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 21 cfr part 11 validation


Managing Compliance with 21 CFR Part 11
Compliance with regulatory requirements is a business-critical need you must maintain. But meeting this need is more challenging with the creation of new

21 cfr part 11 validation  Compliance with 21 CFR Part 11 Compliance with regulatory requirements is a business-critical need you must maintain. But meeting this need is more challenging with the creation of new regulations, such as 21 CFR Part 11, governing the use of software for secure data processing. But compliance is possible: an enterprise resource planning (ERP) system can help with audits, document and digital signatures, validation scripts, and other security needs.

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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 validation

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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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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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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Invensys Production Solutions - Can Historic Strengths And The 'Protean Boost' Overcome Its Liabilities? Part Two: Liabilities, Strategy, and User Recommendations


Invensys must communicate its successes and strategy to the marketplace, and must aggressively invest in customer satisfaction, marketing, and sales. IPS must convince customers and prospects that it is here to stay; while the functionally rich products are great advantages, many other considerations make some customers and prospects perceive these solutions a risk.

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Taking Stock of TAKE Supply Chain Solutions - Part 3


Part 1 of this blog series introduced TAKE Supply Chain, a supply chain management (SCM) division of TAKE Solutions, Ltd. The parent TAKE Solutions is a global technology solutions and service provider, which focuses on two principal business areas – life sciences and SCM (the company is listed on the Indian Stock Exchange). My first post described TAKE Supply Chain’s

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Info360 - the Information Management Event of the Year -- March 21-24 in Washington, DC


Learn how at the info360 Conference and Expo, March 21-24 in Washington, DC.

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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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Integration Validation of Networked Solutions


When implementing and running solution landscapes that drive mission-critical business processes, solution integration can be complex and challenging. Implementation work, typically distributed across many teams and many stakeholders, may include custom-built and third-party software. This paper discusses how you can make sure your solutions are integrated correctly so they run smoothly, without technical interruption.

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Global Trade Hits Home at MegaResistCap-Part III: Be Careful What You Ask For


In the first two parts of this series (part I, part II), Jim, director of IT at MegaResistCap, learned that the company’s recently rolled out enterprise resource planning (ERP) system would have to support global trade management (GTM) functionality more quickly than expected. He had sent an e-mail off to his chief information officer (CIO), Mike, suggesting a new project be set up and managed by

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UNIT4: The (Largely) Untold Story - Part 2


Part 1 of this series started with my invitation by UNIT4 (formerly Unit 4 Agresso), the second-largest business applications provider in continental Europe, to attend its UK 2010 user conference. Frankly, I was a bit skeptical about what new and exciting I might see and hear about at this event in light of the vendor’s analyst tour in Boston in late 2009. My post then

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