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Five Must-have ERP Features for Medical Device Manufacturers
In the medical device manufacturing industry, errors can cost more than money—they can cost lives. In order to meet safety regulations, manufacturers are

fda part 820  Medical Device Development | FDA Regulations 21 CFR 820 | Quality System Regulation | 21 CFR Part 11 | ISO 9001 | ISO 13485 2003 | Medical Device Software | SaaS Delivery Model for Medical Industry | Best ERP Software Systems | Medical Device Product Development | ERP Management System for Medical Manufacturers | Manufacturing Engineer Medical Device | Medical Device & Manufacturing | Medical Device Manufacturing News | ERP System for Medical Equipment Manufacturer | ERP Solutions for Medical Product Read More...
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Documents related to » fda part 820


The Best-kept Secret in the Product Lifecycle Management Mid-market
The name Omnify Software may hardly come to mind when one thinks of the product lifecycle management (PLM) leaders, but that might change down the track

fda part 820  the defense industry, while FDA compliance requirements are causing medical manufacturers to shy away from hosted solutions. Namely, these regulations call for adherence to specific processes and data sets when using automated or electronic systems. They also have an impact on how customers need to test and validate the software they use to help build their products. Unfortunately, these validation processes add yet another layer of complexity to SaaS systems since customers will need to go through a Read More...
Automotive Industry and Food, Safety, and Drug Regulations
Enterprise application providers wanting to address the distinct regulatory requirements of the automotive, food, safety, and life sciences industries need to

fda part 820  electronic signatures. This US FDA regulation establishes requirements for electronic records systems, thereby regulating the use of computer systems, audit trails, lot and serial traceability, change control, archiving, e-signatures, and security. As automation began to replace paper-based systems, the US Congress feared a loss of documented control over safe pharmaceutical production processes. With an initial focus on medical devices and life science products, Congress mandated a verifiable, traceable Read More...
Nimble Enterprise Applications Vendor Faces Stiff Challenges in A Competitive Environment
Despite intensifying competition in the enterprise applications market, IFS likes its chances. IFS has released the seventh generation of its component-based

fda part 820  When a manufacturer violates FDA rules, the consequences are serious and can include warning letters, mandatory product recalls, inability to ship product, and even criminal penalties for individual managers. SLiM meets or exceeds the current regulatory requirements for operating procedures, document control, training records, product traceability, and configuration management mandated by Title 21, Parts 11 and 820 of the US Code of Federal Regulations (CFR), and the Sarbanes-Oxley Act (SOX). Targeting Read More...
Is Epicor Poised to Rule the Mid-Market Retail Sector? (Part II)
Part I of this blog topic  introduced Epicor Software and its traditional vertical solutions. It also analyzed Epicor's forays into the attractive retail sector

fda part 820  Epicor Poised to Rule the Mid-Market Retail Sector? (Part II) Part I of this blog topic   introduced Epicor Software and its traditional vertical solutions. It also analyzed Epicor's forays into the attractive retail sector via the CRS acquisition two years ago. Designed for integration and scalability, the  Epicor/CRS Retail Suite can support a wide variety of retail enterprises' requirements. These environments range from the rapidly expanding regional retailer requiring point-of-sale (POS) , Read More...
ERP Selection Series: Requirements for an FDA-regulated Environment
The FDA imposes strict process controls on food and pharmaceutical manufacturers for good reason. Consequences of mistakes are hefty—ranging from costly recalls

fda part 820  an FDA-regulated Environment The FDA imposes strict process controls on food and pharmaceutical manufacturers for good reason. Consequences of mistakes are hefty—ranging from costly recalls and lawsuits to illness and death. Food and pharmaceutical manufacturers need to keep profitability high while maintaining strict quality-control standards. See how your ERP software can make the difference between process control and business-crippling process instability. Read More...
To SaaS or Not, Is That a Question? - SaaSy Discussions (Part IIb)
The first part (Part II) of this blog series described the opportunities for software as a service (SaaS) or on-demand applications, especially in the current

fda part 820  SaaS or Not, Is That a Question? - SaaSy Discussions (Part IIb) The first part (Part II) of this blog series  described the opportunities for software as a service (SaaS ) or on-demand  applications, especially in the current difficult economic milieu. Part IIa then analyzed the  top five SaaS assumptions (misconceptions) recently outlined by  Gartner . Before any vendor can embark onto delivering a SaaS offering, it must thoroughly consider a number of harrowing SaaS technology choices and their Read More...
The Wizardry of Business Process Management: Part 5
Part 1 of this blog series started a lengthy discussion about the value proposition and parts-and-parcels of business process management (BPM), with an ensuing

