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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 : SYS 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


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...
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 an Read More...
The Challenges of Defining and Managing Governance, Risk Management, and Compliance
A broader, more structured approach is needed to effectively manage governance, risk management, and compliance (GRC). Enterprises will then be better able to

fda compliance policy guide erp  recommended. For instance, the FDA regulations for drug manufacturers are not fixed targets. Thus, compliance is a key objective for any regulated drug manufacturing company, but the requirements to meet compliance are subjective based upon product, production processes, and (perhaps most important) every company's tolerance for risk. Regulatory risk is the risk of being found out of compliance, and if a company accepts very limited risk, its cost of compliance will logically be high. Conversely, with mor 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 applica Read More...
SYSPRO ERP (version 6.1 SP1) for Mixed-mode Manufacturing ERP Certification Report
SYSPRO ERP (version 6.1 SP1) is TEC Certified for online evaluation of mixed-mode manufacturing enterprise resource planning (ERP) solutions in the ERP

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ERP Selection: Starting Out on the Right Foot
Enterprise resource planning (ERP) software selection and implementation can be complicated. But having an ERP strategy in place from the start makes it easier.

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Welcome to ERP Showdown: Infor ERP LN 6.1 vs. Epicor Vantage vs. Lawson M3 Discrete Manufacturing Solutions
I'm Larry Blitz, editor of TEC’s Vendor Showdown series. With enterprise resource planning (ERP) systems being the information backbone of the organization, we

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Sage ERP X3 (v. 6) for Process Manufacturing ERP Certification Report
Sage ERP X3 (v. 6) is TEC Certified for online evaluation of process manufacturing enterprise resource planning (ERP) solutions in the ERP Evaluation Center

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ERP in Manufacturing 2012: The Evolving ERP Strategy
This Aberdeen Group report, based on over 170 survey respondents in manufacturing, provides best-in-class manufacturing approaches to ERP strategy. Today, 92

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ERP: Justifying the Cost
Many benefits accrue from deploying an enterprise resource planning (ERP) system. Many of these are tangible or quantifiable in nature; you can calculate the

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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

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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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Get ERP Right the First Time: A Practical Guide to Selecting and Implementing a New ERP System
Every company faces different challenges and has different needs in regard to enterprise resource planning (ERP). Choosing the right ERP system can be difficult

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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