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Software Functionality Revealed in Detail
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 fda requirement


Complying with US FDA Title 21 CFR Part 11 for the Life Sciences Industry
Compliance with US FDA regulations is a market requirement. Thus, among the nearly 1,500 installations of mySAP ERP software among pharmaceutical, medical

fda requirement  with US FDA Title 21 CFR Part 11 for the Life Sciences Industry Compliance with US FDA regulations is a market requirement. Thus, among the nearly 1,500 installations of mySAP ERP software among pharmaceutical, medical diagnostics and devices, and biotechnology companies worldwide, it is vital to be aware of the functions and features of mySAP ERP that demonstrate technical compliance with US FDA 21 CFR Part 11 Electronic Records; Electronic Signatures; Final Rule.

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Software Functionality Revealed in Detail

We’ve opened the hood on every major category of enterprise software. Learn about thousands of features and functions, and how enterprise software really works.

Get free sample report
Compare Software Solutions

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

Compare Now

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

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

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Documents related to » fda requirement

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 quality control procedures, audit trails, and product traceability and recall are at an even greater disadvantage. Find out how an enterprise resource planning (ERP) solution can help with food safety compliance—so it's your cookie that crumbles, not your foundation.

fda requirement  Fault Tree Analysis | FDA Haccp | Food Analysis | Food and Drug Administration | Food Development Centre | Food Handling | Food Hazard Analysis | Food Hygiene | Food Hygiene Course | Food Hygiene Training | Food Microbiology | Food Quality | Food Quality Control | Food Safety | Food Safety | Food Safety and Sanitation | Food Safety Audit | Food Safety Audits | Food Safety Consultancy | Food Safety Consultant | Food Safety Consultants | Food Safety Hazard | Food Safety Management | Food Safety Management Read More

Fighting Terrorism with Global Trade Management


The challenge for government and industry is to secure trade without impeding growth. Therefore, there is a greater need for timely information updated by knowledgeable sources of compliance and regulation issues. Global trade management software appears to be the best solution.

fda requirement  to be made to FDA within four hours; and prior notice of food import shipments before allowed entry to the US Patriot Act of 2002 This Act, signed into law by the US president, requires that financial institutions know their customers and, to the greatest extent possible, their customers' customers. (Source: TradeBeam ) One should notice a multitude of complex interactions between the global trade flows within a secure supply chain. Namely, across few dozens of required pertinent processes, global trade Read More

Process Manufacturing: Industry Specific Requirements Part One: Introduction


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.

fda requirement  a request from the FDA. Furthermore, recallability implies isolating and locating the defective product to an absolute minimum with dead-on certainty. To achieve this objective, bullet proof lot and sublot tracking is needed. This is easier said than done and can be an extremely time consuming process. However, certain attributes of lot/sublot tracking in the software can expedite the recording and tracking functions and help to eliminate damaging fallout. First, there is lot to sublot inheritance. Read More

Food Safety, Government Regulations, and Brand Protection


Many food companies are investing significant funds in building awareness for their brands in the market, which can pay off amply in competitive, commodity markets. One highly publicized recall, however, can turn an established brand asset into a liability.

fda requirement  producers regulated by the FDA and USDA have thus implemented hazard analysis and critical control points (HACCP) programs to standardize their practices in food quality and safety, thereby streamlining the business processes and reducing the risks of noncompliance, while keeping operational costs down as much as possible. The two markets with the most impact worldwide are the US and the European Union (EU), given that they are among the largest, and are major importers and exporters of food. The US Read More

Security in the Software Development Lifecycle


Application security is an important emerging requirement in software development. This article introduces CLASP, an application security process and plug-in to IBM 's Rational Unified Process environment. It was developed by Secure Software, and gives organizations a structured way to address security concerns during the software development lifecycle.

fda requirement  in the Software Development Lifecycle Application security is an important emerging requirement in software development. This article introduces CLASP, an application security process and plug-in to IBM 's Rational Unified Process environment. It was developed by Secure Software, and gives organizations a structured way to address security concerns during the software development lifecycle. Read More

Profiting from PCI Compliance


Although the Payment Card Industry Data Security Standard (PCI DSS) has become a global requirement, many organizations are lagging in compliance. For many companies, regulatory compliance can already be an overwhelming and confusing area to navigate, and the need to comply with the PCI DSS might feel like yet another burden. Discover the efficiency gains of building a strategy designed around PCI compliance.

fda requirement  pci dss security,pci dss compliant,pci dss requirements,regulatory compliance audit,hipaa data security,pci dss standard,payment card industry pci data security,pci data security standards,data security control,data security policies,data security audit,it regulatory compliance,pci dss assessment,pci dss audit,pci dss level Read More

PI for Microsoft Dynamics AX


Designed for midsize and larger companies, Microsoft Dynamics AX is a multi-language, multi-currency enterprise resource planning (ERP) application that empowers people to work effectively, manage change, and compete globally. It makes it easier to operate across locations and countries by standardizing processes, providing visibility across your organization, and helping to simplify compliance. Fullscope has developed additional solutions that complement the Dynamics AX ERP solution and solve specific challenges or industry needs including process industry functionality for food, beverage, chemical, life sciences, and pharma companies; data collection; and FDA validation and compliance.

