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Software Functionality Revealed in Detail
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 erp 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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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 » erp fda regulatory compliance

ERP Issues for the Midsized Life Sciences Company


What makes your enterprise resource planning (ERP) requirements difficult for most vendors to satisfy? As a life sciences company, you have operational processes that set you apart from other manufacturing companies. And, your regulatory requirements, including 21 CFR part 11, aren’t like those of any other industry. The challenge is to manage compliance risks and compliance costs. Learn about an ERP compliance strategy.

erp fda regulatory compliance  all areas of the ERP system that are FDA significant, including batch records, engineering changes, quality records, inventory status transactions, process instructions and recording of results. The infrastructure approach gives the business control over its approach to compliance. For example, a hard-coded compliance solution might require an electronic signature when signing off on a data entry to a batch record, even if the business keeps a paper batch record. The Merit solution infrastructure 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.

erp fda regulatory compliance  unicode-enabled) should help user enterprises manage and standardize trade compliance processes throughout the entire organization. The software should automatically screen business partners against official sanctioned party lists, check for embargo restrictions, and manage export and import licenses. Further, GTM applications should expedite customs processes by facilitating interactions between the user enterprise and customs agencies, driving more efficient movement of goods and information across Read More

The Challenges of Defining and Managing Governance, Risk Management, and Compliance


A broader, more structured approach is needed to effectively manage governance, risk management, and compliance (GRC). Enterprises will then be better able to guide their people, standardize their processes, and unify technology to embed GRC at all organizational levels.

erp fda regulatory compliance  reason enough to motivate enterprises to be more vigilant in their business practices, enterprises can in fact capitalize on the regulations they face. Companies should view compliance as a way to improve their internal business processes across the organization. To do this, companies must take a holistic approach from top down, and harness the strategic software category of governance, risk management, and compliance (GRC). However, this may be easier said than done. So why might a holistic approach to Read More

How a Leading Vendor Embraces Governance, Risk Management, and Compliance


SAP AG has long committed to placing compliance at the core of its product suite, as the vendor has recognized the growing role of enterprise systems in assisting companies to meet the increasing challenges of corporate compliance and risk management.

erp fda regulatory compliance  core component of mySAP ERP , it contains functions for data analysis and reporting, as well as financial and risk management. The solution also ensures that all financial processes comply with the US Sarbanes-Oxley Act (SOX) requirements. Another component that has been serving some complex compliance requirements (such as EH&S) very well is master data management (MDM). This is especially true in light of globally dispersed supply chains, but the need for product quality, specifications consistency, Read More

Sage 100 Standard ERP (v. 4.5) for Mixed-mode Manufacturing ERP Certification Report


Sage 100 Standard ERP (formerly Sage ERP MAS 90), v. 4.5, is TEC Certified for online evaluation of mixed-mode manufacturing enterprise resource planning (ERP) solutions in the ERP Evaluation Center. The certification seal is a valuable indicator for organizations relying on the integrity of TEC research for assistance with their software selection projects. Download this report for product highlights, competitive analysis, product analysis, and in-depth analyst commentary.

erp fda regulatory compliance  100 Standard ERP (v. 4.5) for Mixed-mode Manufacturing ERP Certification Report Sage 100 Standard ERP (formerly Sage ERP MAS 90), v. 4.5, is TEC Certified for online evaluation of mixed-mode manufacturing enterprise resource planning (ERP) solutions in the ERP Evaluation Center. The certification seal is a valuable indicator for organizations relying on the integrity of TEC research for assistance with their software selection projects. Download this report for product highlights, competitive Read More

Epicor ERP Software System (v. 9.05) for Distributors ERP Certification Report


Epicor ERP Software System (v. 9.05) is now TEC Certified for online evaluation of enterprise resource planning (ERP) solutions for distributors in the ERP Evaluation Center. The certification seal is a valuable indicator for organizations relying on the integrity of TEC research for assistance with their software selection projects. Download this report for product highlights, competitive analysis, product analysis, and in-depth analyst commentary.

erp fda regulatory compliance  ERP Software System (v. 9.05) for Distributors ERP Certification Report Epicor ERP Software System (v. 9.05) is now TEC Certified for online evaluation of enterprise resource planning (ERP) solutions for distributors in the ERP Evaluation Center. The certification seal is a valuable indicator for organizations relying on the integrity of TEC research for assistance with their software selection projects. Download this report for product highlights, competitive analysis, product analysis, and in-depth Read More

Sage ERP X3 v.6 for Distribution Enterprise Resource Planning Certification Report


Sage ERP X3 v.6 is now TEC Certified for online evaluation of enterprise resource planning (ERP) solutions for distribution in the ERP Evaluation Center. The certification seal is a valuable indicator for organizations relying on the integrity of TEC research for assistance with their software selection projects. Download this report for product highlights, competitive analysis, product analysis, and in-depth analyst commentary.

