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Discrete Manufacturing (ERP)
Discrete Manufacturing (ERP)
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...
 

 gmp auditor


Will Your HACCP Foundation Crumble?
Complying with current good manufacturing processes (GMPs) is no easy task for food manufacturers. Companies that don t have a solid foundation to help with

gmp auditor  industry with focuses in GMP and FDA requirements. Searches related to Will Your HACCP Foundation Crumble? : Analysis Critical Control Point | Analysis Critical Control Point Plan | Analysis Critical Control Point System | Apply Haccp Compliance | Apply Haccp Module | Apply Haccp Principles | Apply Haccp Risk Analysis | Apply Haccp Risk Assessment | Apply Haccp Software | Apply Haccp System | Apply Quality Management System | Applying Haccp Compliance | Applying Haccp Module | Applying Haccp Principles |

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Discrete Enterprise Resource Planning (Discrete ERP) RFI / RFP Template

Financials, Human Resources, Manufacturing Management, Inventory Management, Purchasing Management, Quality Management, Sales Management, Product Technology Get this template

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Discrete Manufacturing (ERP)
Discrete Manufacturing (ERP)
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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Case Study: Align Technology, Inc.


Planning to expand, Align—a medical device manufacturer—identified electronic document management as a vital component of growth. One goal was to reduce the time needed to process change orders, as its current processes were all manual. After the vendor selection process, Align chose a change management solution that offers fully compliant and redundant protection for the company’s data. Learn more about the benefits that helped Align save $250,000 (USD) in administration costs.

gmp auditor  FDA's Good Manufacturing Practice (GMP) and the European ISO standard, Align needed two full-time staff members in document control to manage compliance. Given the company's forecasted growth, executives expected Align would need a total of four full-time employees within two years. It was abundantly clear to Yost that Align needed to migrate from its manual, paper-based documentation and change management processes to a comprehensive and automated document management system. Solution Align went through Read More

The Whys and Hows of a Security Vulnerability Assessment


TEC outlines the reasons for having a Security Vulnerability Assessment done, how a security vulnerability assessment is performed, what can be gained by enlisting the Security Vulnerability Assessment process, and what you should expect to see in a Security Vulnerability Assessment report. After all, the most important reason for having a Security Vulnerability Assessment performed is to enable corrective action. How can you know what to secure if you don't know what is insecure?

gmp auditor  Whys and Hows of a Security Vulnerability Assessment The Whys and Hows of a Security Vulnerability Assessment L. Taylor - August 9, 2000 Introduction As businesses continue putting their web-enabled e-commerce sites containing the jewels of their infrastructure online, the importance of security and privacy becomes increasingly critical. A crucial way of addressing this need to protect the company website is to conduct a Security Vulnerability Assessment. A Security Vulnerability Assessment is a risk Read More

Intentia: Stepping Out With Fashion and Style Part One: Characteristics and Trends of the Fashion Industry


So your software vendor says that they can do fashion. You better make sure that the software features go far beyond styles, colors, and sizes. The requirements for the fashion industry are some of the most demanding and unforgiving in the world of manufacturing. If you're not careful, you may find your profits falling on the cutting floor and money being swept out with the scraps.

gmp auditor  Stepping Out With Fashion and Style Part One: Characteristics and Trends of the Fashion Industry Introduction So your software vendor says that they can do fashion. You better make sure that the software features go far beyond styles, colors, and sizes. The requirements for the fashion industry are some of the most demanding and unforgiving in the world of manufacturing. If you're not careful, you may find your profits falling on the cutting floor and money being swept out with the scraps. Read on Read More

Top 10 Reasons For Having A Project Kickoff - Part I


You are about to embark on an important project. Whether the project is software or hardware related, it is a good idea to hold a project kickoff meeting. Don't miss this excellent opportunity to get across important communications and establish the tone for the project. This article discusses the 10 objectives of a project kickoff meeting, how to achieve them, and templates for presenting them. In Part I, the first three reasons are discussed but you will be left on the edge of your seat in anticipation of Parts II and III.

