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 dmr fda compliance expectations


Medical Device Manufacturers Can Leverage ERP/CRM Software to Facilitate FDA Compliance
The US Food and Drug Administration (FDA) requires pharmaceuticals and medical device companies to comply with numerous standards. Medical device manufacturers

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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 » dmr fda compliance expectations

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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IBM OpenPages Policy and Compliance Management


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

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Controlling Access Risk: Increase Visibility, Reduce the Time and Cost of Compliance


Managing end-user access to critical enterprise resources as part of an organization's IT governance, risk management, and compliance (GRC) initiative helps companies to control access risk, provide real-time visibility for multiple stakeholders, and streamline regulatory compliance. This research shows that the leading performers in controlling access risk also realize tangible financial benefits.

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Make Compliance Work for You


Compliance is often treated as a necessary evil that creates costs, disruption, and complexity. But these pains often result from dealing with compliance in a clumsy way due to a lack of resources and the absence of a compliance strategy. There’s a better way: using standards-based data management solutions that integrate with existing infrastructure and leverage automation to embed compliance at all levels. Find out how.

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Provia Tackles RFID in a Twofold Manner Part Two: RFID Compliance


Provia's approach to radio frequency identification (RFID) compliance was to offer a bolt-on or drop-in product that works in conjunction with a company's existing logistics transactional software solution and process flows. This should put the suppliers back into control of prioritizing their IT projects because they could supposedly thereby be fairly easily and quickly made compliant with Wal-Mart or the DoD requirements for RFID. The next step for them would then be to look at how they can reap the benefits of RFID internally within their own operations.

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10 Steps to Continuous Compliance: Putting in Place an Enterprise-wide Compliance Strategy


Understanding the full scope of risk in today’s complex business environment is a must for achieving compliance with governmental mandates and industry regulations. However, many companies have a limited perception of risk and struggle to make compliance an enterprise-wide, integrated process. Compliance is no longer a one-time isolated project; it’s an ongoing effort—and you’re just tens steps away from discovering why.

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Enhancing Governance, Risk, and Compliance through Effective Risk Management


Embedding governance, risk, and compliance (GRC) management into all business process has become imperative. Companies need to adopt a holistic view when it comes to reducing and managing risks, and ensure better access risk management. This paper discusses the need for companies to take a proactive approach towards access risk management.

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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.

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Compliance Tips for Outbound Debt Collection Communications


The largest challenge to successful debt collection efforts today is outbound communications compliance. There are many rules to follow, and requirements are continually evolving.

This white paper looks at some key considerations for collection compliance for outbound communications. These include understanding the compliance landscape in the United States, complying with legal requirements and restrictions to avoid fines, and learning the best practices for obtaining debtor consent for collection communications.

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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.

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