erp fda regulatory compliance  ERP X3 v.6 for Distribution Enterprise Resource Planning Certification Report Sage ERP X3 v.6 is now TEC Certified for online evaluation of enterprise resource planning (ERP) solutions for distribution in the ERP Evaluation Center. The certification seal is a valuable indicator for organizations relying on the integrity of TEC research for assistance with their software selection projects. Download this report for product highlights, competitive analysis, product analysis, and in-depth analyst Read More

Sage 500 ERP for Process Manufacturing ERP Certification Report


Sage 500 ERP (formerly Sage ERP MAS 500) is TEC Certified for online evaluation of process manufacturing enterprise resource planning (ERP) solutions in the Process Manufacturing ERP Evaluation Center. The certification seal is a valuable indicator for organizations relying on the integrity of TEC research for assistance with their software selection projects. Download this report for product highlights, competitive analysis, product analysis, and in-depth analyst commentary.

erp fda regulatory compliance  500 ERP for Process Manufacturing ERP Certification Report Sage 500 ERP (formerly Sage ERP MAS 500) is TEC Certified for online evaluation of process manufacturing enterprise resource planning (ERP) solutions in the Process Manufacturing ERP Evaluation Center. The certification seal is a valuable indicator for organizations relying on the integrity of TEC research for assistance with their software selection projects. Download this report for product highlights, competitive analysis, product analysis, Read More

10 Steps to Continuous Compliance: Putting in Place an Enterprise-wide Compliance Strategy


Understanding the full scope of risk in today’s complex business environment is a must for achieving compliance with governmental mandates and industry regulations. However, many companies have a limited perception of risk and struggle to make compliance an enterprise-wide, integrated process. Compliance is no longer a one-time isolated project; it’s an ongoing effort—and you’re just tens steps away from discovering why.

erp fda regulatory compliance  Putting in Place an Enterprise-wide Compliance Strategy 10 Steps to Continuous Compliance: Putting in Place an Enterprise-wide Compliance Strategy If you receive errors when attempting to view this white paper, please install the latest version of Adobe Reader. Founded in 2002 and based in San Jose, CA, LogLogic is an innovator and market leader in log management, compliance management and security management solutions designed to improve accountability and lower costs for organizations of all Read More

ERP: Justifying the Cost


Many benefits accrue from deploying an enterprise resource planning (ERP) system. Many of these are tangible or quantifiable in nature; you can calculate the savings immediately. However, other benefits may not be quantified so easily, but they are also important. This whitepaper looks at both tangible and intangible benefits of deploying an ERP solution and attempts to give you good justification for the costs involved.

erp fda regulatory compliance  benefits of deploying an ERP solution and attempts to give you good justification for the costs involved. Read More

Don’t Forget to Factor In Mobile ERP When Selecting a New ERP System


A 2011 study of mid-market manufacturers sought to understand the nature of demand for mobile access to enterprise resource planning (ERP) and other enterprise software. This study surveyed over 200 executives, all of whom reported involvement in software selection at manufacturing companies with more than $100 million (USD) in revenue. Read this article to learn about the current state of mobile ERP for mid-market manufacturers.

erp fda regulatory compliance  to Factor In Mobile ERP When Selecting a New ERP System With the proliferation of smartphones, tablet computers, and other mobile computing devices—and the associated increase in applications designed for them—the obvious question is when users of enterprise solutions including enterprise resource planning (ERP) will be able to access company-wide solutions from their mobile devices in meaningful ways. In mid-2011, as IFS prepared for the release of IFS Touch Apps , its mobile ERP initiative, IFS Read More

IFS Applications (v. 7.5) for Discrete Manufacturing ERP Certification Report


IFS Applications (v. 7.5) is TEC Certified for online evaluation of discrete manufacturing enterprise resource planning (ERP) solutions in the ERP Evaluation Center. The certification seal is a valuable indicator for organizations relying on the integrity of TEC research for assistance with their software selection projects. Download this report for product highlights, competitive analysis, product analysis, and in-depth analyst commentary.

erp fda regulatory compliance  7.5) for Discrete Manufacturing ERP Certification Report IFS Applications (v. 7.5) is TEC Certified for online evaluation of discrete manufacturing enterprise resource planning (ERP) solutions in the ERP Evaluation Center. The certification seal is a valuable indicator for organizations relying on the integrity of TEC research for assistance with their software selection projects. Download this report for product highlights, competitive analysis, product analysis, and in-depth analyst commentary. Read More

The Path to ERP for Small Businesses, Part 3: Selection of ERP Software


The third and final part of the path to ERP for small businesses series describes the software selection stage, including the dos and don’ts during vendor product demos, how to create a shortlist, and finally selecting the vendor that provides the best product and services for your needs.

erp fda regulatory compliance  Path to ERP for Small Businesses, Part 3: Selection of ERP Software Parts 1 and 2 of this series described the processes of research and evaluation of enterprise resource planning (ERP) software. At the end of these two stages, you should have a pretty good idea which type of software might fit the needs of your organization and which vendors might provide this solution. Part 3 will describe the final stage—selecting the software that best fits your specific needs. You started by defining the main Read More