gmp auditor  10 Reasons For Having A Project Kickoff - Part I Top 10 Reasons For Having A Project Kickoff - Part I Featured Author - Joseph J. Strub - December 31, 2003 Introduction You are about to embark on an important project. Perhaps the project is implementing an ERP package, getting critical applications ready for the busy season, or setting up a warehouse and inventory for radio frequency operations. Whether the project is software or hardware related, it is a good idea to hold a project kickoff meeting. 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 have long embraced enterprise resource planning (ERP) and customer relationship management (CRM), but primarily use them to achieve operational efficiencies. However these systems can play a significant role in their abilities to comply with strictly FDA regulations.

gmp auditor  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 must also be verified. Written procedures (manufacturing, design, quality control, laboratory, etc.) need to be signed and dated as approved. When reviewing Device Master Record (DMR) and DHR documents, manufacturers must assure that those in use have been signed and Read More

What You Should Know Before Selecting a WMS


Before an important game, you create a game plan. Before you start building a house, you have a blueprint. And before you start looking at a warehouse management system (WMS), you must define how you want your warehouse to be organized and function. This article looks at basic warehouse strategies that need to be understood to ensure that the WMS software effectively and efficiently supports the activities of the warehouse, now and in the future. This is not to say that you will not consider the best practices of the new

gmp auditor  You Should Know Before Selecting a WMS Introduction As with any software selection process, you must establish a basic framework in which you want to operate before you start to look at package solutions. This is particularly true in evaluating a warehouse management system (WMS). Knowing how you want your warehouse to be organized and operate will assist you in selecting the most appropriate software package and what procedural changes you might need to make. In this article we examine the basic Read More

Off-shoring: Are You Getting Your Money's Worth?


Are companies that offshore software development, call center operations, and remote implementations really saving money? Are customers and users realizing benefits? Indeed, there are areas where savings can be misstated. But companies can do something to protect themselves against disappointments.

gmp auditor  shoring: Are You Getting Your Money's Worth? Introduction Every day we hear about more and more companies moving functions off-shore to places like India, the Philippines, and China. Some of you may have had firsthand experiences. The justification is that it decreases headcount, reduces labor expenses, and provides better services. But these savings are far from automatic. Whether for software development, enterprise-wide software implementations, or call center operations, companies must approach Read More

Drug Pedigree Guidelines and How Software Can Help


Drug manufacturers and retailers are tightening their data collection and reporting processes to meet new US Food and Drug Administration (USFDA) guidelines. But which software offerings are best placed to help drug manufacturers comply with the new guidelines?

gmp auditor  Pedigree Guidelines and How Software Can Help This is a modified version of the article originally published July 19, 2006. Counterfeit and adulterated drugs are an increasing problem, particularly in the United States. Not only do these activities strip profits from legitimate drug manufacturers, but they can also pose a health risk to the consumer. As a result, the US Food and Drug Administration (FDA) has issued guidelines covering cradle-to-grave tracking requirements that pharmaceutical Read More

ICICI-Infotech's North American Strategy for Success Part Two: Customer Focus and Innovative Pricing


ICICI-Infotech is starting to make its presence felt in North America and raise some ERP eyebrows. In this research note, you'll also learn about the company's strategy to target small and medium-size enterprises in order to enlarge its footprint in North America. It is targeting companies migrating from legacy systems or software that is simply out of gas.

gmp auditor  Infotech's North American Strategy for Success Part Two: Customer Focus and Innovative Pricing Introduction ICICI-Infotech has developed a well-earned and respected reputation in the Europe, Middle East, and Africa (EMEA) region of the world. Now it has set its sights squarely on the North American market. To reach this target, ICICI-Infotech has developed an intriguing strategy to attract new customers. This research note explores this strategy to assist you in determining whether ICICI-Infotech and Read More

Process Manufacturing: Industry Specific Requirements Part Three: Textiles


As with any manufacturing operation, process manufacturing has special system requirements such as formulas, unit of measure conversions, and packaging recipes. However, within the realm of process manufacturing, specific industries have needs that are more critical than others. This article explores these critical needs for the food and beverage, chemical, and a hybrid industry (textiles), so that you can focus on these requirements when evaluating enterprise-wide software.

