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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. 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

21 cfr part 11 validation  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...
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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

21 cfr part 11 validation  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...
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

21 cfr part 11 validation  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...
Ross Systems' Focus Yields More Value For Process Manufacturers
For a vendor, focus is good, as it often results with more value to its targeted customers. A highly focused vendor can also remain profitable even in

21 cfr part 11 validation  5.7, will provide full 21 CFR Part 11 support for Electronic Records and Signatures, Audit Logs, etc. Life sciences customers using iRenaissance have achieved FDA validation and Ross will soon be offering more specific validation applications to help customers in their FDA validation efforts. Cambrex is a life sciences company with 100's of unique products and thousands of customers ranging from individual research scientists to large corporations. At Cambrex, responsive customer service requires highly Read More...
Compiere ERP Becomes Part of Consona
In the enterprise open source space, a notable change came to light today affecting Compiere users and partners. Consona announced its acquisition of Compiere.

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These Are the Times of CRM Vindication and Validation - Part 1
Some previous TEC blog posts have discussed the benefits (but also the inevitable caveats) of white papers, including the all-too-common vendors’ self

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QlikView 11 for BI Product Certification Report
QlikTech´s QlikView 11 has been TEC Certified for online evaluation of business intelligence (BI) solutions in the Business Intelligence and Data Management

21 cfr part 11 validation  QlikTech,QlikView 11,TEC certification,business intelligence solutions,BI Read More...
The Lexicon of CRM - Part 2: From J to Q
C.R.M. itself is an acronym, standing for Customer Relationship Management. This is part two of a three-part article to provide explanation and meaning for

21 cfr part 11 validation  crm ondemand,crm sales,crm white papers,web based crm,crm for small business,tracking sales,sales lead management software,on demand crm,automation sales,contact software,small business crm,olap software,sales management software,sales crm software,contact manager software Read More...
Lean Manufacturing: Part Two
Part One of the

21 cfr part 11 validation  lean manufacturing, lean principles, lean practices, inventory control, lean process ERP, kanban Read More...
Finding the Key to Small Manufacturer's Profits - Part 2
Part 1 of this blog series discussed the genesis of ProfitKey International, one of the longest-standing enterprise resource planning (ERP) providers for small

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UNIT4: The (Largely) Untold Story - Part 3
Part 1 of this blog post series started with my invitation by UNIT4 (formerly Unit 4 Agresso), the second largest business applications provider in continental

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Outsourcing 101 - A Primer Part Three: Approaches and Recommendations
Outsourcing is a very diverse market, and there are many different outsourcing options and outsourcing service providers to choose from. This part discusses

21 cfr part 11 validation  application development outsourcing,application outsourcing,article on outsourcing,benefits of outsourcing,bpo outsourcing,business outsourcing,business process outsource,business process outsourcing,business process outsourcing bpo,business processing outsourcing,company outsourcing,computer outsourcing,define outsourcing,global outsourcing,hr outsourcing vendors Read More...
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

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