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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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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.

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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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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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PeopleSoft's CEO Steps Down


On September 21, PeopleSoft founder David Duffield stepped down as chief executive of the struggling business software maker. The 12-year-old company announced that president and chief operations officer Craig Conway would take on the additional role of chief executive officer. Duffield will remain chairman of PeopleSoft's board.

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Epicor Enhances Its Major Wholesale Distribution ERP Product


Based on a recent slew of announcements by Epicor, both in terms of customer wins and product releases (across the original Epicor business as well as in the former Activant and Solarsoft businesses), I expect the upcoming Epicor Insights 2013 conference will be an interesting multiday event. Most recently, Epicor announced the general availability of version 12.11 of the Epicor Prophet 21

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Why Life Sciences Companies Should Engage on Social Media


While most industries are rapidly adopting social media to engage with customers, the life sciences companies remain typically balk at extending social presence in a highly regulated environment. In view of recent Food and Drug Administration (FDA) guidelines on the responsibilities of life sciences companies monitoring social media, this paper intends to assist life sciences companies in determining the scope and potential impact of creating a social media engagement program.

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BigMachines Launches BigMachines Express


BigMachines announces that BigMachines Express is now available on the Salesforce.com AppExchange. This solution targets small and medium-sized businesses that want to create product profiles, assign desired prices, and further generate proposals in Salesforce CRM. The solution is built on the Force.com platform, which allows for easy installation and configuration for Salesforce CRM users. The

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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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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.

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