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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 medical device compliance plm  | Manufacturing Process for FDA Regulated Medical Devices | ERP for Medical and Surgical Device Industry | Manufacturer of Medical Appliance | Medical Devices Manufacturing White Papers | ERP Software for Medical Appliance Manufacturers | 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 Read More
Product Lifecycle Management (PLM)
This comprehensive product lifecycle management (PLM) knowledge base models modern product and design-related aspects of PLM for both discrete and process industries. It details product development...
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Documents related to » fda medical device compliance plm


PTC Submits Test Data to FDA’s Global UDI Database
Working with the FDA and major medical device manufacturers, PTC has developed a Global Unique Device Identifier Database (GUDID) submission solution that such

fda medical device compliance plm  PTC worked with the FDA and major medical device manufacturers to develop a GUDID submission solution. Built on the PTC Windchill product lifecycle management (PLM) platform, the PTC UDI solution is a preconfigured software solution, validated in accordance with 21 CFR Part 11 requirements, designed to help medical device manufacturers meet the needs of UDI submissions as quickly and effectively as possible. Any PLM software vendor that targets the medical devices industry will have to follow PTC’s Read More
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 plm  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
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 medical device compliance plm  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
PTC Live Global 2013: All About Design for “Servitization” —Part Two
Last week on the TEC blog I talked about market shifts and technological changes that are reshaping the competitive landscape for manufacturing firms, based on

fda medical device compliance plm  benefit from the upcoming FDA Unique Device Identification (UDI) compliance, while hi-tech companies should be interested in the product analytics capabilities, including conflict minerals reporting capabilities for the looming 2014 regulatory requirements. Automatic project execution capabilities as well as global quality and enterprise component and supplier management are some other upcoming enhancements slated for Windchill 10.2 later this year. PTC Creo Traction The current PTC Creo 2.0 release has Read More
Agile PLM
Oracle's Agile Product Lifecycle Management (PLM) Solutions can help companies manage information, processes, and decisions about their products throughout

fda medical device compliance plm   Read More
Core PLM for Process Industries
The foundation of product lifecycle management (PLM) for the process (or recipe-based) manufacturing industries is product data management (PDM). It covers

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PTC Windchill 10 for Core PLM for Discrete Industries Certification Report
PTC Windchill 10 is TEC Certified for online evaluation of core product lifecycle management (PLM) for discrete industries solutions in the Core PLM for

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Profiting from PCI Compliance
Although the Payment Card Industry Data Security Standard (PCI DSS) has become a global requirement, many organizations are lagging in compliance. For many

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4 Steps to Choosing the Right Device for Field Service Mobility
Choosing the right device for field service management needs is not easy. This white paper will guide you through the different factors, including your

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PLM (Vendors) and Lean Product Development-Part 3: Siemens PLM Software
After talking about Dassault Systèmes in Part 2 of this blog series, I’d like to move to another prominent player in the product lifecycle management (PLM

fda medical device compliance plm   Read More
Out-of-the-box PLM: PLM and E-collaboration Software for the Electronics Industry
Electronics manufacturing is one of the most complex manufacturing processes. Special software functionality is required to manage information throughout the

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TEC Guides Carolina Pad Through a Smooth PLM Software Evaluation and Selection Project
When school and office product business Carolina Pad needed help selecting the right product lifecycle management (PLM) software solution to replace its

fda medical device compliance plm  TEC case study, Carolina Pad, PLM case study, PLM selection, product lifecycle management, PLM, PLM selection, PLM software selection, TEC PLM Read More
Compliance: A Work in Progress
There’s no magic bullet for compliance success@even the most experienced organizations use a combination of reliable processes and proven technologies to get

fda medical device compliance plm   Read More

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