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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

erp fda regulatory assistance  Compliance Certificates Medical | ERP FDA Approval | ERP FDA Approval Guidelines | ERP FDA Compliance | ERP FDA Compliance Consultants | ERP FDA Compliance Consulting | ERP FDA Compliance Guidance | ERP FDA Compliance Guide | ERP FDA Compliance Guidelines | ERP FDA Compliance Manual | ERP FDA Compliance Officer | ERP FDA Compliance Policy | ERP FDA Compliance Policy Guide | ERP FDA Compliance Program | ERP FDA Compliance Programs | ERP FDA Compliance Software | ERP FDA Compliance Testing | ERP FDA Read More...
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 requirement...
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Documents related to » erp fda regulatory assistance


Invensys Production Solutions - Can Historic Strengths And The 'Protean Boost' Overcome Its Liabilities? Part Two: Liabilities, Strategy, and User Recommendations
Invensys must communicate its successes and strategy to the marketplace, and must aggressively invest in customer satisfaction, marketing, and sales. IPS must

erp fda regulatory assistance  requirements, enterprises with legacy ERP instances are demanding that their vendors extend their depth in areas such as 21 CFR 11 Part 11, which was introduce to anticipate the effects of electronic technology' on the drug discovery, development, and manufacturing processes. To that end FDA regulations focus on two areas: 1) electronic records (i.e., ensuring accuracy, reliability, consistency, and visibility to changes in records, with time stamped audit trails) and 2) electronic signatures (i.e., Read More...
How Much Wisdom Will BRAIN Bring To Agilisys? Part 2: Challenges and User Recommendations
As long as both Agilisys and BRAIN remain focused on their industries and do not become too distracted with each other’s verticals, everyone should do well.

erp fda regulatory assistance  German provider of specialized ERP and Supply Chain Execution (SCE) software primarily to automotive suppliers and other selected industries worldwide. Jim Schaper, Agilisys Chairman and CEO, has appointed Ernst Gemmasmer to the post of Senior Vice President (SVP) to lead the European operations of BRAIN Automotive. Post-transaction, the BRAIN Automotive and the BRAIN Industries subsidiaries will reportedly operate as separate business units of Agilisys International. The acquisition was financed through Read More...
SAP Industry Solutions for Mid-market Companies
For over a decade, SAP has offered industry-specific applications, starting with oil and gas and utilities solutions. Media, insurance, chemicals, banking, and

erp fda regulatory assistance  enterprise suites like mySAP ERP and mySAP CRM , as well as applications for user productivity and analytics, have all recently been designed with an industry perspective. Certainly, insights from SAP's core or standard developments, along with partner solutions, benefit all of SAP's industry units, and cover common business processes. But each industry has particular demands that cannot be met by generic solutions, and SAP thus invests in complementary programs, with the goal of a complete and Read More...
ERP Upgrades: What's Your Philosophy? 2012 OAUG Survey on Enterprise Application/ERP Suite Upgrade Strategies
Moving to the latest release of an enterprise resource planning (ERP) system is often perceived as a daunting task. But a new survey of enterprise system

erp fda regulatory assistance  managers finds that most ERP upgrade efforts tend to be short in duration, fall within reasonable budgets, and rarely disrupt the business at large. Download this report for detailed survey results tracking enterprise application suite upgrade activity at respondents' businesses. Read More...
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

erp fda regulatory assistance  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. Read More...
Software-as-a-service ERP versus On-premise ERP through the Lens of Total Cost of Ownership
This IDC white paper looks at the growing applicability of software as a service (SaaS) for enterprise-level business applications, and analyzes the adoption

erp fda regulatory assistance  as-a-service ERP versus On-premise ERP through the Lens of Total Cost of Ownership This IDC white paper looks at the growing applicability of software as a service (SaaS) for enterprise-level business applications, and analyzes the adoption rate and total cost of ownership (TCO) of this technological approach. Download this white paper to find out how a hosted option can drive significant cost savings, reduce initial implementation times, and bring new functionality with relative ease and Read More...
Future Tech: Where Will ERP Be in Two Years?
Many ERP systems are deeply entrenched in organizations, and their core technologies are mature. And yet ERP is in a state of flux. The ERP system of the future

