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 fda compliance solutions erp


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 solutions 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 :

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Browse RFP templates

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Visit the TEC store to compare leading software by functionality, so that you can make accurate and informed software purchasing decisions.

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Regulatory and Compliance Software Evaluation Report

The Regulatory and Compliance Knowledge Base covers the requirements for ensuring products and their associated materials comply with both external and intenal rules and regulations. It covers regulatory and requirements needs, as well as product related components of Environmental Health and Safety (EH&S). 

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Documents related to » fda compliance solutions erp

Mid-Market Strategy: International Enterprise Solutions


Adonix marks its strategy with two catchwords: "growth" and "independence". It has carefully assessed and added acquisitions to broaden Adonix X3 suite's functional scope, licenses and services; and continues nurture internal development with its own resources.

fda compliance solutions erp  Food and Drug Agency-registered (FDA) manufacturers comply with regulatory requirements imposed by legislation such as the Bioterrorism Act and 21 CFR Part 11. It is ideally suited for companies producing coatings, adhesives, and sealants, as well as other batch-produced products. Since Adonix X3 also has solid discrete manufacturing capabilities to complement its process manufacturing orientation, it may also allow some mixed-mode manufacturing environments to freely adapt their systems to the style of Read More

Global Trade and the Role of Governance, Risk Management, and Compliance Software


The growing number of legal and regulatory requirements associated with global trading is one of many reasons enterprises are looking into global trade management applications, and into harnessing the up-and-coming, strategic software category of governance, risk management, and compliance.

fda compliance solutions erp  incarceration of executives (see FDA Compliance For The Life Sciences ). As another example, implementing and ensuring compliance with employee safety guidelines, monitoring emissions (which are often delineated by regulatory permits), and even validating the origin and composition of chemical products are all mission-critical processes that contribute to the cost of doing business. In other words, as explained in So, What's the Big Deal with Chemicals? , a new complexity that comes from some process Read More

Orchid Orthopedic Solutions Selects CEBOS QMS


Orchid Orthopedic Solutions recently selected CEBOS MQ1 Elements Life Sciences solution to automate its quality management system (QMS) and ensure compliance with industry-specific quality standards. Orchid is a worldwide provider of contract design and manufacturing for the orthopedic and medical device markets.

fda compliance solutions erp  (ISO), Federal Drug Administration (FDA), good manufacturing practices (GMP), and more. Functionality includes configurable forms and workflows, electronic signatures, audit trails, and validation scripts. The software thus significantly reduces the time required to complete and maintain regulatory compliance while providing staff with visibility to business processes, tasks, and timing.   CEBOS, a division of QAD Inc. , provides a suite of EQMS and environmental, health, and safety management (EH&S) Read More

ERP Issues for the Midsized Life Sciences Company


What makes your enterprise resource planning (ERP) requirements difficult for most vendors to satisfy? As a life sciences company, you have operational processes that set you apart from other manufacturing companies. And, your regulatory requirements, including 21 CFR part 11, aren’t like those of any other industry. The challenge is to manage compliance risks and compliance costs. Learn about an ERP compliance strategy.

fda compliance solutions erp  compliance. Compliance Strategy The FDA regulations are not a fixed target. Compliance is a key objective for any regulated company, but the requirements to meet this objective are subjective, based upon product, production processes and, perhaps most importantly, your tolerance for risk. Regulatory risk is the risk of being found out of compliance. If you accept very limited risk, your cost of compliance will be high. With more risk, compliance cost is reduced but the potential cost of non-compliance Read More

Introducing Packaged Solutions: Why Enterprise Software Customers Should Understand and Consider Packaged Solutions


Information technology (IT) projects tend to run late, over-budget, or do not meet planned goals. Implementation risk is a critical factor. Packaged solutions modularize the implementation process into smaller, well-defined units that are easier to manage and less expensive to deploy than traditional methods. This white paper discusses why enterprise software customers should consider packaged solutions.

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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. These areas include customer relationship management (CRM), accounting and financials, project accounting, distribution, manufacturing, human resources (HR), payroll, enterprise reporting, and electronic commerce. Built for the needs of an integrated enterprise, Sage 500 ERP is flexible, scalable, and fully featured to deliver a total business management solution.

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Beyond Traditional ERP: ERP Features and Functions for Engineer-to-order Manufacturers


Due to the complexity of engineer-to-order (ETO manufacturing, companies must move beyond the features typically offered by a traditional enterprise resource planning (ERP) implementation. Learn about the specific ERP features and functions that help ETO manufacturers reduce costs, shorten cycle times, and improve ordering while maintaining high quality, and discover the key steps to enhance an ETO ERP implementation.

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2011 Trends Report: Enterprise Resource Planning (ERP)


Enterprise resource planning (ERP) automates many aspects of an organization’s operations, cascading across traditional boundaries of operations, finance, manufacturing, and more. As such, changes in the ERP market can cause a ripple effect in an organization’s business. In this report, five Focus experts share eight of their 2011 predictions for ERP, so you can plan your business around these changing tides and trends.

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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 Evaluation Center. The certification seal is a valuable indicator for organizations relying on the integrity of TEC research for assistance with their software selection projects. Download this report for product highlights, competitive analysis, product analysis, and in-depth analyst commentary.

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Best Practices in Extending ERP: A Buyer’s Guide to ERP versus Best-of-breed Decisions


The trade-off between best-of-breed functionality and ease of integration is no longer so simple. Enterprise resource planning (ERP) software continues to expand, blurring the boundaries of core ERP functionality. The three essential factors to consider in ERP versus best-of-breed decisions are functionality, integration, and the ability to upgrade. Find out the questions you need to ask when considering an ERP extension.

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Justification of ERP Investments Part Three: Costs of Implementing an ERP System


Enterprise resource planning (ERP) implementation costs can be divided into one-time costs and ongoing annual costs. Both types of costs can be segmented into hardware, software, external assistance, and internal personnel. Reprinted from Maximizing Your ERP System by Dr. Scott Hamilton.

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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. The certification seal is a valuable indicator for organizations relying on the integrity of TEC research for assistance with their software selection projects. Download this report for product highlights, competitive analysis, product analysis, and in-depth analyst commentary.

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ERP Discrete Vs ERP Process


To compare process ERP solutions head-to-head based on your organization's needs and characteristics , visit TEC's process ERP evaluation center.

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IFS Applications (v. 7.5) for Discrete Manufacturing ERP Certification Report


IFS Applications (v. 7.5) is TEC Certified for online evaluation of discrete manufacturing enterprise resource planning (ERP) solutions in the ERP Evaluation Center. The certification seal is a valuable indicator for organizations relying on the integrity of TEC research for assistance with their software selection projects. Download this report for product highlights, competitive analysis, product analysis, and in-depth analyst commentary.

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