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Software Functionality Revealed in Detail
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 fda 21 cfr


Complying with US FDA Title 21 CFR Part 11 for the Life Sciences Industry
Compliance with US FDA regulations is a market requirement. Thus, among the nearly 1,500 installations of mySAP ERP software among pharmaceutical, medical

fda 21 cfr  technical compliance with US FDA 21 CFR Part 11 Electronic Records; Electronic Signatures; Final Rule.

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Software Functionality Revealed in Detail

We’ve opened the hood on every major category of enterprise software. Learn about thousands of features and functions, and how enterprise software really works.

Get free sample report
Compare Software Solutions

Visit the TEC store to compare leading software by functionality, so that you can make accurate and informed software purchasing decisions.

Compare Now

Documents related to » fda 21 cfr

Are You on Track for 21 CFR Part 203 Compliance?


It’s old, it’s new, and it’s the future. Pedigree tracking regulations were originally passed into law through the Prescription Drug Marketing Act of 1987 (PDMA). After two decades of postponing enforcement, the US Food and Drug Administration (FDA) has lifted its final stay. Pharmaceutical companies are expected to be in compliance with 21 CFR Part 203 by the year 2011. Do you have what it takes for compliance?

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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 have long embraced enterprise resource planning (ERP) and customer relationship management (CRM), but primarily use them to achieve operational efficiencies. However these systems can play a significant role in their abilities to comply with strictly FDA regulations.

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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 turning to enterprise resource planning (ERP) solutions. Discover the five features any medical device manufacturer should look for in an ERP system in order to meet compliance requirements, produce high-quality products, operate efficiently, and maximize profitability.

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abas ERP Partners for Quality Management Software


abas-USA and Pickert & Partner GmbH recently announced a new partnership, which will integrate the Pickert RQM quality management system (QMS) with abas ERP. The integration of these enterprise systems aims to support quality standards through most production-related processes across the entire value chain from the enterprise resource planning (ERP) system to machine controls.

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JBA: Will it remain "@ctive Enterprise"?


In 1999, JBA launched its @ctive Enterprise Series product line, which allows customers to dynamically model and continuously update their business processes. While the merger with GEAC brings some positive prospects, JBA's ambitious R&D pipeline may be jeopardized.

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Food Safety, Government Regulations, and Brand Protection


Many food companies are investing significant funds in building awareness for their brands in the market, which can pay off amply in competitive, commodity markets. One highly publicized recall, however, can turn an established brand asset into a liability.

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The 7 Deadly Sins of Software Selection


Q: How many doomsday prophets does it take to change a light bulb? A: None. The light is still on. “Knock knock.” “Who’s there?” “The Raptured. SURPRISE!” Thank you, thank you, don’t forget to tip the archangels, I’ll be here all week (according to best estimates). You may have heard recently about Harold Camping, the radio host who predicted that The Rapture would take

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RFID in Healthcare--A Whole Industry of Value


This article talks about recent and expected FDA regulations and how RFID can help meet those requirements while improving supply chain performance.

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Market Insight: Strategies for Overcoming Compliance Issues in the Pharmaceutical Industry


To successfully meet compliance demands, pharmaceutical manufacturers must develop, implement, and track the effectiveness of a company-wide compliance strategy. Key to that strategy is to adopt industry-specific enterprise software with functionality that supports Federal Drug Administration (FDA) requirements. Learn more about the criteria and recommendations you need to achieve compliance in the pharmaceutical industry.

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Resurrection, Vitality And Perseverance Of Former ERP 'Goners' Part One: Ross Systems & SSA Global Technologies


While an increasing demand for services and incremental purchases of new extended-ERP functionality from existing client base, with a modest ooze of new accounts and even a notable influx of new accounts for distinguished some, may not put the revitalized former ERP losers back on top of the enterprise applications charts, they will likely remain around and not necessarily just to impede mid-market forays of both Tier 1 brethren and the likes of Microsoft.

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