erp fda regulatory assistance  Tech: Where Will ERP Be in Two Years? Many ERP systems are deeply entrenched in organizations, and their core technologies are mature. And yet ERP is in a state of flux. The ERP system of the future promises to be simpler, more accessible, and easier to use, shaped by trends that only recently began taking hold. Download this concise executive brief to get an expert's take on what's next for ERP, in clear, easy-to-read language. Read More...
Optimizing Returns from ERP Implementation
Enterprise resource planning (ERP) systems can help manufacturers solve business problems and increase return on investment (ROI), but their implementation

erp fda regulatory assistance  Returns from ERP Implementation Enterprise resource planning (ERP) systems can help manufacturers solve business problems and increase return on investment (ROI), but their implementation should not be taken lightly. In this interview, experts from SAP, Infor, and Microsoft discuss factors affecting ROI from an ERP system. The panel offer viewpoints on the feasibility of measuring ROI, importance of ownership of ERP implementation, anticipated and real benefits, and benchmarks and drivers Read More...
Sage ERP X3: Discrete Manufacturing (ERP) Competitor Analysis Report
The discrete enterprise resource planning (ERP) knowledge base addresses discrete manufacturing (distinct items such as auto parts or chairs) as well as non

erp fda regulatory assistance  ERP X3: Discrete Manufacturing (ERP) Competitor Analysis Report The discrete enterprise resource planning (ERP) knowledge base addresses discrete manufacturing (distinct items such as auto parts or chairs) as well as non-manufacturing industries. Research vendors that support a range of functionality for production planning, shop floor control, and product costing. The knowledge base also provides information on financials, human resources, and other enterprise management modules. 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

erp fda regulatory assistance  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...
Process Manufacturing (ERP)
The simplified definition of enterprise resource planning (ERP) software is a set of applications that automate finance and human resources departments and

erp fda regulatory assistance  processing and production scheduling. ERP began as a term used to describe a sophisticated and integrated software system used for manufacturing. In its simplest sense, ERP systems create interactive environments designed to help companies manage and analyze the business processes associated with manufacturing goods, such as inventory control, order taking, accounting, and much more. Although this basic definition still holds true for ERP systems, today its definition is expanding. Today's leading ERP sys Read More...
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

erp fda regulatory assistance  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, Read More...
Beyond Traditional ERP: ERP Features and Functions for Engineer-to-order Manufacturers
Due to the complexity of engineer-to-order (ETO manufacturing, companies must move beyond the features typically offered by a traditional enterprise resource

erp fda regulatory assistance  Traditional ERP: ERP Features and Functions for Engineer-to-order Manufacturers Due to the complexity of engineer-to-order (ETO manufacturing, companies must move beyond the features typically offered by a traditional enterprise resource planning (ERP) implementation. Learn about the specific ERP features and functions that help ETO manufacturers reduce costs, shorten cycle times, and improve ordering while maintaining high quality, and discover the key steps to enhance an ETO ERP implementation. Read More...
NetSuite ERP TEC Certified in Discrete Manufacturing ERP
TEC is pleased to announce that NetSuite ERP is now TEC Certified for discrete manufacturing enterprise resource planning (ERP) under TEC’s ERP Evaluation

erp fda regulatory assistance  ERP TEC Certified in Discrete Manufacturing ERP TEC is pleased to announce that NetSuite ERP is now TEC Certified for discrete manufacturing enterprise resource planning (ERP) under TEC’s ERP Evaluation Center. To obtain TEC certification, NetSuite completed TEC’s detailed research questionnaire and went through a formal, live demonstration of NetSuite ERP with TEC analysts. NetSuite was founded in 1998 by Larry Ellison and Evan Goldberg and is publicly traded on the New York Stock Exchange Read More...

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