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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 medical device compliance erp  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 pharmaceuticals and medical devices. The U.S. FDA (Food and Read More...
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Documents related to » fda medical device compliance 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

fda medical device compliance erp  sort criteria Adherence to FDA CFR 21 Part 11, including before and after transaction data values, and operation as a closed system . Additional functionality to support your compliance strategy SOPs can be supported in a variety of ways within Microsoft Great Plains. For organizations that manufacture medical devices, drawings can be attached to items so that everyone has easy access to technical specifications. Any organization that must adhere to SOPs will appreciate the ability to attach notes and 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 medical device compliance erp  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...
Do You Need a State-of-the-art ERP Solution?
As your company grows, you must continually evaluate whether your work processes and IT solutions can solve your problems and help grow your business. By

fda medical device compliance erp  other products subject to FDA recalls to be emergency ready to meet FDA mandates and avoid sanctions. Do your systems provide the following capabilities for meeting FDA demands? Does your system fully integrate all material planning processes and centrally capture traceability data? Does it support both forward traceability from ingredients to customer shipments and backward traceability from customer shipments to manufactured lots, and finally to ingredients or components received from suppliers? Does Read More...
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

fda medical device compliance erp  Food and Drug Administration (FDA)  certification or compliance. The majority of Epicor’s processes today are more along the lines of how to carry out, say, a quote-to-cash process, but the process library will grow. Over time, the vendor also hopes to tie these capabilities into the application for real-time business process modeling or at least generate  unified modeling language (UML )-based models to help drive the application. As of today, the produced process maps are outside of the Read More...
The ERP Ecosystem
Three major parties (vendors, consulting services, and adopting organizations) are identified in the ERP ecosystem, in which different parties need different

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To ERP or Not to ERP, that Is the C-level Question
Whether your organization is looking to take the leap into an enterprise resource planning (ERP) system for the first time or seeking to add to the current ERP

fda medical device compliance erp   Read More...
ERP in Manufacturing 2012: The Evolving ERP Strategy
This Aberdeen Group report, based on over 170 survey respondents in manufacturing, provides best-in-class manufacturing approaches to ERP strategy. Today, 92

fda medical device compliance erp  ERP,enterprise resource planning,manufacturing,2012,ERP strategies,ERP implementation,integrating ERP,tailor ERP Read More...
Enterprise 21
TGI@s Enterprise 21 ERP software offers a fully integrated software solution for wholesale distributors. Enterprise 21 ERP includes available-to-promise and

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Sage ERP X3
Sage ERP X3 provides medium-sized businesses with fully integrated functionality in all areas of business for accounting and financial management, purchasing

fda medical device compliance erp  ERP X3 Sage ERP X3 provides medium-sized businesses with fully integrated functionality in all areas of business for accounting and financial management, purchasing, inventory, sales, customer relationship management (CRM), and manufacturing. It offers both standard management features and in-depth process customization capabilities. The result is a range of configured offerings that covers the standard requirements of several industries, and is also adaptable to the needs of specific organizations: Read More...
Feds Warms Up to ERP Spending, but Will Contractors and Their ERP Vendors Comply? Part One: Event Summary and Market Impact
There has been noise in the US public sector about a strong federal (Feds) interest in ERP applications. This, coupled with the Feds customary huge purchasing

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The Path to ERP for Small Businesses, Part 3: Selection of ERP Software
The third and final part of the path to ERP for small businesses series describes the software selection stage, including the dos and don’ts during vendor

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2011 Trends Report: Enterprise Resource Planning (ERP)
Enterprise resource planning (ERP) automates many aspects of an organization’s operations, cascading across traditional boundaries of operations, finance

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iScala ERP Software
Epicor@s iScala enterprise resource planning (ERP) software enables businesses to automate and manage their standard business processes, and includes an e

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