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Complying with US FDA Title 21 CFR Part 11 for the Life Sciences Industry
Compliance with US FDA regulations is a market requirement. Thus, among the nearly 1,500 installations of mySAP ERP software among pharmaceutical, medical

fda 21 cfr  technical compliance with US FDA 21 CFR Part 11 Electronic Records; Electronic Signatures; Final Rule. Read More...
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The simplified definition of enterprise resource planning (ERP) software is a set of applications that automate finance and human resources departments and help manufacturers handle jobs such as or...
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Documents related to » fda 21 cfr


Five Must-have ERP Features for Medical Device Manufacturers
In the medical device manufacturing industry, errors can cost more than money—they can cost lives. In order to meet safety regulations, manufacturers are

fda 21 cfr  of regulations such as FDA regulations 21 CFR 820 Quality System Regulation (QSR) and 21 CFR Part 11, along with ISO regulations ISO 9001 and ISO 13485:2003. Not only do today's solutions help manufacturers meet these mandates, they enable the highest levels of quality, productivity and profitability. Bringing the Best ERP Solution to the Medical Device Industry Today's ERP software can capture data, validate manufacturing processes, ensure product specifications are met, and provide rapid access to that Read More...
Are You on Track for 21 CFR Part 203 Compliance?
It’s old, it’s new, and it’s the future. Pedigree tracking regulations were originally passed into law through the Prescription Drug Marketing Act of 1987 (PDMA

fda 21 cfr  Food and Drug Administration (FDA) has lifted its final stay. Pharmaceutical companies are expected to be in compliance with 21 CFR Part 203 by the year 2011. Do you have what it takes for compliance? Read More...
abas ERP Partners for Quality Management Software
abas-USA and Pickert & Partner GmbH recently announced a new partnership, which will integrate the Pickert RQM quality management system (QMS) with abas ERP

fda 21 cfr  VDA 6.1, VDA 6.4, FDA 21 CFR 11, EN 29001, 9342 EWG, ISO 13485, EN 9001 Aerospace Series, and AQAP 2110. Each of these elaborate standards has specific reporting requirements, data collection devices (e.g., machine readers, calibration devices, spectrometers, and chemical analysis readers), etc.   I am not sure whether any ERP vendor can maintain these standards and, more importantly, keep up with changing standards in a single package. In abas ERP one can look for quality data in inbound receipts, Read More...
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

fda 21 cfr  customer or conform to FDA requirements. According to FDA’s publication in 21 CFR 820.40, Medical Device Manufacturers are required to have written procedures for the approval and distribution of documents. The approval procedures must ensure that the documents meet the requirements of the QS/GMP as well as adequacy for their intended use. Obsolete documents must be removed from circulation, and document approvals must include a signature and date. Removal (or prevention of use) of obsolete documents mu Read More...
ERP Software Selection Case Study: DCI Cheese Company Manages Rapid Business Growth with Enterprise 21 ERP
To facilitate business expansion, DCI Cheese Company engaged in an enterprise resource planning (ERP) evaluation process to select a system capable of

fda 21 cfr  Software Selection Case Study: DCI Cheese Company Manages Rapid Business Growth with Enterprise 21 ERP To facilitate business expansion, DCI Cheese Company engaged in an enterprise resource planning (ERP) evaluation process to select a system capable of supporting its multiple companies, divisions, and business units—and to provide a single data source for real-time business information and transaction processing. Download this case study to find out why DCI selected TGI's Enterprise 21 ERP. Read More...
Case Study: Nu-West Construction Products
In 2005, Nu-West Construction Products was executing a rapid expansion plan that included three new distribution facilities in Western Canada. Believing it had

fda 21 cfr  Study: Nu-West Construction Products In 2005, Nu-West Construction Products was executing a rapid expansion plan that included three new distribution facilities in Western Canada. Believing it had outgrown its existing solutions, Nu-West conducted a comprehensive enterprise resource planning (ERP) software evaluation project to find a replacement. Learn how the chosen solution, TGI’s Enterprise 21 ERP, helped Nu-West meet its unique distribution needs. Read More...
ERP System21
The Infor ERP System21 Workspace recognizes that the employee is often the most important factor in business process performance. The workspace is designed

