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Documents related to » fda compliance program guidance manual


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 PROGRAM GUIDANCE MANUAL: 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

Profiting from PCI Compliance
Although the Payment Card Industry Data Security Standard (PCI DSS) has become a global requirement, many organizations are lagging in compliance. For many companies, regulatory compliance can already be an overwhelming and confusing area to navigate, and the need to comply with the PCI DSS might feel like yet another burden. Discover the efficiency gains of building a strategy designed around PCI compliance.

FDA COMPLIANCE PROGRAM GUIDANCE MANUAL: Profiting from PCI Compliance Profiting from PCI Compliance Source: IBM Document Type: White Paper Description: Although the Payment Card Industry Data Security Standard (PCI DSS) has become a global requirement, many organizations are lagging in compliance. For many companies, regulatory compliance can already be an overwhelming and confusing area to navigate, and the need to comply with the PCI DSS might feel like yet another burden. Discover the efficiency gains of building a strategy designed around
4/9/2010 12:30:00 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 PROGRAM GUIDANCE MANUAL: 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

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 PROGRAM GUIDANCE MANUAL: 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

Moving from Paper to Electronic Records: Hardwiring Compliance into Product Development
Medical device manufacturers face the usual manufacturing challenges, with the added burden of having to plan, develop, test, and produce in an environment controlled by strict regulatory requirements. With paper-based systems, product lifecycle documentation adds a huge burden to an already colossal task. Find out how you can “hardwire” compliance into product development—without short-circuiting your business processes.

FDA COMPLIANCE PROGRAM GUIDANCE MANUAL: Moving from Paper to Electronic Records: Hardwiring Compliance into Product Development Moving from Paper to Electronic Records: Hardwiring Compliance into Product Development Source: PTC Document Type: White Paper Description: Medical device manufacturers face the usual manufacturing challenges, with the added burden of having to plan, develop, test, and produce in an environment controlled by strict regulatory requirements. With paper-based systems, product lifecycle documentation adds a huge burden to
10/10/2007 4:03:00 PM

Are You on Track for 21 CFR Part 203 Compliance?
It’s old, it’s new, and it’s the future. Pedigree tracking regulations were originally passed into law through the Prescription Drug Marketing Act of 1987 (PDMA). After two decades of postponing enforcement, the US Food and Drug Administration (FDA) has lifted its final stay. Pharmaceutical companies are expected to be in compliance with 21 CFR Part 203 by the year 2011. Do you have what it takes for compliance?

FDA COMPLIANCE PROGRAM GUIDANCE MANUAL: Food and Drug Administration (FDA) has lifted its final stay. Pharmaceutical companies are expected to be in compliance with 21 CFR Part 203 by the year 2011. Do you have what it takes for compliance? Are You on Track for 21 CFR Part 203 Compliance? style= border-width:0px; />   comments powered by Disqus Related Topics:   Enterprise Resource Planning (ERP),   Process Manufacturing,   Material Management,   Regulatory and Compliance Related Industries:   Miscellaneous Manufacturing Source:
8/18/2008 3:16:00 PM

Governance, Regulation and Compliance
Companies must meet GRC criteria defined by internal and external policies, as failing to do so can have business and legal consequences. Although management of travel and entertainment (T&E) expenses is often seen as being of low importance for overall GRC, poorly managed T&E can lead to unforeseen issues with long-term business impact. See why using an external T&E management provider is the best way to adhere to GRC.

FDA COMPLIANCE PROGRAM GUIDANCE MANUAL: Governance, Regulation and Compliance Governance, Regulation and Compliance Source: Quocirca Ltd Document Type: White Paper Description: Companies must meet GRC criteria defined by internal and external policies, as failing to do so can have business and legal consequences. Although management of travel and entertainment (T&E) expenses is often seen as being of low importance for overall GRC, poorly managed T&E can lead to unforeseen issues with long-term business impact. See why using an external T&E
1/25/2011 12:25:00 PM

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 finesand lawsuits. Download this white paper to find out how a learning management compliance solution can help manage your compliance requirements.

FDA COMPLIANCE PROGRAM GUIDANCE MANUAL: The Value of a Learning Management Compliance Solution The Value of a Learning Management Compliance Solution Source: SumTotal Systems Document Type: White Paper Description: 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
7/6/2011 7:43:00 PM

Updating and Streamlining Compliance Training Across a Network of Hospitals
Exempla Healthcare was facing several business challenges, including achieving 100% compliance on annual required training, establishing consistency and content standardization among hospitals, and reducing student time spent in training. The company selected ToolBook®, along with SumTotal Learning Management, to create, deliver, and track training using one integrated system. Read the case study and see the benefits.

FDA COMPLIANCE PROGRAM GUIDANCE MANUAL: Updating and Streamlining Compliance Training Across a Network of Hospitals Updating and Streamlining Compliance Training Across a Network of Hospitals Source: SumTotal Systems Document Type: Case Study Description: Exempla Healthcare was facing several business challenges, including achieving 100% compliance on annual required training, establishing consistency and content standardization among hospitals, and reducing student time spent in training. The company selected ToolBook®, along with SumTotal
5/27/2011 4:18:00 PM

Intrusion Prevention Solutions Enable Sarbanes-Oxley Compliance
IT departments play a key role in complying with the US Sarbanes-Oxley Act (SOX). Without the right technological solutions to record and monitor access to networks, financial systems, and sensitive data, company management cannot ensure the integrity of the information in their financial reports. That’s why technology that helps with SOX compliance and internal control management is imperative.

FDA COMPLIANCE PROGRAM GUIDANCE MANUAL: Intrusion Prevention Solutions Enable Sarbanes-Oxley Compliance Intrusion Prevention Solutions Enable Sarbanes-Oxley Compliance Source: Top Layer Networks Document Type: White Paper Description: IT departments play a key role in complying with the US Sarbanes-Oxley Act (SOX). Without the right technological solutions to record and monitor access to networks, financial systems, and sensitive data, company management cannot ensure the integrity of the information in their financial reports. That’s why
4/12/2007 10:42:00 AM

Identity-based NAC and PCI Data Security Compliance
As of June 2006, the payment card industry (PCI) has established a detailed set of policy, procedure, infrastructure, and data security requirements for merchants that store and process credit card data. That’s why it’s vital for key PCI requirements to be met when it comes to encryption, user authentication, virus and malware control, access control, and auditing.

FDA COMPLIANCE PROGRAM GUIDANCE MANUAL: Identity-based NAC and PCI Data Security Compliance Identity-based NAC and PCI Data Security Compliance Source: Caymas Systems Document Type: White Paper Description: As of June 2006, the payment card industry (PCI) has established a detailed set of policy, procedure, infrastructure, and data security requirements for merchants that store and process credit card data. That’s why it’s vital for key PCI requirements to be met when it comes to encryption, user authentication, virus and malware control,
2/13/2007 4:08:00 PM


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