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Software Functionality Revealed in Detail
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 fda compliance programs


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

fda compliance programs  ERP/CRM Software to Facilitate FDA Compliance Medical Device Manufacturers Can Leverage ERP/CRM Software to Facilitate FDA Compliance If you receive errors when attempting to view this white paper, please install the latest version of Adobe Reader. With more than 30 years' history and as one of the first software vendors to develop an enterprise resource planning (ERP) solution, SYSPRO is the longest standing and largest independent, international vendor of enterprise business solutions. Source :

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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 » fda compliance programs

Has Consolidation Made the PLM Market More Agile?


While the race for the pole position in the still evolving, moving-target PLM market started several years ago, it has been quite accelerated by Agile Software's fourth acquisition in 2003. Particularly with the most recent Agile-Eigner announcement, the two players have apparently decided to leapfrog many direct competitors by joining complementary forces.

fda compliance programs  compliance, such as satisfying FDA requirements for closed-loop, corrective action/preventative action (CAPA) management and Compliance with FDA Title 21 CFR Part 11, which prescribes the accepted use of electronic records and signatures. The agileMD solution entails: Agile's PLM solution for managing the medical device product record from research and development, clinical trials, regulatory approval, new product introduction (NPI), market acceptance, to product phase-out. Medical device best practices Read More

Global Trade and the Role of Governance, Risk Management, and Compliance Software


The growing number of legal and regulatory requirements associated with global trading is one of many reasons enterprises are looking into global trade management applications, and into harnessing the up-and-coming, strategic software category of governance, risk management, and compliance.

fda compliance programs  incarceration of executives (see FDA Compliance For The Life Sciences ). As another example, implementing and ensuring compliance with employee safety guidelines, monitoring emissions (which are often delineated by regulatory permits), and even validating the origin and composition of chemical products are all mission-critical processes that contribute to the cost of doing business. In other words, as explained in So, What's the Big Deal with Chemicals? , a new complexity that comes from some process Read More

Market Insight: Strategies for Overcoming Compliance Issues in the Pharmaceutical Industry


To successfully meet compliance demands, pharmaceutical manufacturers must develop, implement, and track the effectiveness of a company-wide compliance strategy. Key to that strategy is to adopt industry-specific enterprise software with functionality that supports Federal Drug Administration (FDA) requirements. Learn more about the criteria and recommendations you need to achieve compliance in the pharmaceutical industry.

fda compliance programs  Compliance Mistakes | Deacom FDA Compliance | Deacom Compliance Plan | Deacom Inc Compliance Issues | Deacom Approach to Compliance | Deacom Achieving Compliance | Deacom Compliance Demands | Deacom Compliance Objectives | Deacom Compliance Regulations | Level of Compliance Deacom Inc | Deacom Inc FDA Compliance Needs | Deacom GMP Compliance | Deacom Reaching Compliance | Compliance Strategy Deacom | Compliance Strategies Deacom | Strategies for Compliance Deacom | Strategies for Overcoming Compliancy Read More

Fighting Terrorism with Global Trade Management


The challenge for government and industry is to secure trade without impeding growth. Therefore, there is a greater need for timely information updated by knowledgeable sources of compliance and regulation issues. Global trade management software appears to be the best solution.

fda compliance programs  to be made to FDA within four hours; and prior notice of food import shipments before allowed entry to the US Patriot Act of 2002 This Act, signed into law by the US president, requires that financial institutions know their customers and, to the greatest extent possible, their customers' customers. (Source: TradeBeam ) One should notice a multitude of complex interactions between the global trade flows within a secure supply chain. Namely, across few dozens of required pertinent processes, global trade Read More

Regulatory and Compliance Software Evaluation Report


The Regulatory and Compliance Knowledge Base covers the requirements for ensuring products and their associated materials comply with both external and intenal rules and regulations. It covers regulatory and requirements needs, as well as product related components of Environmental Health and Safety (EH&S).

fda compliance programs  and Compliance Software Evaluation Report TEC's Regulatory and Compliance Software Evaluation Report allows you to compare and analyze the features, functions, and services of multiple enterprise software solutions. Vendor responses are comprehensively rated on their level of support of for each criterion (supported, not supported, customization, future releases, etc.) to ensure you make and accurate and informed decision. This Software Evaluation Report provides extensive information about vendo Read More

