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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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 fda compliance software erp


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 software erp  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 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). 

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Documents related to » fda compliance software erp

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.

fda compliance software erp  compliance. Compliance Strategy The FDA regulations are not a fixed target. Compliance is a key objective for any regulated company, but the requirements to meet this objective are subjective, based upon product, production processes and, perhaps most importantly, your tolerance for risk. Regulatory risk is the risk of being found out of compliance. If you accept very limited risk, your cost of compliance will be high. With more risk, compliance cost is reduced but the potential cost of non-compliance 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 software erp  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

Catching Up with Omnify Software


In the deluge of news revolving mainly around the Big Five product lifecycle management (PLM) vendors, i.e., Siemens PLM, Dassault Systemes, Parametric Technology Corporation (PTC), Oracle Agile PLM, and SAP PLM, hardly any noise comes from smaller PLM providers in the lower end of the market. To be certain, many smaller PLM players, who had been catering to the mid-market, such as former

fda compliance software erp  it be for the FDA, ISO, or FAA, etc., and they all need a way to meet the requirements as well as ease the compliance and audit processes. Because regulatory compliance typically requires tracking/traceability and reporting of product related data, PLM provides a very good foundation to manage this. PJ : What is your collaborative E2.0/social tools strategy? Any views on Dassault's Exalead acquisition? CC : We continue to encompass more social media concepts into our tool suite. Our current focus is to Read More

Complying with US FDA Title 21 CFR Part 11 for the Life Sciences Industry


Compliance with US FDA regulations is a market requirement. Thus, among the nearly 1,500 installations of mySAP ERP software among pharmaceutical, medical diagnostics and devices, and biotechnology companies worldwide, it is vital to be aware of the functions and features of mySAP ERP that demonstrate technical compliance with US FDA 21 CFR Part 11 Electronic Records; Electronic Signatures; Final Rule.

fda compliance software erp  with US FDA Title 21 CFR Part 11 for the Life Sciences Industry Compliance with US FDA regulations is a market requirement. Thus, among the nearly 1,500 installations of mySAP ERP software among pharmaceutical, medical diagnostics and devices, and biotechnology companies worldwide, it is vital to be aware of the functions and features of mySAP ERP that demonstrate technical compliance with US FDA 21 CFR Part 11 Electronic Records; Electronic Signatures; Final Rule. Read More

Sage 300 ERP 6.0 Certification Report (ERP for Distribution)


Sage 300 ERP (formerly Sage ERP Accpac) 6.0 is 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.

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Infor LN


Infor ERP LN has a single code base for all platforms and supports integration with external systems, including the supply chain and the Web, using industry-standard technology. The solution supports processes from make-to-stock (MTS) to engineer-to-order (ETO), and cost-cutting techniques like flow line and lean manufacturing. This cross-industry solution offers functionality for enterprises in discrete and project-based manufacturing industries, such as industrial machinery and equipment, high-tech and electronics, aerospace and defense, and automotive. Infor Open Architecture, the service-oriented architecture on which Infor ERP LN is built, helps users create bridges with their supply chains through standards-based, loosely coupled integration (J2EE, SOAP, and WDSL) and complete support for Web services.

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Enterprise Software Selection Guide


Selecting an enterprise software solution takes time, energy, and resources. During the selection process, vendors present their products and services in the best possible light, leaving you to separate real functionality from marketing hype. In this guide, you’ll discover a three-phase methodology for objectively researching, evaluating, and selecting the best software solutions for your company.

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Justification of ERP Investments Part Three: Costs of Implementing an ERP System


Enterprise resource planning (ERP) implementation costs can be divided into one-time costs and ongoing annual costs. Both types of costs can be segmented into hardware, software, external assistance, and internal personnel. Reprinted from Maximizing Your ERP System by Dr. Scott Hamilton.

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ERP Trivia - Every Why Should Have Its Wherefore Part 1: ERP Trends


We take the liberty to comment on the findings of a report, which was recently released by a renowned research organization, and which pinpoints ERP implementations’ dissatisfactions in no uncertain terms.

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Sage ERP X3 (v. 6) for Mixed-Mode Manufacturing ERP Certification Report


Sage ERP X3 (v. 6) 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.

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Sage 100 Standard ERP (v. 4.5) for Discrete Manufacturing ERP Certification Report


Sage 100 Standard ERP (formerly Sage ERP MAS 90), v. 4.5, 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.

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ERP System21


The Infor ERP System21 Workspace recognizes that the employee is often the most important factor in business process performance. The workspace is designed to provide a simple, user-friendly working environment, which completely integrates individual employees with the essential processes of their organization.  

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Cezanne Software


Cézanne Software provides human capital planning (HCM) and management software, and develops and designs solutions that enable organizations to better plan and optimize the human side of their business. The company’s focus is to provide the business owner with people-centered solutions to manage the execution and evolution of business processes that are critical for the organization's success. The privately held company's North American headquarters are in Boston, Massachusetts (US). Cézanne Software is a global software vendor with more than 300 company clients in Europe, North America, Latin America, and West Africa.

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