fda 21 cfr  system21 aurora web demo,system21 aurora screenshot,system21 aurora number clients spain,system21 aurora myob,system21 aurora installation steps,system21 aurora clients 2002 spain,java extension with system21,system21 supported database,system21 siebel integration,system21 erp,system21 aurora geac screenshot,compare system21 with sap,as400 system21 jobs,webstore services erp integration system21,vb 6 system21,erp system 21,erp supply chain management,erp system costs,erp vendors,erp benefits,erp system failure,erp modules,supply chain erp,erp management,erp portal,system21 (erp) user manual,system21 analyst,system21 as400,system21 as400 administration functions,system21 aurora schema,system21 hr system,system21 reports,system21 workspace,system21 reporting crystal open option Read More...
Symix Maintains Consistent Profitability Despite Y2K Market Conditions
On October 21, Symix Systems, Inc. announced financial results for the first quarter ended September 30, 1999. Total revenue increased 19 percent to $32.1

fda 21 cfr  infor software,syteline training,symix systems,infor syteline,erp products,syteline,infor visual,infor erp software,baan infor,erp product,syteline erp,erp lx,infor xa,s&op best practices,erp systems Read More...
Geac Decomposes To Survive
Geac, a struggling Canadian enterprise applications vendor has not found its white knight. It will, for the time being, have to sell parts of its business in

fda 21 cfr  Decomposes To Survive Geac Decomposes To Survive P.J. Jakovljevic - April 24, 2001 Event Summary On April 3, Geac Computer Corporation Limited (TSE: GAC), a struggling Canadian supplier of enterprise management software, announced that it has completed the sale of its hotel business to Galaxy Hotel Systems LLC for approximately $ 1 million (US). Galaxy Hotel Systems is a subsidiary of Starwood Hotels & Resorts Worldwide , Inc ., the largest client of the hotel business. The sale of the hotel business Read More...
IFS Far Cry From Running Out of Breath
In May, IFS reported results for Q1 2000. It generated revenue of $57.0 million, a 21% increase compared to a year ago. License revenue grew 73% quarter over

fda 21 cfr  great plains accounting software,hosted erp software,inventory control software for small business,inventory software package,inventory software packages,inventory software programs,inventory software solution,inventory software systems,online accounting software,online erp software,retail inventory software,small business account software,small business accounts software,small business crm,small business inventory control Read More...
Vendor Snapshot: Epicor at the TEC Vendor Challenge
At the upcoming 2013 TEC Vendor Challenge – ERP for Distribution event in Montreal, Epicor will be featuring its renowned distribution enterprise resource

fda 21 cfr  Snapshot: Epicor at the TEC Vendor Challenge At the upcoming  2013 TEC Vendor Challenge – ERP for Distribution  event in Montreal, Epicor will be featuring its renowned distribution enterprise resource planning (ERP) solution, Epicor Prophet 21 . In 2011, Apax Partners combined Activant Solutions Inc. (formerly Prophet 21 Inc. ) with Epicor Software Corporation to create one of the largest global providers of enterprise applications focused on the distribution, manufacturing, retail, and Read More...
Marketo Launches New Component of the Marketing Nation
The marketing automation provider Marketo introduces Marketo Program Exchange, a new addition to its Marketing Nation platform. Marketing Nation is a free-of

fda 21 cfr   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

fda 21 cfr  Food and Drug Administration’s (FDA’s) Title 21 Code of Federal Regulations (CFR) Part 11, for pharmaceutical manufacturers that are employing methods for electronic record-keeping and electronic and digital signatures. This increasing need often means that additional administrative time must be spent on ensuring that the technical and procedural protocols are set up correctly and doing what they are supposed to do. Another reason for long cycle times has to do with the need to ensure that all stages Read More...

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