fda requirement  companies; data collection; and FDA validation and compliance. Read More

Simple Analytics


Simple Analytics is a data analytics solutions and services company, formed in 2013. With data science capability and competence becoming a minimum requirement in areas which have not traditionally been thought of as data-focused industries, the company's approach is to provide turn-key solutions and services that maximize ROI and can be implemented rapidly without straining IT investments. Simple Analytics provides consultancy, technical support, and training on big data, predictive analytics, prescriptive analytics, prospective analytics, data sciences, and mobility.

fda requirement  Analytics Simple Analytics is a data analytics solutions and services company, formed in 2013. With data science capability and competence becoming a minimum requirement in areas which have not traditionally been thought of as data-focused industries, the company's approach is to provide turn-key solutions and services that maximize ROI and can be implemented rapidly without straining IT investments. Simple Analytics provides consultancy, technical support, and training on big data, predictive analyt Read More

E-procurement RFI/RFP Template


Buying Entity Features, Selling Entity Features, Consulting services, Marketplace, Asset Management, Product Technology

fda requirement  procurement RFI/RFP Template The E-procurement RFI/RFP Template lists and describes 1919 features and functions found in E-procurement software solutions. This Template can help you save time, control costs, and communicate clearly with vendors at nearly every stage of your E-procurement software selection projects. Features and functions included in this Template: Buying Entity Features Selling Entity Features Consulting services Marketplace Asset Management Product Technology   This functional and Read More

Performance Management: An Ex-Industry Analyst's View


This white paper reviews the need for broader financial management solutions that enable the finance function to deliver greater transparency and visibility of business information. It also covers the growing requirement to improve both the efficiency of financial management and reporting processes, whilst at the same time maximizing the effectiveness of corporate performance activities.

fda requirement  Management: An Ex-Industry Analyst's View This white paper reviews the need for broader financial management solutions that enable the finance function to deliver greater transparency and visibility of business information. It also covers the growing requirement to improve both the efficiency of financial management and reporting processes, whilst at the same time maximizing the effectiveness of corporate performance activities. Read More

HCIMS - Pharmacy Management RFI/RFP Template


Product Functionality, HCIMS - Pharmacy Management, Privacy and Security, and Product Technology

fda requirement  - Pharmacy Management RFI/RFP Template The HCIMS - Pharmacy Management RFI/RFP Template lists and describes 880 features and functions found in HCIMS - Pharmacy Management software solutions. This Pharmacy Management Template can help you save time, control costs, and communicate clearly with vendors at nearly every stage of your HCIMS - Pharmacy Management software selection projects. Features and functions included in this Pharmacy Management Template: Product Functionality HCIMS - Pharmacy Read More

Compliance and Privileged Password Management


Today’s increasing compliance requirements have focused additional attention on how enterprises manage and control these critical accounts and passwords. How can you address the requirement for shared privileged access while still maximizing information security? Find out how traditional solutions may not be providing the security you need—and how upgrading your password system with an automated solution can help.

fda requirement  and Privileged Password Management Today’s increasing compliance requirements have focused additional attention on how enterprises manage and control these critical accounts and passwords. How can you address the requirement for shared privileged access while still maximizing information security? Find out how traditional solutions may not be providing the security you need—and how upgrading your password system with an automated solution can help. Read More

Software Outsourcing Service


Depending on customers' needs, HopeRun provides offshore software outsourcing using a number of different models, including application development, QA, software localization, and operation support and maintenance. HopeRun provides application development in its complete cycle from business requirement analysis, design, development, testing, delivery, and up to post-production maintenance. Due to the company's strict compliance to CMMI3, HopeRun guarantees its development cycle follows industry standards and its final deliverables are of high quality. For customers in need of outsourcing QA processes or expanding their existing QA teams, HopeRun has a team of QA specialists. The company's service includes regression testing, performance testing, test case design, and automated test scripts. HopeRun's QA team can take advantage of the potential time zone difference and provide overnight QA services to its customers. If a company's software products are written in English or Japanese and are ready to be marketed in other languages such as Chinese, HopeRun provides localization service to make those products ready for the global market. Finally, with engineers experienced in a wide range of platforms such as Windows Servers, Unix, and Linux, HopeRun provides daily operation support and maintenance of customers' existing systems. Because of the potential time zone difference, HopeRun can perform maintenance tasks at late hours for its customers.  

fda requirement  Outsourcing Service Depending on customers' needs, HopeRun provides offshore software outsourcing using a number of different models, including application development, QA, software localization, and operation support and maintenance. HopeRun provides application development in its complete cycle from business requirement analysis, design, development, testing, delivery, and up to post-production maintenance. Due to the company's strict compliance to CMMI3, HopeRun guarantees its development cycle Read More