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 fda guideline


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 guideline  , FDA Compliant , FDA Guideline , FDA Guidelines , FDA Label Compliance , FDA Medical Device Compliance , FDA Regulatory Compliance , FDA Requirements , Food and Drug Administration FDA , Medical Regulatory Compliance , Regulatory Compliance , Regulatory Compliance Software , FDA Policy , FDA Compliance Consulting . While every manufacturer in the United States is subject to a multitude of governmental rules and regulations, probably no industries are as fully regulated as those dealing with

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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

Documents related to » fda guideline

Ability 585 ERP Is Now TEC Certified


In a recent live demo session with enterprise resource planning (ERP) software vendor Ability, I had the chance to get an in-depth look at Ability 585 ERP. It’s not every day that a product’s capabilities exceed my expectations, but this was the certainly the case with Ability 585 ERP, which is now TEC Certified for ERP for Manufacturing (SMB). Ability’s core principle is to provide

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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?

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QAD Explore 2012: Only Good Things Can Come from Talking to the Customer


As a seasoned provider of enterprise applications for manufacturing companies, QAD knows the importance of listening to its clients. In fact, the company has created a customer engagement program to help its customers align their business processes to their strategic business goals. Get the details on this program, as well as a full update from the QAD Explore 2012 user conference in P.J. Jakovljevic’s latest article.

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Oracle Renders Its PLM Outline Part One: Event Summary


Although its PLM solutions will not likely be the "all things to all people" any time soon, Oracle might be showing us its ability to develop its own applications in collaborative effort with its prominent customers.

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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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Mid-market ERP Vendors Leveraging (and Occasionally Outdoing) Microsoft’s “Plumbing” - Part 2


Part 1 of this blog series analyzed Epicor and SYSPRO, the two renowned enterprise resource planning (ERP) mid-market incumbents that heavily harness Microsoft’s platform tools. To that end, the business productivity tools that were illustrated in my recent blog post on what 2010 might have meant to Microsoft’s business solutions (which reflected on the highly publicized mid

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Summarizing PTC’s Decades of Fervent In-House Innovation (and Acquisitions) - Part 3


Part 1 of this blog series introduced Needham, Massachusetts (US)-based Parametric Technology Corporation (PTC, NASDAQ: PMTC), which is an over US$1-billion large software company that develops, markets, and supports product development software solutions and related services. My post analyzed the company’s genesis from its inception in 1985 through the mid 2000s. Part 2 then analyzed the most

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QAD Ready for Life Sciences Manufacturing Needs


Life sciences manufacturing has been a hot vertical for QAD, both in terms of upgrading existing customers to the cloud and winning brand new cloud enterprise resource planning (ERP) customers. QAD has developed a solution for medical device manufacturers to help meet the unique device identifier (UDI) rules as required by the Food and Drug Administration (FDA), and Facet Technologies has recently deployed QAD Cloue ERP.

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Inconso WMS Suite


"As much standard as possible - only as much individuality as required." This is the guideline for the conception of inconso's software solutions. The inconsoWMS product suite covers solution requirements from modest manual warehouses up to complex distribution centers with high throughput and/or full automation levels. The full integration of any subsystem (such as radio data transmission [RF], barcoding, radio frequency identification [RFID], pick-by-voice, pick-by-light, material flow calculation, and weighing systems) is realized with standard connectors and permits a solution concept coordinated with the respective requirements. Complexity and throughput are the parameters that decide which product is used for what situation. The inconsoWMS Standard is conceived for manual or radio data transmission (RF)-led applications and is used in smaller and midsized distribution centers. These are typically so-called crossdocking and public warehouses, where several clients are dealt with in a single distribution center. The inconsoWMS eXtended solution is a standard solution for complex and high performance applications. It is mainly used in highly automated distribution centers and at logistics service providers in the area of dedicated warehouse systems.  

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From Farm to Fork: The Need for Traceability in the Food Chain


Traceability and visibility in the global food supply chain is crucial to farmers and food processors, in light of recent major food recalls. Manufacturers need to tightly manage their production quality, even into the suppliers’ operations, to comply with FDA requirements. ERP solutions, like Plex Online, enable food manufacturers to track every ingredient in every product at least one-up and one-back in their supply chains.

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