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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.
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 dmr controls fda 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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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 controls fda compliance

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.

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Implementing Basel II in the Compliance Continuum


Banks can benefit enormously from understanding the various stages of the Basel II compliance program, as identified by i-flex. Banks today are discovering problems as they stumble along the path to compliance. However, if they can benchmark themselves on which stage they fall in along the continuum, and buckle themselves for the challenges that lie ahead, they will have greater success towards Basel II compliance, and enjoy the benefits of maintaining reduced capital.

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GreenSky: A Solution for Aviation Emissions Reporting and Compliance to EU-ETS


‘GreenSky’ is an end-to-end Carbon Emissions Reporting and Compliance solution for Aviation that covers all aspects of the European Union’s mandate on the Emissions Trading System (EU ETS). With an integrated approach of automated monitoring, reporting, and pre-verification, the solution is a comprehensive framework that offers a rapid deployment methodology for airlines to achieve the most effective means of compliance.

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A Quality and Compliance Training Road Map for Emerging FDA-regulated Companies


A Quality and Compliance Training Road Map for Emerging FDA-Regulated Companies Emerging life science companies face the same compliance and regulatory pressures as larger ones. Companies that outsource sales and operational functions need to disseminate training on key policies, procedures, and regulations to a wide audience—without the benefit of a dedicated training team. These companies demand solutions that automate the quality training effort without compromising the entire quality program.

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Segregation of Duties and Its Role in Sarbanes-Oxley Compliance Issues


The Sarbanes-Oxley Act (SOX) requires publicly traded firms to demonstrate that their accounting and reporting practices are in compliance with regulatory standards. Section 404 of SOX addresses the concept and practice of segregation of duties—a key aspect of this legislation, and the focus of this article.

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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.

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ERP Selection Series: Requirements for an FDA-regulated Environment


The FDA imposes strict process controls on food and pharmaceutical manufacturers for good reason. Consequences of mistakes are hefty—ranging from costly recalls and lawsuits to illness and death. Food and pharmaceutical manufacturers need to keep profitability high while maintaining strict quality-control standards. See how your ERP software can make the difference between process control and business-crippling process instability.

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Compliance Exposures in ERP Systems Part 1


This paper examines key issues for CFOs and CEOs in managing ERP systems in the new world of SOX, IFRS, Basle II. While most IT management attention seems to be on document retention, reporting quality, and security, there are broader issues to be considered toward ensuring good governance and compliance with regulations such as Sarbanes-Oxley, IFRS and Basle II.

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Sarbanes-Oxley Compliance with ERP Software


For many companies, enterprise resource planning (ERP) is the single most important infrastructure element, thanks largely to its power in delivering end-to-end integration. New technology in ERP software has grown in sophistication over the years, enabling even further automation of business functions. Find out how you can leverage one ERP solution to deal with one of your biggest bugbears: Sarbanes-Oxley compliance.

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Guide to Tax Collection Compliance: Ending the Nightmare


In mid-market report: the changing face of sales and use tax compliance, find out just how bad the problem has become, and what midsized companies ...

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