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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 Read More...
Discrete Manufacturing (ERP)
The simplified definition of enterprise resource planning (ERP) software is a set of applications that automate finance and human resources departments and help manufacturers handle jobs such as or...
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Documents related to » fda guideline


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

fda guideline  Guidelines? Simply stated, the FDA's pedigree guidelines require data to be captured at each stage of the production and distribution process, until the drugs reach the customer or end user. The players principally affected by the guidelines are pharmaceutical manufacturers, drug distribution companies, drug wholesalers, and drug retailers. From the manufacturer's perspective, the guidelines essentially require pharmaceutical companies to maintain data on each case of drugs leaving the shipping dock. Read More...
Oracle Renders Its PLM Outline Part One: Event Summary
Although its PLM solutions will not likely be the

fda guideline  Food and Drug Administration's [FDA] 21 CFR Part 11 regulation), Health Insurance Patient Portability Act (HIPAA), a guideline for managing patient information, and Sarbanes-Oxley Act (SOA), the new legislation for accounting procedures, while the Oracle Financials suite also now leverages eXtensible Business Reporting Language (XBRL), and XML-based standard for financial reporting. Also, rather than traditionally delivering a horizontally broad and functional product and relying on its technically savvy Read More...
Single Version of the Truth
Today's enterprise is no longer a single, vertically integrated organization. Globalization, outsourcing, and off-shoring have created an environment where end

fda guideline  food and drug administration (FDA) compliance, counterfeit issues—what's in it for me! Market forces—consumer acceptance and requirement for product level validation in terms of counterfeit and other threats—real implementations with proven return on investment (ROI) Education—an understanding of what is possible and what is available Maturity of solutions, more commercial offerings Simplicity of adoption—inclusion of existing components Global supply chains—community compliance Read More...
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

fda guideline  Food and Drug Administration (FDA), 21 CFR Part 11, International Financial Reporting Standards (IFRS) At the Roadmap phase, QAD’s team present a detailed plan for the deployment of the agreed-upon set of recommendations for a detailed work plan, resource requirements, change management control processes, and knowledge transfer. The implementation starts with QAD Easy On Boarding (EOB)— which follows industry best practices and QAD’s expert knowledge of implementing ERP solutions with preconfigured Read More...
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

fda guideline  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. *This is Part Three of a four-part article reprinted from Maximizing Your ERP System by Dr. Scott Hamilton. Bridging the theory and realities of current ERP systems, Maximizing Your ERP System provides Read More...
Making Gramm-Leach-Bliley Security Compliance Fast and Easy
Designed to improve consumer financial services, the Gramm-Leach-Bliley Act (GLBA) includes security provisions for protecting confidential electronic financial

fda guideline  Gramm-Leach-Bliley Security Compliance Fast and Easy Making Gramm-Leach-Bliley Security Compliance Fast & Easy If you receive errors when attempting to view this white paper, please install the latest version of Adobe Reader. Qualys® is headquartered in Redwood Shores, California, with offices in France, Germany, the U.K., Japan and Hong Kong, and has partners worldwide. Source : Qualys Resources Related to Security Compliance : Regulatory Compliance (Wikipedia) Making Gramm-Leach-Bliley Read More...
Infor Updates Automotive Supply Chain Collaboration Solutions
Infor recently announced the release of Infor Automotive Exchange v11.0 and Infor Supplier Exchange v11.3, two products that deliver embedded industry-required

fda guideline   Read More...
Not Yet Sold on SaaS ERP in Manufacturing? Take a Hard Look at Plex Online - Part 2
Part 1 of this blog series explained Plex Systems’ ebullience and growth despite a hostile and depressed environment, especially in the discrete manufacturing

fda guideline  There has been no FDA guidance issued on SaaS yet. Other issues and caveats would stem from the dubious validation of software that is outside the manufacturer’s physical control in spite of the additional power and accessibility of a SaaS system. SaaS applications must be built with full redundancy, backup, and failover so that the risk of data loss is reduced to as close to zero as possible. To that end, Plex is happy to submit itself to the customer’s qualification of it as an approved vendor. Read More...
QAD Raises the Blended Cloud/On-premise ERP Bar
QAD is a leading provider of enterprise applications for several thousand global manufacturing companies specializing in automotive, consumer products

fda guideline  worked with a US FDA certification agent to get approved, and it has a letter stating that it offers a qualified environment. In other words, the qualification letter states that QAD software and procedures meet the strict FDA regulations. Each customer still has to get its internal procedures certified, but the company doesn’t have to worry about getting its systems and IT procedures documented and certified, which is a huge time and money saver. Life sciences customers also like the on-demand Read More...
Making SOP Training More Effective
Standard Operating Procedures (SOPs) are critical to efficient operations, quality control, and regulatory compliance. Yet many recent FDA violations have

fda guideline  compliance. Yet many recent FDA violations have focused on firms’ failure to properly use SOPs. This paper reviews best practices for the life science industry for training on SOPs. Specifically, how the latest learning management technology has the potential to improve learner retention through automated assessments. Read More...
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 guideline  of regulations such as FDA regulations 21 CFR 820 Quality System Regulation (QSR) and 21 CFR Part 11, along with ISO regulations ISO 9001 and ISO 13485:2003. Not only do today's solutions help manufacturers meet these mandates, they enable the highest levels of quality, productivity and profitability. Bringing the Best ERP Solution to the Medical Device Industry Today's ERP software can capture data, validate manufacturing processes, ensure product specifications are met, and provide rapid access to that Read More...
Enterprise Contract Management for Life Sciences: Integrating Contract Creation, Administration, and Execution
Leading life sciences companies are recognizing the need for synchronized, enterprise-wide pricing and contract management processes. An integrated solution can

fda guideline  Contract Management for Life Sciences: Integrating Contract Creation, Administration, and Execution Enterprise Contract Management for Life Sciences: Integrating Contract Creation, Administration, and Execution If you receive errors when attempting to view this white paper, please install the latest version of Adobe Reader. SAP Americas is a subsidiary of SAP AG, the world's largest business software company and the third-largest software supplier overall. SAP Americas' corporate headquarters Read More...
The ASP Decision
The ASP model is the latest in a long line of silver bullets that are supposed to simplify the delivery of technology’s benefits to the business world. This

fda guideline  ASP Decision Introduction About every eighteen to twenty-four months the technology industry identifies the latest in a long line of silver bullets that will simplify the delivery of technology's benefits to the business world. The ASP model has recently enjoyed that distinction and the accompanying hype. Unfortunately, wading through the hype to determine if this particular silver bullet can bring value to your business is an arduous task. This article provides some simple guidelines for determining Read More...
HighJump Grows in a Period of Low Growth Through Adaptable, Broad Function Products Part Four: Challenges and User Recommendations
The competition is becoming relentless given a slew of WMS vendors delivering sophisticated collaboration, visibility, and SCEM functionality. Further many of

fda guideline  regulatory compliances such as FDA 21 CFR Part 11 rule, that should be a springboard for other vertical initiatives, though) that other however rigid competitive products will have exhibited. The perception of its poor amenability to the upper-end of the market with highly complex requirements might additionally be aggravated by not a great number of deployments on upper-range OS and database platforms. Still, for the time being, HighJump seems content to bet on product's flexibility and uniformity at Read More...

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