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 fda guideline


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 guideline  , FDA Compliant , FDA Guideline , FDA Guidelines , FDA Label Compliance , FDA Medical Device Compliance , FDA Regulatory Compliance , FDA Requirements , Food and Drug Administration FDA , Medical Regulatory Compliance , Regulatory Compliance , Regulatory Compliance Software , FDA Policy , FDA Compliance Consulting . While every manufacturer in the United States is subject to a multitude of governmental rules and regulations, probably no industries are as fully regulated as those dealing with

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Documents related to » fda guideline

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

fda guideline  vertical industries, such as FDA-regulated products, and furniture and exhibition equipment manufacturing, as well as services. Still, the software development process at Ability is organized in a way that depends to a large extent on opinions and input from people who use the software every day on the shop floor and other departments. It’s built around their needs instead of the traditional software approach, where ERP companies push their own ideas on technical issues and user interface down to the Read More

Oracle Renders Its PLM Outline Part One: Event Summary


Although its PLM solutions will not likely be the "all things to all people" any time soon, Oracle might be showing us its ability to develop its own applications in collaborative effort with its prominent customers.

fda guideline  Food and Drug Administration's [FDA] 21 CFR Part 11 regulation), Health Insurance Patient Portability Act (HIPAA), a guideline for managing patient information, and Sarbanes-Oxley Act (SOA), the new legislation for accounting procedures, while the Oracle Financials suite also now leverages eXtensible Business Reporting Language (XBRL), and XML-based standard for financial reporting. Also, rather than traditionally delivering a horizontally broad and functional product and relying on its technically savvy 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?

fda guideline  Guidelines? Simply stated, the FDA's pedigree guidelines require data to be captured at each stage of the production and distribution process, until the drugs reach the customer or end user. The players principally affected by the guidelines are pharmaceutical manufacturers, drug distribution companies, drug wholesalers, and drug retailers. From the manufacturer's perspective, the guidelines essentially require pharmaceutical companies to maintain data on each case of drugs leaving the shipping dock. Read More

QAD Explore 2012: Only Good Things Can Come from Talking to the Customer


As a seasoned provider of enterprise applications for manufacturing companies, QAD knows the importance of listening to its clients. In fact, the company has created a customer engagement program to help its customers align their business processes to their strategic business goals. Get the details on this program, as well as a full update from the QAD Explore 2012 user conference in P.J. Jakovljevic’s latest article.

fda guideline  Food and Drug Administration (FDA), 21 CFR Part 11, International Financial Reporting Standards (IFRS) At the Roadmap phase, QAD’s team present a detailed plan for the deployment of the agreed-upon set of recommendations for a detailed work plan, resource requirements, change management control processes, and knowledge transfer. The implementation starts with QAD Easy On Boarding (EOB)— which follows industry best practices and QAD’s expert knowledge of implementing ERP solutions with preconfigured Read More

A Focused Web-based Solution for Chemicals, Drugs, and Mill-based Industries


SSI shows deep understanding of the requirements for chemical, drug, and mill-based industries. Consequently, it has developed such must-have capabilities as potency controls, container movements, top-down and bottom-up traceability, and controls for customs and excise, shelf life, and location validation.

fda guideline  authorities such as the FDA in the US; Hazard Analysis Critical Control Points (HACCP) in Canada; the Medicines and Healthcare products Regulatory Agency (MHRA), Her Majesty's Revenue & Customs (HM C&E), Control of Substances Hazardous to Health Regulations (COSHH), and the Food Standards Agency (FSA) in the UK; Health and Safety Statutory Instruments in Ireland; and European Food Safety Inspection Service ( EFSIS )/ British Retail Consortium (BRC) standards. (EFSIS is a premier third-party independent Read More

New Arena PLM Offering Handles Quality


Cloud-based PLM software provider Arena Solutions recently announced Arena Quality, a new solution that aims to better organize quality processes at high-tech companies. Quality processes are now directly connected to the product record in Arena PLM, which provides everyone with visibility into quality issues to rapidly identify, capture, collaborate, and resolve product quality problems.

fda guideline  audit ready for ISO, FDA, and other regulatory organizations. A complete history of quality processes, down to field level edits, can be captured in Arena Quality. The product is configured to enable anyone within the company to flag a quality issue, so companies who have adopted a Kaizen approach can use it to the fullest.   Arena customers have used Arena PLM to control their product designs and collaborate with their supply chains for nearly a decade. Now, Arena Quality provides template-based Read More

VAI Explains Its (Quiet) Success in a Hotly Contested ERP Market -- Part 1


Despite my nearly two decades of covering the enterprise resource planning (ERP) market, every now and then I am still surprised to come across a lesser known and yet well run ERP software player. One such vendor is VAI (Vormittag Associates Inc.)--an award winning software developer and an IBM Premier Business Partner. