullet for compliance success—even the most experienced organizations use a combination of reliable processes and proven technologies to get the job done. But identifying, designing, and executing the right internal controls to meet compliance standards in a large, global company can be arduous and expensive. The systems you use to support compliance efforts must be implemented well. Find out more.

FDA COMPLIANCE GUIDANCE MEDICAL: Compliance: A Work in Progress Compliance: A Work in Progress Source: SAP Document Type: White Paper Description: There’s no magic bullet for compliance success—even the most experienced organizations use a combination of reliable processes and proven technologies to get the job done. But identifying, designing, and executing the right internal controls to meet compliance standards in a large, global company can be arduous and expensive. The systems you use to support compliance efforts must be
6/19/2009 3:21:00 PM

ITAR Compliance with SAP GTS
If you deal in goods, services, or intellectual property included in the US Munitions List, you must ensure that all related transactions conform to International Traffic in Arms Regulations (ITAR). To answer this challenge, you need a solution that automates core ITAR processes—a solution that stores all your licenses and related documents where you can keep tabs on them.

FDA COMPLIANCE GUIDANCE MEDICAL: ITAR Compliance with SAP GTS ITAR Compliance with SAP GTS Source: SAP Document Type: White Paper Description: If you deal in goods, services, or intellectual property included in the US Munitions List, you must ensure that all related transactions conform to International Traffic in Arms Regulations (ITAR). To answer this challenge, you need a solution that automates core ITAR processes—a solution that stores all your licenses and related documents where you can keep tabs on them. ITAR Compliance with
12/11/2006 2:32:00 PM

LogRhythm and SOX Compliance
In order for a business to stay on top of compliance requirements required by the Sarbanes-Oxley Act (SOX)—and avoid financial penalties or possible jail time—it must take a good look at its IT environment and financial reporting processes. The collection, management, and analysis of log data are integral to meeting SOX requirements and as such, require a system that automates these processes across the IT infrastructure.

FDA COMPLIANCE GUIDANCE MEDICAL: LogRhythm and SOX Compliance LogRhythm and SOX Compliance Source: LogRhythm Document Type: White Paper Description: In order for a business to stay on top of compliance requirements required by the Sarbanes-Oxley Act (SOX)—and avoid financial penalties or possible jail time—it must take a good look at its IT environment and financial reporting processes. The collection, management, and analysis of log data are integral to meeting SOX requirements and as such, require a system that automates these
10/12/2007 5:21:00 PM

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 COMPLIANCE GUIDANCE MEDICAL: 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 mor
3/9/2007

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 GUIDANCE MEDICAL: Compliance: Is Remote Office Data Your Achilles Heel? Compliance: Is Remote Office Data Your Achilles Heel? Source: Asigra Document Type: White Paper Description: 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
10/25/2007 3:39:00 PM

Privileged User Monitoring for SOX Compliance
Many companies face the Sarbanes-Oxley (SOX) compliance challenge of monitoring all the data activity of their most privileged users. Those challenges include tracking access to sensitive financial data, reporting on controls, and responding to problems. Learn about a database auditing and protection solution that can help capture targeted activities, without impacting the performance of production databases and software.

FDA COMPLIANCE GUIDANCE MEDICAL: Privileged User Monitoring for SOX Compliance Privileged User Monitoring for SOX Compliance Source: Tizor Document Type: White Paper Description: Many companies face the Sarbanes-Oxley (SOX) compliance challenge of monitoring all the data activity of their most privileged users. Those challenges include tracking access to sensitive financial data, reporting on controls, and responding to problems. Learn about a database auditing and protection solution that can help capture targeted activities, without
3/14/2008 5:39:00 PM

President Proposes Security of Medical Records
President Clinton has announced plans to ensure the privacy of patient medical records. This initiative will prove to be extremely expensive, and will pose a number of technology challenges. How can vendors get a piece of the pie? Who will administer the security of such a large infrastructure development and what products will be used? What organization is best positioned to evaluate the products such a project may require?

FDA COMPLIANCE GUIDANCE MEDICAL: President Proposes Security of Medical Records President Proposes Security of Medical Records L. Taylor - November 2, 1999 Read Comments Event Summary On Friday, October 29th, President Clinton proposed that national standards be developed to ensure the privacy of patient medical records. Citing instances in which employers have reviewed medical records of prospective employees without notifying the employee, the President said that With the click of a mouse, personal health information can easily, and
11/2/1999

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.

FDA COMPLIANCE GUIDANCE MEDICAL: Proactive IT Triage for Sarbanes-Oxley Compliance Proactive IT Triage for Sarbanes-Oxley Compliance Source: eG Innovations, Inc. Document Type: White Paper Description: 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
3/26/2007 2:00:00 PM

Retailer-centric Planning: Compliance to Collaboration
In a game where the goals don’t change, but the rules do, winners and losers are determined by how well each team sees the big picture. Thus, suppliers who understand and support retailers’ goals have a better likelihood of success. The greater the alignment of processes and communication between suppliers and retailers, the greater the chances of a big win.

FDA COMPLIANCE GUIDANCE MEDICAL: Retailer-centric Planning: Compliance to Collaboration Retailer-centric Planning: Compliance to Collaboration Source: Prescient Document Type: White Paper Description: In a game where the goals don’t change, but the rules do, winners and losers are determined by how well each team sees the big picture. Thus, suppliers who understand and support retailers’ goals have a better likelihood of success. The greater the alignment of processes and communication between suppliers and retailers, the greater the
2/12/2007 2:54:00 PM

A Consolidated Archive Storage Array for Compliance and Retention
Reliance on enterprise data is growing at exponential rates. And thanks to internal processes and legal requirements, the period of time that data must be retained is increasing—as is the cost of retaining the data itself. As storage needs grow, the cost of deploying siloed storage systems is becoming unmanageable. Find out how consolidating resources can translate into bottom-line savings for your enterprise.

FDA COMPLIANCE GUIDANCE MEDICAL: A Consolidated Archive Storage Array for Compliance and Retention A Consolidated Archive Storage Array for Compliance and Retention Source: Pillar Data Systems Document Type: White Paper Description: Reliance on enterprise data is growing at exponential rates. And thanks to internal processes and legal requirements, the period of time that data must be retained is increasing—as is the cost of retaining the data itself. As storage needs grow, the cost of deploying siloed storage systems is becoming
8/15/2008 3:59:00 PM


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