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 ...

fda compliance programs  to Tax Collection Compliance: Ending the Nightmare What a mess! the chief financial officer (CFO) exclaimed, lamenting his midsized company's losing effort to comply with sales and use tax requirements. Keeping on top of dozens of shifting tax regulations for scores of products in hundreds of jurisdictions has become an ongoing 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 like yours can Read More

Proactive IT Triage for Sarbanes-Oxley Compliance


When it comes to Sarbanes-Oxley compliance, most IT organizations do not lack measurement data—in fact, they’re buried in it! What they need are effective ways to put these measurements into the context of critical business services, establish baselines for every layer of every component, and proactively communicate which layer of which component is the root cause of any abnormality.

fda compliance programs  IT Triage for Sarbanes-Oxley Compliance When it comes to Sarbanes-Oxley compliance, most IT organizations do not lack measurement data—in fact, they’re buried in it! What they need are effective ways to put these measurements into the context of critical business services, establish baselines for every layer of every component, and proactively communicate which layer of which component is the root cause of any abnormality. Read More

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...

fda compliance programs  Financials for Improved Business Value and Compliance If your company uses disparate software systems, spreadsheets, and manual workarounds to drive financial outcomes, you may be stifling your business. In Align Financial Processes and Systems for Better Business Value and Compliance , learn how an integrated, life-cycle approach to financial management can dramatically improve your financial analysis, performance, and reporting. You'll discover how the right financial approach can help you gain Read More

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.

fda compliance programs  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 Read More

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.

fda compliance programs  Exposures in ERP Systems Part 1 Compliance Exposures in ERP Systems, Part 1 If you receive errors when attempting to view this white paper, please install the latest version of Adobe Reader. Founded in 2003, West Trax provides in-depth consulting services to large and mid-size national and international enterprises. Using its extensive subject matter expertise combined with proprietary tools and methodologies it aims to transform the value derived from clients? ERP investments. The company is Read More

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.

fda compliance programs  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. Read More

Enterprise Search for E-discovery Compliance


Enterprise search is rapidly emerging as a key component to electronic discovery, and is proving to be the very technology that organizations need to comply with US Federal Rules of Civil Procedure (FRCP). But not all enterprise search software is the same, and conducting a review of the various technologies available can be a daunting task. Find out what you’ll need to look for to ensure regulatory compliance.

fda compliance programs  Search for E-discovery Compliance Enterprise search is rapidly emerging as a key component to electronic discovery, and is proving to be the very technology that organizations need to comply with US Federal Rules of Civil Procedure (FRCP). But not all enterprise search software is the same, and conducting a review of the various technologies available can be a daunting task. Find out what you’ll need to look for to ensure regulatory compliance. Read More

LogRhythm and SOX Compliance


In order for a business to stay on top of compliance requirements required by the Sarbanes-Oxley Act (SOX)—and avoid financial penalties or possible jail time—it must take a good look at its IT environment and financial reporting processes. The collection, management, and analysis of log data are integral to meeting SOX requirements and as such, require a system that automates these processes across the IT infrastructure.

fda compliance programs  and SOX Compliance In order for a business to stay on top of compliance requirements required by the Sarbanes-Oxley Act (SOX)—and avoid financial penalties or possible jail time—it must take a good look at its IT environment and financial reporting processes. The collection, management, and analysis of log data are integral to meeting SOX requirements and as such, require a system that automates these processes across the IT infrastructure. Read More

SciQuest Introduces New Supplier Risk Compliance Module


The latest version of SciQuest’s cloud-based spend management automation suite introduces a new Dynamic Qualification and Risk Compliance module for Total Supplier Manager (TSM) that helps customers enhance supplier management capabilities.

fda compliance programs  Introduces New Supplier Risk Compliance Module The latest version of SciQuest ’s cloud-based spend management automation suite introduces a new Dynamic Qualification and Risk Compliance module for Total Supplier Manager (TSM) that helps customers enhance supplier management capabilities. This new module allows for a more thorough supplier vetting process, enabling customers to further qualify suppliers by collecting risk-based information and assess vendor status or compliance. Other new Read More