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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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Regulatory and Compliance RFI/RFP Template

Design for Compliance, Management of Hazardous and Controlled Substances, Regulatory and Compliance Documentation, Managing Recyclables and Controlled Waste, Product Technology Get this template

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Documents related to » 21 cfr part 11 compliant

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.

21 cfr part 11 compliant  architectural framework features, CFR 21 Part 11 (Code of Federal Regulations Title 21) regulatory compliance support (electronic records and signatures), and the ability to run iRenaissance over the web. Although iRenaissance has been run over the web by Ross' customers for more than two years now, it previously required a client-side plug-in like most of the other ERP systems require today. With the advent of Ross' new .NET-compliant architecture, however, iRenaissance is currently deployed with a Read More

Classic Enterprise Resource Planning Solution Shifts Over


About two-thirds of SoftBrands' revenue comes from its manufacturing division, which includes the Classic Fourth Shift solution and Fourth Shift Edition for SAP Business One, the result of a joint initiative to integrate Fourth Shift functionality with SAP Business One.

21 cfr part 11 compliant  Drug Administration (FDA) Title 21 Code of Federal Regulations Part 11 (21 CFR Part 11)-compliant PRIMR allows users to capture their paper-based data more easily and accurately in the highly demanding manufacturing environment. The data can then be used in a variety of ongoing quality compliance and operational tasks, such as process trending, specification setting, annual product reviews, and process validation. This alliance thus expands the value of the Fourth Shift Lot Trace Module . PRIMR's Read More

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

21 cfr part 11 compliant  address compliance issues, including 21 CFR Part 11. How does 21 CFR Part 11 relate to product R&D and approvals? For all of the processes involved in getting a drug to market, strict policies must be established and followed by a company regarding the use of electronic records. Each step of product R&D and approval processes must be, according to the dictates of 21 CFRR Part 11, consistent, reliable, and repeatable—in other words, each version of every document must be archived and easily retrieved Read More

The Name and Ownership Change Roulette Wheel for Marcam Stops at SSA Global Part Two: Marketing By Invensys


IPS was hoping that the early product vision and venerable reputation that Marcam has in the process manufacturing market for providing plant-centric ERP solutions might finally play well to capturing the marketing opportunity.

21 cfr part 11 compliant  in areas such as 21 CFR 11 Part 11, which was introduced to anticipate the effects of electronic technology' on the drug discovery, development, and manufacturing processes. Accordingly, FDA regulations focus on two areas: 1) electronic records (i.e., ensuring accuracy, reliability, consistency, and visibility to changes in records, with time stamped audit trails) and 2) electronic signatures (i.e., authorized on-line signature that is legally binding). To that end, both future releases of Protean at the Read More

Consona’s CEO Clearing the Air (about Compiere) - Part 2


Part 1 of this blog series talked about Consona Corporation’s recent acquisition of leading open source and cloud computing enterprise resource planning (ERP) provider Compiere. After reading a slew of speculative blog posts (including the one from TEC’s free and open source [FOSS] buff and advocate Josh Chalifour), I had an incisive briefing with Consona’s CEO Jeff Tognoni, to

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Curbing MESsy Shop Floor State of Affairs - Part III


Part II of this blog series expanded on some of TEC's earlier articles about companies' need for better links between the plant floor and the enterprise offices. It also pointed out the difficulties in achieving this noble idea, and gave examples of some vendors with success in providing integrated enterprise resource planning (ERP) and manufacturing execution system (MES) solutions. Another

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Up Close and Personal: Martin Schneider, Senior Director of Communications at SugarCRM-Part 2


In part one of my interview with Martin Schneider, Senior Director of Communications at SugarCRM, we discussed the history of SugarCRM and the open source customer relationship management (CRM) space. Part 2 describes SugarCRM’s approach to development, their partner ecosystem, and how social media has changed CRM.Q: About development—most of it is done by your team of programmers

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“Act Vertical” vs. “Go Extinct” Retailers - Part 3


Part 1 of this blog series set the historical background for supply chain management (SCM) evolution and presented the advantages and shortcomings of vertical vs. horizontal integration. The analysis then moved onto the generally embattled retail sector, where a select group of innovative retailers has found a “happy medium” approach to stay well above the fray. Kurt Salmon Associated (KSA

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To SaaS or Not, Is That a Question? - SaaSy Discussions (Part IIa)


The first part of this blog series described the opportunity for software as a service (SaaS) or on-demand enterprise applications, especially in the current difficult economic milieu. But before any vendor can embark on delivering a SaaS offering, it must understand several misconceptions about SaaS. Part two then analyzed the first two of the top five SaaS assumptions that Gartner recently

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Can We Intelligently Use Part Numbers to Configure and Order the Right Products?


In the industrial automation industry, an overlooked, fatal flaw of sales configurator solutions is their inability to simultaneously configure part numbers and products. A greater concern is their inability to "decipher" product specifications from part numbers—that is, in reverse.

21 cfr part 11 compliant  intelligent part numbers,meaningful part numbers,significant part numbers,product configurator,sales configurator,part numbers,industrial automation,IA,intelligent catalog numbers,reverse configuration variants,information technology,IT,bidirectional configuration,stock-keeping unit,SKU Read More

SAP HANA: A Fast Developing “Toddler” - Part 2


Part 1 of this blog series analyzed a snapshot of the SAP HANA offerings’ achievements at the time of the product’s first anniversary in June 2012. SAP is now a de facto database provider that intends to become the #2 database vendor by 2015. The company’s recently unveiled real-time data platform combines the SAP HANA platform, Sybase data management offerings, and SAP BusinessObjects solutions

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Compliant Manufacturing Operations in Life Sciences Companies: Compliant Operations to Lead the Competition


For many life sciences organizations, a key impediment to compliant manufacturing operations remains the disconnect between enterprise and plant systems. This results in unsynchronized business processes and inadequate use of resources, which in turn increases the risk of non-compliance and inadequate quality of finished products. Find out why simply connecting systems is not enough to fully overcome these challenges.

21 cfr part 11 compliant  manufacturing operations,manufacturing operations concern,manufacturing operations strategy,integrated and seamlessly operating mfg plant,research report on operations manufacturing,controls manufacturing system Read More

What's in a name? or Enterprise systems' reincarnations (Part II)


While the Part I of this topic focused on Consona Corporation (former M2M Holdings), this time the discussion continues with the recently minted Solarsoft entity, privately owned by Marlin Equity Partners. True, in Part I, besides Infor, I could have also mentioned as old news the renaming of Verticent ERP Plus (formerly PowerCerv [evaluate this product]) as part of the ASA International parent

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A Tale of a Few Good SCM Players - Part 3


Part 1 of this blog post series followed the progress of Manhattan Associates from its inception in 1990 throughout the mid-2000s. During this time, Manhattan was the epitome of a well-managed supply chain management (SCM) software company in terms of market share, growth, profitability, and its products’ capabilities. Indeed, the company set the industry standard for the

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