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 dmr fda guidelines


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

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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 » dmr fda guidelines

Are You Prepared for Validation?


For industries in regulated environments, validation of processes and systems is a required part of business. The goal of the validation process is to provide confidence in a process or system by demonstrating consistent and repeatable results through documented evidence. This article provides an overview of a validation for a computer software system, for compliance with US Food and Drug Administration (FDA) regulations.

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ProSight


ProSight offers investment management solutions for government and business. Founded in 1998 and headquartered in Portland, Oregon (US), ProSight applies the principles of portfolio management to business and technology investments. ProSight customers include the US Army, the US Food and Drug Administration (FDA), AT&T, DaimlerChrysler, and Hershey Foods.

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Usability as an ERP Selection Criteria


Enterprise resource planning (ERP) software is often criticized for being complex and difficult to use—which puts up a barrier to receiving potential benefits. Systems with integrated search functionality and Web-like interfaces can make ERP solutions easier to use. Learn how to evaluate ERP software for its usability, so you can avoid investing in platforms that aren’t evolved toward usable and efficient interfaces.

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Identifying Critical Change Control Failure Points


There are key systems in every infrastructure where unapproved change can pose significant business risk. These guidelines show you how to properly categorize these systems in order to identify those that have risk characteristics. By learning how to identify critical change control failure points in your infrastructure, you reduce the threat of costly downtime, potential security breaches, and compliance weaknesses.

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Automating Stimulus Fund Reporting


Tracking and reporting stimulus fund spending are difficult tasks for chief information officers (CIOs). The US government’s accountability demands are forcing organizations that are spending American Recovery and Reinvestment Act (ARRA) funds to analyze floods of data. Discover how automated ARRA reporting systems can help you comply with reporting requirements without excessive labor costs or data management headaches.

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Applying Lessons Learned in CRM Projects


The road to implementing customer relationship management (CRM) systems is fraught with risk and littered with failure. Paradoxically, reams have been written by industry practitioners explaining why CRM projects fail, yet the same patterns and mistakes are repeated—over and over again. While there is no magic bullet, following some simple guidelines can help assure CRM success for your organization.

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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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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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Making SOP Training More Effective


Standard Operating Procedures (SOPs) are critical to efficient operations, quality control, and regulatory compliance. Yet many recent FDA violations have focused on firms’ failure to properly use SOPs. This paper reviews best practices for the life science industry for training on SOPs. Specifically, how the latest learning management technology has the potential to improve learner retention through automated assessments.

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Process vs Discrete ERP


When researching the right manufacturing software for your business, it is important to realize there is a difference between process and discrete software. A discrete software solution for a process manufacturing company will inevitably fall short, but after you identify your manufacturing operation and requirements, what is the next step? Learn about what guidelines to follow when viewing manufacturing software to ensure your company needs are addressed.

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