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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 compliance policy guide erp  ERP/CRM Software to Facilitate FDA Compliance Medical Device Manufacturers Can Leverage ERP/CRM Software to Facilitate FDA Compliance If you receive errors when attempting to view this white paper, please install the latest version of Adobe Reader. With more than 30 years' history and as one of the first software vendors to develop an enterprise resource planning (ERP) solution, SYSPRO is the longest standing and largest independent, international vendor of enterprise business solutions. Source : Read More

Regulatory and Compliance
Regulatory compliance covers the requirements for ensuring products and their associated materials comply with both external and internal rules and regulations. It covers regulatory and requirement...
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Documents related to » fda compliance policy guide erp


ERP Systems Buyer’s Guide
The implementation of an enterprise resource planning (ERP) system to automate business processes is a strategic investment. Buying the right system and

fda compliance policy guide erp  Food and Drug Administration (FDA ) guidelines and current Good Manufacturing Practice (cGMP) standards. In general, the point of comparison between industry-specific ERP and core ERP modules is that the former needs to be configured as per the industry processes and regulations, while this is not the case with core ERP modules. Almost every vendor tends to include industry-specific functionalities in its ERP offering, enabling product differentiation. A detailed list of industry-specific ERP solutions Read More
Automotive Industry and Food, Safety, and Drug Regulations
Enterprise application providers wanting to address the distinct regulatory requirements of the automotive, food, safety, and life sciences industries need to

fda compliance policy guide erp  Drugs, which is an FDA Compliance Policy Guide that describes how the FDA intends to enforce regulations related to labeling, electronic records, and product quality for pharmaceutical manufacturers, re-packers, re-labelers, distributors, and retailers; and US state regulations, since several states are establishing mandates that require pharmaceutical wholesalers and distributors to maintain pedigrees for every drug shipped (see Drug Pedigree Guidelines and How Software Can Help ). The enterprise Read More
TEC's Mid-market ERP-Distribution Buyer’s Guide
Midsize manufacturers and distributors now have access to an array of powerful software solutions that simply weren’t available before. But with so many choices

fda compliance policy guide erp  intense scrutiny by the FDA, the company faced new demands stemming from the Bioterrorism Act and the Customs Trade-Partnership Against Terrorism (CT-PAT) program as well as the enactment of the Sarbanes-Oxley Act. Many of the compliance activities were handled by manual processes with various spreadsheets, leading to insufficient controls with limited real time reporting. The company recognized the need to implement a new back office system, but the increasing demands placed on publicly-traded companies Read More
One Vendor's Dedicated Governance, Risk Management, and Compliance Unit
SAP's governance, risk management, and compliance roadmap is still in its beginning stages. Only time will prove the vendor's delivery of true, tangible

fda compliance policy guide erp  Food and Drug Administration (FDA) compliance tools, with Oracle, Microsoft , Lawson , Infor , LogicalApps , Oversight Systems , and CODA being only some of the more notable ones. Still, SAP's concerted effort deserves kudos, since even now the vendor offers a GRC solution set that covers a range of regulations in such areas as anti-terrorism, anti-money laundering, Basel II, Solvency II, data privacy, SOX compliance, and beyond, as opposed to most competitors' sporadic GRC nuggets. Most notably, SAP has Read More
Midmarket ERP Solutions Buyer’s Guide
For all but the smallest organizations, an enterprise resource planning (ERP) system promises big gains, helping to grow revenue, increase productivity company

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Feds Warms Up to ERP Spending, but Will Contractors and Their ERP Vendors Comply? Part One: Event Summary and Market Impact
There has been noise in the US public sector about a strong federal (Feds) interest in ERP applications. This, coupled with the Feds customary huge purchasing

fda compliance policy guide erp  Warms Up to ERP Spending, but Will Contractors and Their ERP Vendors Comply? Part One: Event Summary and Market Impact Event Summary It appears that the federal market's hunger for enterprise resource planning (ERP) systems will not subside any time soon. Namely, driven by system consolidation at the Department of Homeland Security and Administration management mandates, the federal market for ERP products and services will hit $7.7 billion (USD) in fiscal 2009, a 37 percent increase over fiscal 2004 Read More
Ross ERP (V 7.0.3) Is TEC Certified for Process Manufacturing ERP
TEC is pleased to announce that Ross ERP (V 7.0.3) by Aptean is now TEC Certified for process manufacturing enterprise resource planning (ERP). Ross ERP aims to

fda compliance policy guide erp  Ross ERP, TEC certification, Aptean, process manufacturing, process ERP, Aptean ERP, recipe-based, track and trace, Read More
Sage ERP X3 (v. 6) for Discrete Manufacturing ERP Certification Report
Sage ERP X3 (v. 6) is TEC Certified for online evaluation of discrete manufacturing enterprise resource planning (ERP) solutions in the ERP Evaluation Center

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Sage 500 ERP
Sage 500 ERP (formerly Sage ERP MAS 500) is an integrated series of applications covering most areas of business for enterprises with 20 to 1,000 employees

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Sage 100 Standard ERP (v. 4.5) for Discrete Manufacturing ERP Certification Report
Sage 100 Standard ERP (formerly Sage ERP MAS 90), v. 4.5, is TEC Certified for online evaluation of discrete manufacturing enterprise resource planning (ERP

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Ramco Enterprise Process Manufacturing for ERP for Process Manufacturing Certification Report
Ramco Enterprise Process Manufacturing is TEC Certified for online evaluation enterprise resource planning (ERP) for process manufacturing solutions in the ERP

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Sage 300 ERP 6.0 Certification Report (ERP for Distribution)
Sage 300 ERP (formerly Sage ERP Accpac) 6.0 is TEC Certified for online evaluation of enterprise resource planning (ERP) solutions for distribution in the ERP

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NetSuite ERP TEC Certified in Discrete Manufacturing ERP
TEC is pleased to announce that NetSuite ERP is now TEC Certified for discrete manufacturing enterprise resource planning (ERP) under TEC’s ERP Evaluation

fda compliance policy guide erp   Read More
Epicor ERP Software System (v. 9.05) for ETO Manufacturers ERP Certification Report
Epicor ERP Software System (v. 9.05) is now TEC Certified for online evaluation of enterprise resource planning (ERP) solutions for engineer-to-order (ETO

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