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Regulatory and Compliance
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 requirement...
 

 dmr fda regulatory compliance


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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Regulatory and Compliance RFI/RFP Template

Design for Compliance, Management of Hazardous and Controlled Substances, Regulatory and Compliance Documentation, Managing Recyclables and Controlled Waste, Product Technology Get this template

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Regulatory and Compliance
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 requirement...

Documents related to » dmr fda regulatory compliance

Selecting Manufacturing ERP for ISO 26000 Compliance


This white paper discusses the compelling business reasons for industrial companies to pay close attention to ISO 26000 and the UN Global Compact. It also explores the different ways that enterprise software like enterprise resources planning (ERP) and enterprise asset management (EAM) can be leveraged to help document compliance with the various requirements of the ISO standard.

dmr fda regulatory compliance  IFS,software administrativo,crm,erp,call center,on demand,annual report,supply chain,asset management,itil,ias,bpm,edi,csr,sales force Read More

How to Meet Regulatory Log Requirements with NetIQ


Many of today’s regulations require that organizations retain, archive, and protect log data from systems, applications, and network devices, and that the log data be reviewed periodically. However, given the size and complexity of most enterprise environments, collecting and managing the sheer deluge of information is beyond the capabilities of human-based resources. Discover how NetIQ Security Manager can help.

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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...

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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.

dmr fda regulatory compliance  governance,risk,and compliance,compliance management systems,grc automation,enterprise grc,grc technologies,grc initiatives,and compliance technologies,and compliance automation,paperless document management software,inventory management software,document management software,digital asset management solutions,project management software 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.

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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.

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

dmr fda regulatory compliance  SumTotal,government,learning management,learning management software,learning management solution,learning management solutions,learning management system,learning management system lms,learning management systems,learning talent development 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.

dmr fda regulatory compliance  enterprise risk and compliance,risk and compliance management,risk and compliance management processes,riska nd compliance management failures,GRC Read More

Avoiding Information Overload: A Logical Approach to Managing Endpoint Security and Compliance


One of the biggest issues now facing corporations is regulatory compliance. As if corporate security threats weren’t enough, regulations such as Sarbanes-Oxley (SOX), the Gramm-Leach-Bliley Act (GLBA), and others now have long checklists of mandated requirements that must be adhered to—and thoroughly documented—by IT departments. Learn about a logical approach to managing the volumes of data required to prove compliance.

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Enhancing Governance, Risk, and Compliance through Effective Access Risk Management


Regardless of the size of the organization, embedding governance, risk, and compliance (GRC) management into all business process is imperative. But most organizations are reactive rather than proactive when it comes to undertaking a risk management initiative. Leading companies identify building a risk-aware culture as a key strategy. Read on to find out more about ways to enable effective access risk management.

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Managing Compliance with 21 CFR Part 11


Compliance with regulatory requirements is a business-critical need you must maintain. But meeting this need is more challenging with the creation of new regulations, such as 21 CFR Part 11, governing the use of software for secure data processing. But compliance is possible: an enterprise resource planning (ERP) system can help with audits, document and digital signatures, validation scripts, and other security needs.

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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.

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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.

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Why Google Docs Must Have Compliance Management


More than 30 million users within businesses, government agencies, schools and other organizations world-wide have switched to Google Apps. Unfortunately, Google Apps does not have any built-in document compliance or records management features to meet organizational standards and legal regulations. This document discusses how to achieve regulatory and policy compliance with Google Apps.

dmr fda regulatory compliance  Google Apps,Document Compliance,Compliance,Records Management,SaaS,Cloud Applications Read More