gmp auditor  Manufacturing: Industry Specific Requirements Part Three: Textiles Introduction Traditionally, manufacturing is categorized by two methods: process and discrete. Many differences exist, but most can be grouped into two areas: those derived from material issues and those derived from production issues. Process materials are different than discrete materials. Process materials are powder, liquids or gases; they must be confined; and they are more difficult to accurately measure. Process materials are Read More

Audit Considerations for Enterprise Software Implementations Part 1: Project Planning and Management


Thanks, in part, to the fallout from the financial scandals of Enron, WorldCom, Tyco and others, the corporate spotlight is being refocused on the audit function. However, by waiting until systems are live and in production before applying an audit regimen, you may miss an excellent opportunity to establish effective controls at the outset, when the enterprise software is being implemented. Read on to learn where and how, as an executive sponsor, project manager, or team member, you can instill audit procedures that can continue throughout the life of the software.

gmp auditor  Considerations for Enterprise Software Implementations Part 1: Project Planning and Management Introduction Recent scandals in the corporate world have created a refreshed awareness of the audit function. A direct by-product of these scandals is the Sarbanes-Oxley Act of 2002 (SOX), which gives legal and financial muscle to the assurance of the integrity, reliability, and accuracy of financial reporting and corporate disclosures. In fact, based on a recent survey of CFO's and IT executives, 71 percent Read More

Traffic Audits Make Strange Bedfellows: Part II - The Audit Process


With traffic being the lifeblood of an e-commerce site the Marketing crew knows that the traffic numbers are going to be audited. And they look to the CIO to make sure that the numbers will pass muster. If there’s a problem with the numbers, the CIO may be blamed. So it’s important to understand what auditors want to see, and to make sure that your collection and reporting procedures are appropriate. The greatest danger is having to restate numbers that you’ve already provided to advertisers.

gmp auditor  Audits Make Strange Bedfellows: Part II - The Audit Process This is Part II of a two part article. Part I : The Why's and What's of Auditing Part II : The Audit Process What's in an audit? The audit is a process for verification of the numbers that you report to your advertisers. Audits can be performed in a number of different ways. Server-based audits examine data that is available at the server, most importantly traffic logs and web logs. An auditing organization will prowl through the logs to ch Read More

Top 10 Reasons For Having A Project Kickoff - Part III


You are about to embark on an important project. Whether the project is software or hardware related, it is a good idea to hold a project kickoff meeting. Don’t miss this excellent opportunity to get across important communications and establish the tone for the project. This article discusses the 10 objectives of a project kickoff meeting, how to achieve them, and templates for presenting them. In Part III, we complete the discussion of the remaining four reasons, which can be even more critical to beginning a project on a positive note and reaching a successful completion.

gmp auditor  10 Reasons For Having A Project Kickoff - Part III Top 10 Reasons For Having A Project Kickoff - Part III Featured Author - Joseph J. Strub - January 2, 2004 Introduction You are about to embark on an important project. Perhaps the project is implementing an ERP package, getting critical applications ready for the busy season, or setting up a warehouse and inventory for radio frequency operations. Whether the project is software or hardware related, it is a good idea to hold a project kickoff meeting. Read More

ERP and SCM Implementations Part Two: Interfaces and Priorities


To a large extent, software packages do work out of the box. Packages that do not perform perfectly or as users would expect is when dissatisfaction arises. These can be dealt with in a rational manner through the employment of effective project and change management procedures. However, an area that typically creates problems, whether expected or not, is the development of interfaces between proprietary software that cannot be replaced.

gmp auditor  and SCM Implementations Part Two: Interfaces and Priorities Interfaces To a large extent, software packages do work out of the box. Packages that do not perform perfectly or as users would expect is when dissatisfaction arises. This dissatisfaction can be dealt with in a rational manner through the employment of effective project and change management procedures. However, an area that typically creates problems, whether expected or not, is the development of interfaces between proprietary software that Read More