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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

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.

dmr fda regulatory assistance  Healthcare IT,ICD-10,morbidity and mortality reporting,ICD-10 compliance Read More

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.

dmr fda regulatory assistance  reporting,QAD,compliance,operations,disclosure Read More

10 Critical Factors to control and configuration management (CCM) Success


Is your IT environment suffering? Increasing complexity and the challenges of achieving regulatory compliance within a tight budget could be making it more difficult for you to manage change. A traditional change and configuration management (CCM) tool might not be providing all the help you need. Find out how a CCM tool that addresses configuration audit and control can ease your IT infrastructure’s aches and pains.

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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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Not Just Words: Enforce Your E-mail and Web Acceptable Usage Policies


Unmanaged employee use of e-mail and the Web can subject your organization to costly risks including litigation, regulatory investigations, and public embarrassment. Responsible organizations should deploy clearly written acceptable usage policies (AUPs) for e-mail and Web usage, supported by employee training and enforced by technology solutions. Find out how to develop and enforce e-mail and Web AUPs in your workplace.

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Implementing Detailed User-level Auditing of UNIX and Linux Systems


UNIX and Linux systems aren’t exempt from the rigors of regulatory compliance. System logs can help you spot suspicious insider activity and contribute to more accurate compliance reports by showing which users accessed what systems, what commands they executed, and what changes they made to key files and data. Find out how centralized UNIX/Linux auditing can help you troubleshoot and reduce your risk of non-compliance.

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Privileged User Management


IT managers feel overwhelmed with the rising tide of security threats they have to deal with in the face of an increasing regulatory burden. But they tend to overlook one particular area of IT security—the privileged access that they grant themselves or their colleagues in order to do their jobs. Learn how to make sure your IT systems are not impacted by the inadvertent or malicious actions of privileged users.

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What Small Businesses Need to Know in Today’s Regulatory Environment


Today, entrepreneurs running small-to-medium sized businesses face daunting tasks that just a few years ago were not existent. The complexities of the business world have created new risks, a myriad of regulations, and complex reporting requirements that can overwhelm any organization. Owners and managers of all enterprises, even smaller private businesses, need to be cognizant of both the spirit and the letter of the law. How does a smaller organization, with limited resources, cope with all of this? How do they stay abreast of the additional changes that are on the way? In this guide, Pete Russo of the Entrepreneurial Management Institute at the Boston University School of Management outlines the pitfalls and steps, but also looks at effective solutions for private companies.

dmr fda regulatory assistance  Small Businesses Need to Know in Today’s Regulatory Environment Source: SAP Resources Related to What Small Businesses Need to Know in Today's Regulatory Environment : Sarbanes–Oxley Act(SOX) (Wikipedia) What Small Businesses Need to Know in Today's Regulatory Environment Sarbanes-Oxley Compliance Software is also known as : Software Solution , Particular Software Solution , Enterprise Software Solution , Inflexible Software Solution , Business Software Solutions , Software Solution Provider , Read More

How Is Regulatory Stress-testing Shaping the Future for Banks?


Out of the shortcomings exposed in banks’ traditional risk management processes during the recent global financial crisis comes the critical need for improvement. One particular high-profile risk management requirement is enterprise stress-testing, and it is subject to additional regulatory burdens and wider scrutiny. Stress-testing is moving the banking industry into more involved and invasive analysis. Find out how.

dmr fda regulatory assistance  stress-testing, risk management, Comprehensive Capital Analysis and Review requirement, CCAR requirement, regulatory stress-testing, dynamic balance stress-testing, bank regulatory compliance Read More

Drug Pedigree Guidelines and How Software Can Help


Drug manufacturers and retailers are tightening their data collection and reporting processes to meet new US Food and Drug Administration (USFDA) guidelines. But which software offerings are best placed to help drug manufacturers comply with the new guidelines?

dmr fda regulatory assistance  drug manufacturers,US Food and Drug Administration,FDA,pharmaceutical,FDA pedigree guidelines,pharmaceutical manufacturers,drug distributors,drug wholesaler,drug retailer,enterprise resource planning,ERP,warehousing data,distribution center,electronic data interchange,EDI 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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Simplifying Secure File Transfer: Selecting a Best-in-class File Transfer Management Solution


Corporations share data with a variety of remote offices, trading partners, customers, and regulatory agencies. Sensitive data is transferred to and from entities around the world billions of times a day. Security breaches are frequently in the news, with reports of compromised customer data. However, business-to-business (B2B) workflow breakdowns are more likely to occur—and are potentially just as harmful.

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Health Means More


Medical and health care regulatory norms are tightening worldwide, and all key stakeholders, including payers, providers, and patients are becoming more discerning with regard to the quality of products and services delivered. As a result, the health care and life sciences (HLS) sector is increasingly leaning on analytics to find solutions for improving the delivery of health care—and improving the business of health care.

dmr fda regulatory assistance  healthcare,analytics,data management,Medicine and healthcare,life sciences Read More

Microsoft Axapta for Life Sciences


Executives in the life sciences industry work under tremendous competitive pressures. At the same time, they must meet regulatory guidelines and ensure that product safety remains a priority. Information must be meticulously tracked through all phases of a production cycle, which can slow production significantly. That’s why solutions for the industry must help streamline and simplify the regulatory compliance process.

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