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Product Lifecycle Management (PLM)
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...
 

 fda medical device compliance plm


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

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Product Lifecycle Management (PLM) Comprehensive RFI/RFP Template

ore PLM for both discrete and process industries (Engineering Change Management, Data Vaulting, BOM Management, Recipe Management, Product Cost Estimation, etc.), Product Development and Portfolio ... Get this template

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Product Lifecycle Management (PLM)
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...

Documents related to » fda medical device compliance plm

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 offer enterprises industry-oriented enterprise resource planning systems that are sound and compliance-ready.

fda medical device compliance plm  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 applications, while competitors are still on their first, or second at best. Nevertheless, IFS has a tough road ahead.

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

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 processes that set you apart from other manufacturing companies. And, your regulatory requirements, including 21 CFR part 11, aren’t like those of any other industry. The challenge is to manage compliance risks and compliance costs. Learn about an ERP compliance strategy.

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

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 PTC CEO Jim Heppelmann’s seven trends, which formed the backbone of his keynote presentation at the PTC Live Global 2013 event held in California in June. PTC Live Global also had a companion Service Exchange (formerly Servigistics Exchange

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

Enhancing Governance, Risk, and Compliance through Effective Risk Management


Embedding governance, risk, and compliance (GRC) management into all business process has become imperative. Companies need to adopt a holistic view when it comes to reducing and managing risks, and ensure better access risk management. This paper discusses the need for companies to take a proactive approach towards access risk management.

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Is MAPICS Getting the Magic of PLM? Part Three: Challenges and User Recommendations


MAPICS hereby joins the raft of enterprise resource planning (ERP) vendors that are making their way into the product lifecycle management (PLM) market by bundling or partnering strategically to embed PLM functions within their suites.

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LogRhythm and SOX Compliance


In order for a business to stay on top of compliance requirements required by the Sarbanes-Oxley Act (SOX)—and avoid financial penalties or possible jail time—it must take a good look at its IT environment and financial reporting processes. The collection, management, and analysis of log data are integral to meeting SOX requirements and as such, require a system that automates these processes across the IT infrastructure.

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Lectra Fashion PLM: PLM for the Fashion Industry Competitor Analysis Report


Product Lifecycle Management (PLM) for Fashion is an evaluation model containing tailored PLM criteria and extra functionalities that serve the specificities of this industry in order to help fashion goods (including apparel, footwear, accessory and home fashion) manufacturers and retailers to achieve more efficient product development, lower cost, and better collaboration and control throughout the whole supply chain.

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Implementing Medical Manufacturing Technology to Improve Operations and Control Costs


US manufacturers spend over $25 billion every year on product warranty claims. For medical equipment manufacturers, complex government regulations play a large part in the rising costs of warranty. Learn how manufacturing technology can help improve product quality and minimize the burden of warranty costs by creating records that can be tapped by lawyers, or by the companies themselves, when faced with warranty issues.

fda medical device compliance plm  Medical Manufacturing Technology to Improve Operations and Control Costs US manufacturers spend over $25 billion every year on product warranty claims. For medical equipment manufacturers, complex government regulations play a large part in the rising costs of warranty. Learn how manufacturing technology can help improve product quality and minimize the burden of warranty costs by creating records that can be tapped by lawyers, or by the companies themselves, when faced with warranty issues. Read More

How a Leading Vendor Embraces Governance, Risk Management, and Compliance


SAP AG has long committed to placing compliance at the core of its product suite, as the vendor has recognized the growing role of enterprise systems in assisting companies to meet the increasing challenges of corporate compliance and risk management.

fda medical device compliance plm  Food and Drug Administration (FDA) requirements for pharmaceutical companies; and Basel II for the banking sector. This is part one of the two-part article How a Leading Vendor Embraces Governance, Risk Management, and Compliance . In part two, SAP's GRC product suite will be discussed in more detail, and speculation will be made on the product suite's potential for success within the vendor's current and prospective customer base. Read More

Privileged User Monitoring for SOX Compliance


Many companies face the Sarbanes-Oxley (SOX) compliance challenge of monitoring all the data activity of their most privileged users. Those challenges include tracking access to sensitive financial data, reporting on controls, and responding to problems. Learn about a database auditing and protection solution that can help capture targeted activities, without impacting the performance of production databases and software.

fda medical device compliance plm   Read More

IBM OpenPages Policy and Compliance Management


This video introduces the IBM OpenPages GRC Platform and, specifically, the Policy and Compliance Management module.

fda medical device compliance plm  risk management, enterprise risk management, risk management, governance, risk, and compliance, GRC requirements, GRC, corporate GRC, enterprise GRC, IBM OpenPages GRC Platform, enterprise GRC software, risk management solutions Read More

Omnify Empower PLM


The Omnify product lifecycle management (PLM) system provides a single location for all members of design and manufacturing teams to share information for designing, manufacturing, and supporting products. Omnify Empower allows visibility into the entire product development process by managing the complete product record including component data, bills of materials (BOMs), engineering changes, documentation, projects, quality assurance and corrective and preventative action (CAPA), and training requirements information. The system is designed to manage product content information such as BOMs, component attributes, design drawings, datasheets, and vendor (manufacturer and supplier) information. It automates requesting, tracking, and executing changes on product information. Omnify leverages an organization’s current environment for implementation without interruption to existing processes. The Omnify PLM solution is built on the Microsoft.NET Framework and supplies out-of-the-box, bi-directional interfaces with computer-aided design (CAD) and computer-aided engineering (CAE) tools, and enterprise application systems, such as enterprise resource planning (ERP), materials resource planning (MRP), and customer relationship managment (CRM).  

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