fda part 820  Wizardry of Business Process Management: Part 5 Part 1 of this blog series  started a lengthy discussion about the value proposition and parts-and-parcels of  business process management (BPM ), with an ensuing focus on  Pegasystems (also known as Pega ) as one of the leading BPM suite providers.  Part 2 ,  Part 3 , and  Part 4  then analyzed in depth a number of the vendor’s “BPM secret sauce” ingredients. Pega is one of the leading vendors in the overall BPM software market (it has been Read More...
A Tale of a Few Good SCM Players - Part 4
Part 1 of this blog post series followed the genesis of Manhattan Associates from its inception in 1990 throughout the mid-2000s. During this time, Manhattan

fda part 820  Tale of a Few Good SCM Players - Part 4 Part 1 of this blog post series  followed the genesis of  Manhattan Associates  from its inception in 1990 throughout the mid-2000s. During this time, Manhattan Associates was the epitome of an impeccable  supply chain management (SCM)  software company in terms of market share, growth, profitability, and its product capabilities. Indeed, the company set the industry standard for the supply chain execution (SCE) space and was the envy of its competitors. But Read More...
They do it like that in the Balkans-Select and deploy ERP, I mean (Part II)
The Part I of this blog topic concluded with SAP's supremacy in the upper-end of the regional market. What also helps SAP ERP [evaluate this product] is a

fda part 820  do it like that in the Balkans-Select and deploy ERP, I mean (Part II) The Part I of this blog topic concluded with SAP 's supremacy in the upper-end of the regional market . What also helps SAP ERP [ evaluate this product ] is a number of well-established value added resellers (VARs) that cover the entire former Yugoslavia region, some of which have a few dozen renowned installation sites (customer references) and a roster of experienced consultants. Some of these are the earlier mentioned S&T Group Read More...
The Magic Behind Planning and Executing (Optimal) Service Supply Chains - Part 1
The recent three-part series entitled “Navigating Between Service Management Scylla @ Charybdis” analyzed the phenomenon of service economy, or the

fda part 820  Magic Behind Planning and Executing (Optimal) Service Supply Chains - Part 1 The recent three-part series entitled “Navigating Between Service Management Scylla & Charybdis” analyzed the phenomenon of  service economy , or the increasing importance of the service sector  in industrialized economies. But while the vast  customer service  software market’s opportunity was examined there, the series also pointed out the treacherous complexity of planning and executing service supply chains. Read More...
How Some ERP Vendors Demonstrated - Warts And All Part 2: Results
This is part two of a case study from a recent selection engagement for an ETO mid-size manufacturer; we assess Oracle, J.D. Edwards, SAP, and IFS in terms of

fda part 820  Some ERP Vendors Demonstrated - Warts And All Part 2: Results How Some ERP Vendors Demonstrated - Warts And All Overview  The subject of this case study is the synopsis of a crucial step within every software selection process - finalist vendors' scripted scenarios software demonstrations; this particular series of events took place in February/March 2001. The importance of this milestone in any software selection undertaking has been widely publicized (for more information, see An Overview of the Read More...
Intel Faces 820 Chipset Problems (Again)
In the latest round of setbacks to beset Intel’s performance-oriented 820 chipset, the manufacturer announces a recall of nearly a million motherboards shipped

fda part 820  toshiba laptop pc,buy laptop,toshiba laptop u400,laptop pc cheap,computers cheap,netbooks toshiba,cheap hd dvd,buy pc,buy notebook,buy computers,toshiba notebook a300,quosimo laptop,buy laptop computers,toshiba laptops a300,toshiba pc Read More...
Frankie Does ERP, Part 1
[Editor’s note: Frank is not a composite character. He is a real person, employed at a real company. I’ve changed certain identifying particulars at his request

fda part 820  Does ERP, Part 1 [Editor’s note: Frank is not a composite character. He is a real person, employed at a real company. I’ve changed certain identifying particulars at his request. This interactive series, created and published with his permission, is an exercise in what-if analysis based on interviews I am currently conducting with him. You may find Frank’s use of language a little colorful. I have toned it down. It's still colorful.] * My name is Frank. I’m a mid-level manager for a Read More...
Outsourcing Security Part 3: Selecting a Managed Security Services Provider
As the final article in a three-part series on outsourcing security, the following article provides guidelines for selecting a dependable managed security

fda part 820  Security Part 3: Selecting a Managed Security Services Provider Introduction It's the middle of the night. A shadowed figure crouches by the window. He retrieves a menacing instrument and begins fiddling with the lock. But the intruder won't get far: the homeowners have contracted a security provider to monitor a tight alarm system-or so they thought. Actually, the security company has recently gone out of business and failed to notify its customers. As the intruder makes his way into the Read More...

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