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 erp fda compliance expectations


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

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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

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 requirements needs, as well as product related components of environmental health and safety (EH&S). 

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Documents related to » erp fda compliance expectations

Do You Need a State-of-the-art ERP Solution?


As your company grows, you must continually evaluate whether your work processes and IT solutions can solve your problems and help grow your business. By performing a gap analysis, you can look at where your business is headed and whether you have the right tools to get there. This white paper can help you perform a preliminary gap analysis to determine whether you need to upgrade your IT solutions and business processes.

erp fda compliance expectations  compliance processes. Because an ERP system centralizes data management, it can minimize reporting costs by providing a convenient and efficient way to gather and monitor relevant information and eliminate manual procedures across your business processes, whether accounting, manufacturing, services, distribution, or point of sale. Does your existing technology integrate the capabilities necessary to improve your regulatory compliance? Complete the following checklist to find out. Lot traceability —Lot Read More

Ability 585 ERP Is Now TEC Certified


In a recent live demo session with enterprise resource planning (ERP) software vendor Ability, I had the chance to get an in-depth look at Ability 585 ERP. It’s not every day that a product’s capabilities exceed my expectations, but this was the certainly the case with Ability 585 ERP, which is now TEC Certified for ERP for Manufacturing (SMB). Ability’s core principle is to provide

erp fda compliance expectations  585 ERP Is Now TEC Certified In a recent live demo session with enterprise resource planning (ERP) software vendor Ability, I had the chance to get an in-depth look at Ability 585 ERP. It’s not every day that a product’s capabilities exceed my expectations, but this was the certainly the case with Ability 585 ERP, which is now TEC Certified for ERP for Manufacturing (SMB) . Ability’s core principle is to provide ERP software that is powerful yet affordable for manufacturers of small or 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.

erp fda compliance expectations  all areas of the ERP system that are FDA significant, including batch records, engineering changes, quality records, inventory status transactions, process instructions and recording of results. The infrastructure approach gives the business control over its approach to compliance. For example, a hard-coded compliance solution might require an electronic signature when signing off on a data entry to a batch record, even if the business keeps a paper batch record. The Merit solution infrastructure 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 choosing the best vendor for you are critical to a successful ERP implementation. As a decision maker, you need to quickly identify your ERP requirements, effectively communicate these needs to vendors, and successfully compare various product alternatives. Learn how.

erp fda compliance expectations  all aspects of the ERP market, and get insight into specific areas of interest. Source: Focus Research Resources Related to ERP Systems Buyer's Guide : Enterprise Resource Planning (ERP) (Wikipedia) ERP Systems Buyer's Guide ERP Systems is also known as : Enterprise Resource Planning System , ERP Systems Buyer Guide , ERP System Purchase Process , ERP Implementation , ERP Modules , ERP Solution , ERP Packages , Cost of an ERP System , ERP Software , Customization of ERP System , ERP System Product Read More

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.

erp fda compliance expectations  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. Read More

Justification of ERP Investments Part Four: Replacing or Re-implementing an ERP System


An investment analysis focusing on enterprise resource planning (ERP) benefits frequently applies to those firms initially justifying an ERP implementation. It can also be used to justify a 're-implementation' when the initial efforts have failed to produce desired results. Reprinted from Maximizing Your ERP System by Dr. Scott Hamilton.

erp fda compliance expectations  of ERP Investments Part Four: Replacing or Re-implementing an ERP System Replacing or Re-implementing an ERP System* An investment analysis focusing on enterprise resource planning (ERP) benefits frequently applies to those firms initially justifying an ERP implementation. It can also be used to justify a re-implementation when the initial efforts have failed to produce desired results. The box describing Classifications of ERP success identifies situations where the ERP implementation fal Read More

IFS Applications


Developed using open, component-based technology, IFS Applications provide extended enterprise resource planning (ERP) functionality, including customer relationship management (CRM); supply chain management (SCM); product lifecycle management (PLM); corporate performance management (CPM); enterprise asset management (EAM); and maintenance, repair, and overhaul (MRO) capabilities. IFS Applications' service-oriented architecture (SOA) is designed to help companies collaborate with partners, suppliers, and customers. IFS Applications are a comprehensive business system for midsize and large organizations. In addition to the processes that are supported by all business systems, such as finances, inventories, traditional manufacturing, and customer management, IFS Applications support the entire lifecycle of products from construction to maintenance and aftermarket services.  

