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Documents related to » fda medical device compliance plm


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 MEDICAL DEVICE COMPLIANCE PLM:
1/7/2008 5:27:00 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 MEDICAL DEVICE COMPLIANCE PLM:
12/11/2006 2:32:00 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 MEDICAL DEVICE COMPLIANCE PLM:
6/19/2009 3:21:00 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 MEDICAL DEVICE COMPLIANCE PLM:
10/12/2007 5:21:00 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 MEDICAL DEVICE COMPLIANCE PLM:
2/12/2007 2:54:00 PM

How a Leading Vendor Embraces Governance, Risk Management, and Compliance
SAP AG has long committed to placing compliance at the core of its product suite, as the vendor has recognized the growing role of enterprise systems in assisting companies to meet the increasing challenges of corporate compliance and risk management.

FDA MEDICAL DEVICE COMPLIANCE PLM: Food and Drug Administration (FDA) requirements for pharmaceutical companies; and Basel II for the banking sector. This is part one of the two-part article How a Leading Vendor Embraces Governance, Risk Management, and Compliance . In part two, SAP s GRC product suite will be discussed in more detail, and speculation will be made on the product suite s potential for success within the vendor s current and prospective customer base.
5/2/2007

Managing Performance, Risk, and Compliance for Better Business Results
Managing performance, risk, and compliance for better business results. Maximize strategic, financial, and operational effectiveness. Confronted by globalization and volatile markets, today’s companies face a challenging and often risky business climate. Explore how to ensure alignment between your company's strategic objectives and risk management/compliance policies; how to mitigate all types of business risk and maintain a proper risk/reward balance; and how to ensure continuous compliance with regulatory requirements and internal policies.

FDA MEDICAL DEVICE COMPLIANCE PLM: SAP, management risk, risk management, management of risk, regulatory compliance, enterprise risk management, financial risk management, risk financial management, risk insurance management, risk management insurance, risk management jobs, credit risk management, managing risk, risk credit management, risk management plan, risk management software, insurance and risk management, operational risk management, strategic objectives, risk managment, security risk management, business risk management, information risk management, it risk management, regulatory compliance software, risk management .
3/2/2010 10:34:00 AM

Compliance and Privileged Password Management
Today’s increasing compliance requirements have focused additional attention on how enterprises manage and control these critical accounts and passwords. How can you address the requirement for shared privileged access while still maximizing information security? Find out how traditional solutions may not be providing the security you need—and how upgrading your password system with an automated solution can help.

FDA MEDICAL DEVICE COMPLIANCE PLM:
6/4/2008 3:32:00 PM

Governance, Risk, and Compliance for Life Sciences Companies: Institutionalize Compliance to Reduce Costs and Increase Productivity
Governance, Risk, and Compliance for Life Sciences Companies: Institutionalize Compliance to Reduce Costs and Increase Productivity. Find RFP Templates to Define Your Systems Implementation In Relation To Governance, Risk, and Compliance. 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 MEDICAL DEVICE COMPLIANCE PLM: 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
6/4/2009 12:15:00 PM

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 MEDICAL DEVICE COMPLIANCE PLM: Life Sciences, Biotechnology, Pharmaceutical, Legislation, Physician Payments Sunshine Provisions, Regulatory Compliance, Sunshine Act, Expense Manangement, Expense Reporting.
9/19/2011 1:02:00 PM

Avoiding Costly Fines: A 2011 Guide to Compliance Mandates
It’s up to human resources (HR) to ensure that hiring, discipline, and termination practices are compliant with the law. Otherwise, you could put your company at risk of incurring fines, penalties, and employee lawsuits. Find out all about the latest workforce compliance and safety laws and regulations that may affect your organization so you can train management and employees, and avoid expensive employee lawsuits.

FDA MEDICAL DEVICE COMPLIANCE PLM: Sage, cobra, ada, fica, osha, hipaa, fmla, sarbanes-oxley, erisa, futa, flsa, hrms, regulatory compliance, hipaa compliance, hipaa laws, hipaa law, regulatory compliance software, hipaa violations, erisa plan, erisa law, fmla law, futa tax, hipaa violation, ada law, hipaa requirements, hipaa notice, osha violations, consumer credit protection act, erisa plans, fmla laws, osha fines, erisa regulations, federal osha, erisa employee, fmla requirements, osha reporting, erisa requirements, fmla benefits, fmla notice, fmla rules.
11/11/2010 3:31:00 PM


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