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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. 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 requirement


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

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...
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

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...
QAD Raises the Blended Cloud/On-premise ERP Bar
QAD is a leading provider of enterprise applications for several thousand global manufacturing companies specializing in automotive, consumer products

fda requirement  worked with a US FDA certification agent to get approved, and it has a letter stating that it offers a qualified environment. In other words, the qualification letter states that QAD software and procedures meet the strict FDA regulations. Each customer still has to get its internal procedures certified, but the company doesn’t have to worry about getting its systems and IT procedures documented and certified, which is a huge time and money saver. Life sciences customers also like the on-demand 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

fda requirement  to ascertain compliance with FDA quality regulations. The secure file must be fully accessible and non-alterable. The traceability requirement should not be confused with the tracking regulation under FDA’s 21 CFR 821. The tracking regulation requires certain devices to be tracked to the end user or patient through the entire distribution process. Components of a device subject to traceability requirements must be identified with a control number where appropriate. Therefore, in selecting an ERP Read More...
Remote Access to SourceSafe (100 Times Faster)
Remote access to source code is a requirement for today’s development teams. Popular source control packages are ideal for sharing code across a local area

fda requirement  Access to SourceSafe (100 Times Faster) Remote access to source code is a requirement for today’s development teams. Popular source control packages are ideal for sharing code across a local area network (LAN), but when used remotely over the Internet, they cause problems in performance, security, and flexibility. Find out how remote-access middleware does more than increase your network speed. It can protect your code base and provide multiplatform support. Read More...
Success Keys for Proposal Automation
Proposal writing has become a common requirement throughout the entire business world. And for many sales people, they are a necessary evil. If you're thinking

fda requirement  Keys for Proposal Automation In today's economy, sales people have to write more proposals, and better proposals, than ever before. As the industry has become more competitive and complex, customers have become both more confused and more demanding. As a result, they are likely to listen to a presentation, nod their heads, and mutter those dreaded words, Sounds good! Why don't you put that in writing for me? Why Do Customers Want Proposals? Writing proposals is about as much fun as having your Read More...
Expandable Case Study: Thermage, Inc.
After receiving US Food and Drug Administration (FDA) approval for its ground-breaking product, medical technology startup Thermage, Inc., was looking to

fda requirement  up production and maintain FDA compliance. Read More...
Key Factors for Achieving Successful Projects
No matter how unique a project may be, project quality is always the top concern for both the software services providers and the clients—on time and within

fda requirement  Factors for Achieving Successful Projects Key Factors for Achieving Successful Projects If you receive errors when attempting to view this white paper, please install the latest version of Adobe Reader. We remain committed to timely and practical solutions that fulfill expectations. Each step of the way matching the delivery of service to the culture of the client. Source : Certellus LLC Resources Related to Key Factors for Achieving Successful Projects : Program Management (Wikipedia) Key Factors Read More...
“E.T.O. Phone Home”: Using Discrete ERP in an ETO Environment Will Leave You with an Out-of-this-world Experience
A brief journey of what functionality ERP engineer-to-order systems must support.Just like the mythical character in the film E.T., who was far from home in

fda requirement  T.O. Phone Home”: Using Discrete ERP in an ETO Environment Will Leave You with an Out-of-this-world Experience A brief journey of what functionality ERP engineer-to-order systems must support. Just like the mythical character in the film E.T., who was far from home in an unfamiliar environment, companies that have years of experience working with a discrete ERP system sometimes feel that they are out of this world in trying to adapt the system to the unique elements  in the engineer-to-order (ETO) Read More...
The Role of Sales Training Requirements Definition and Requests for Proposals in the Success of Technology Companies
The first step in choosing an effectiveness service provider (ESP) that best meets your company's needs is to develop a requirements definition. When used as a

fda requirement  Role of Sales Training Requirements Definition and Requests for Proposals in the Success of Technology Companies Introduction Sales training is a critical component contributing to the success of most technology companies. For sales and training executives and managers, assessing and selecting from among the many sales training and methodology providers can be a daunting task. However, sales training is a significant (and, from a financial reporting standpoint, often a financially material ) Read More...
How Carolina Color Chose abas ERP
Abas-USA recently announced that Carolina Color Corporation has chosen abas Business Suite for its future planned growth and business. Carolina Color provides

fda requirement  Carolina Color Chose abas ERP Abas-USA recently announced that  Carolina Color Corporation has chosen abas Business Suite  for its future planned growth and business. Carolina Color provides accurate matching services and eco-friendly, proprietary colorant solutions for unique customer applications. Carolina Color reportedly started an enterprise resource planning (ERP) selection process in 2007 to replace a homegrown system. Abas was invited to participate and was shortlisted with two 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

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...

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