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Software Functionality Revealed in Detail
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 dmr fda regulatory assistance


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 regulatory assistance

6 Metrics No Executive Should Be Without


In an economic climate characterized by cost-cutting and increased regulatory requirements, organizations face growing demands to reduce employee turnover and cut unnecessary costs across the board. For chief executives and financial business leaders, that means moving away from soft measurements and adopting quantifiable metrics to monitor the overall business. Detailed metrics can help companies more effectively utilize their HR data to make fact-based decisions about their human capital investments. This paper highlights some of the most valuable strategic metrics that BI tools can deliver to CFOs and executives.

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ICD-10: Business Transformation through Regulatory Compliance


The International Classification of Diseases (ICD) has had structural and space limitations that constrained its ability to accommodate advances in medical knowledge and technology. ICD-10 codes address these issues and also help in morbidity and mortality reporting. Information technology (IT) systems and infrastructure used by US health care stakeholders must be ICD-10 compliant by October 1, 2013, as mandated by the Department of Health and Human Services. This paper discusses an ICD-10 migration approach and its impacts on payer/provider processes, as well as the business benefits of early adoption.

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Making Training More Precise through Task-based Competency Assessments


Many FDA-regulated companies need to assess how their personnel demonstrate competency for assigned functions. This paper explores how an automated competency assessment can be embedded into the process training, so that follow-up actions, such as the assignment of additional training or initiating a remedial mentoring program, happen automatically. This leads to more precise training and more accurate, audit-ready records.

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Differentiate Through Quality Using Exceptional Issue Management


Increase the quality of your goods and services, and watch customer satisfaction, regulatory compliance, and business success soar. Whether you sell goods or deliver services, high quality can be a differentiator for your business. A focus on quality lets partners and customers know that you care about serving them efficiently, solving problems, and earning their loyalty. Read this paper to learn about a quality issue management application to help you quickly identify, monitor, and analyze quality issues.

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Tenrox


Since 1995, Tenrox has provided on-demand software solutions for enterprise fragmentation, work projects, and regulatory scrutiny. Tenrox's solutions, with Statement on Auditing Standards (SAS) 70 Type II certification, focus on best practices and work policies, regulatory compliance, and real-time reporting. The company has served over 800 organizations in 50 countries, including Blue Cross Blue Shield, First National Bank, Hydro-Québec, The Pentagon, and Wyeth. Tenrox is based in Pasadena, California (US), and has offices in Montreal and Toronto (Canada), and London (UK).

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Effective Operational Security Metrics


Due to the changing regulatory environment and the complexity of business today, organizations are facing increased accountability. Security risks, however, can often be difficult to measure and even more difficult to understand by people outside of the department. The key to demonstrating improvement is to translate security information in to business terms. Organizations must align, manage, and measure security around business operations.

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Inovis MESH Framework for Dial Tone Business Communities


When it comes to business-to-business (B2B) communications, two of the basic requirements for regulatory compliance are having a reliable network and a high quality dial tone. So why would you want to settle for anything less? To ensure that both are obtained, many companies are entrusting their data—and their compliance responsibilities—to the Inovis Multienterprise Expert Services Hub (MESH) platform. Find out why.

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Automotive Industry and Food, Safety, and Drug Regulations


Enterprise application providers wanting to address the distinct regulatory requirements of the automotive, food, safety, and life sciences industries need to offer enterprises industry-oriented enterprise resource planning systems that are sound and compliance-ready.

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The Sarbanes-Oxley Act and International Financial Reporting Standards


Recent legislation has bought about unparalleled emphasis on corporate governance and regulatory compliance. In the United States, the Enron and Worldcom affairs have led to a new law Sarbannes-Oxley. In Europe, the EU parliament has decided that all countries must streamline the laws for financial reporting in accordance with IFRS rules from IASC. Bringing organizations into compliance with new demands for corporate governance is having immediate and long-term effects. In this paper we discuss the current business environment, those facets of legislation impacting manufacturers and how QAD enterprise suite of applications can assist you in achieving corporate governance and regulatory compliance quickly, efficiently, and cost-effectively.

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Twenty Successful eMentoring and eLearning Strategies in Healthcare for Increasing Revenue, Decreasing Expenses, and Eliminating Regulatory Consequences


Every core business process and strategic initiative requires a human capital management (HMC) business strategy for execution; improvements made in HCM systems and processes can notably impact an organization’s bottom line. Mentoring programs and other models for integrating work and learning are exciting avenues for stimulating professional growth, career development, staff morale, and quality of care within the workplace.

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