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Software Functionality Revealed in Detail
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 21 cfr part 11 compliant


The Many Faces of PLM Part Two: The Future of the PLM Suite
The future of the PLM Suite will include more applications that cover product-related functionality and further expand the benefits available. As the PLM Suite

21 cfr part 11 compliant  capabilities to support FDA 21 CFR Part 11, an important requirement in the Life Sciences industry. This focus is increasingly important as new regulations are being unfurled, such as WEEE (Waste Electronic and Electrical Equipment) and the TREAD (Transportation Recall Enhancement, Accountability, and Documentation), whose requirements span large segments of the product lifecycle. PLM focus on regulatory and compliance issues is not entirely new, as SAP has long included Environmental Health and Safety

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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

Software Test Tools

Tools exist to support software testing at all stages of a project. Some vendors offer an integrated suite that will support testing and development throughout a project's life, from gathering requirements to supporting the live system. Some vendors concentrate on a single part of that life cycle. The software test tools knowledge base provides functional criteria you might expect from a testing tool, the infrastructure that supports the tool, and an idea of the market position of the vendor.  

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Documents related to » 21 cfr part 11 compliant

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 manufacturers can use to facilitate compliance requirements submissions. Get the details from P.J.'s post.

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HIPAA-Watch for Security Speeds Up Compliance Part One: Vendor and Product Information


HIPAA-Watch for Security is a tool designed to guide organizations through the risk analysis required by the Health Insurance Portability and Accountability Act (HIPAA) compliance process (US). Relevant Technologies, a leading security research and advisory firm, evaluated HIPAA-Watch for Security to verify how well it performed in guiding organizations through the HIPAA security risk analysis process.

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Managing the Aches and Pains of Long Cycle Times: Automating Controls for Pharmaceutical Manufacturers


One of the biggest challenges (or business pain points) for pharmaceutical manufacturers (or life sciences companies) is the long cycles that are required for research and development (R@D) and product approval. This is particularly a challenge for manufacturers of generic drugs, for which cycle times can average 20 months or more (and the full time-to-market period upwards of 12 years). Why

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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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Mega-vendors Warming Up to the Cloud - Part 2


Part 1 of this blog series depicted the three evolutionary phases (or waves) of software as a service (SaaS) and cloud computing adoption. The article ended with some glimpses into the future and likely implications for SaaS users. Part 2 explores the apparent opportunities and accompanying challenges (and inevitable soul-searching exercises) that SaaS aspirants face in their endeavors. Some

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The Wizardry of Business Process Management - Part 4


Part 1 of this blog series started a lengthy discussion about the value proposition and parts-and-parcels of business process management (BPM), with an ensuing focus on Pegasystems (also known as Pega) as one of the leading BPM suite providers. Part 2 then analyzed in depth the vendor’s ability to help business users capture (and then realize) business objectives and intent, while Part 3 focused

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Frankie Does ERP, Part 1


[Editor’s note: Frank is not a composite character. He is a real person, employed at a real company. I’ve changed certain identifying particulars at his request. This interactive series, created and published with his permission, is an exercise in what-if analysis based on interviews I am currently conducting with him. You may find Frank’s use of language a little colorful. I have toned

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They do it like that in the Balkans-Select and deploy ERP, I mean (Part II)


The Part I of this blog topic concluded with SAP's supremacy in the upper-end of the regional market. What also helps SAP ERP [evaluate this product] is a number of well-established value added resellers (VARs) that cover the entire former Yugoslavia region, some of which have a few dozen renowned installation sites (customer references) and a roster of experienced consultants. Some of these are

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Nothing Succeeds Like Success(Factors) - Part 2


Part 1 of this series introduced SuccessFactors, a public provider of software as a service (SaaS) talent management solutions. My post first analyzed the vendor’s evolution from its traditional People Performance realm to the seemingly more opportune Business Execution (BizX) province. Then, I talked about SuccessFactors’ multiple product editions to satisfy companies of

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The Power of Knowledge -- Knowledge is Power (Part 3)


Part 1 of this blog series introduced the need for knowledge management (KM) software applications as part of a more comprehensive and strategic service management (SSM) suite. One such broad SSM suite has been advanced by Servigistics, and Part 2 zoomed into the capabilities of one particular part of the Servigistics SSM suite: Service Knowledge Management (SKM). Potential SKM Benefits

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