erp fda compliance expectations  IFS Applications provide extended enterprise resource planning (ERP) functionality, including customer relationship management (CRM); supply chain management (SCM); product lifecycle management (PLM); corporate performance management (CPM); enterprise asset management (EAM); and maintenance, repair, and overhaul (MRO) capabilities. IFS Applications' service-oriented architecture (SOA) is designed to help companies collaborate with partners, suppliers, and customers. IFS Applications are a comprehensive Read More

Justification of ERP Investments Part 1: Quantifiable Benefits from an ERP System


Studies that surveyed manufacturers about the impact of ERP systems on firm performance indicate that company size and industry do not affect the results. Benefits have been indicated for large and small firms, whether they make standard or custom products or are in discrete or process manufacturing environments. This section explains the quantifiable benefits in terms of several areas of improvement. Reprinted from Maximizing Your ERP System by Dr. Scott Hamilton.

erp fda compliance expectations  of ERP Investments Part 1: Quantifiable Benefits from an ERP System Originally published - February 13, 2004 Justification of ERP Investments* The expected return on investment provides the cost justification and motivation for investing in ERP. There are quantifiable benefits as well as intangible benefits in the ERP investment decision. The quantifiable benefits have a bottom-line impact on profitability, asset turnover, and a potential effect on stock value. This section discusses the Read More

Pronto Xi Dimensions


PRONTO-Xi is an enterprise resource planning (ERP) solution designed to help companies maintain visibility over the extended enterprise—including field sales and technical staff—and closely manage the entire supply chain. It includes a business intelligence (BI) analytics tool that can help employees analyze data, interpret trends, and make decisions based on the most up-to-date information. PRONTO-Xi includes fully integrated business functionality covering: accounting, sales orders (SOs) and purchase orders (POs), customer relationship management (CRM), warehouse management systems (WMS), electronic data interchange (EDI), retail point-of-sale (POS), facilities management (FM), manufacturing resource planning (MRP), supply chain management (SCM), and other related functions. PRONTO-Xi runs on a variety of hardware platforms and operating systems (OSs), and includes built-in mobile and Internet technology.

erp fda compliance expectations  Dimensions PRONTO-Xi is an enterprise resource planning (ERP) solution designed to help companies maintain visibility over the extended enterprise—including field sales and technical staff—and closely manage the entire supply chain. It includes a business intelligence (BI) analytics tool that can help employees analyze data, interpret trends, and make decisions based on the most up-to-date information. PRONTO-Xi includes fully integrated business functionality covering: accounting, sales orders (SOs) Read More

Are ERP Workarounds a Terrific Way of Shooting Yourself in the Foot?


Are ERP workarounds a terrific way of shooting yourself in the foot? TEC Analyst Gabriel Gheorghiu says “There’s no way to avoid ERP workarounds. And yes, they’re a problem.” TEC Analyst Jorge García says “No they’re not.” Managing Editor David Clark attempts to moderate (just a wee bit too late).

erp fda compliance expectations  ERP Workarounds a Terrific Way of Shooting Yourself in the Foot? * TEC Analyst Gabriel Gheorghiu says “There’s no way to avoid them. And yes, they’re a problem.” TEC Analyst Jorge García says “No they’re not.” * Gabriel Gheorghiu, TEC Analyst Here’s an example of a typical ERP workaround: You need a field for purchase order types (you would be surprised how many ERP systems don’t have this) in order to differentiate between purchasing raw materials, assets, office accessories, etc. Read More

Dynacom ERP (v. 11.3) for ERP for SMB Certification Report


Dynacom Enterprise is now TEC Certified for online evaluation of enterprise resource planning (ERP) for small to medium business (SMB) 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.

erp fda compliance expectations  ERP (v. 11.3) for ERP for SMB Certification Report Dynacom Enterprise is now TEC Certified for online evaluation of enterprise resource planning (ERP) for small to medium business (SMB) 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 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-wide, improve efficiency throughout the enterprise, and manage costs. In this guide, you’ll find details on what to look for in a midmarket ERP package, the benefits it should bring to your midsize company, and what you need to know before you commit to a solution.

erp fda compliance expectations  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-wide, improve efficiency throughout the enterprise, and manage costs. In this guide, you’ll find details on what to look for in a midmarket ERP package, the benefits it should bring to your midsize company, and what you need to know before you commit to a solution. Read More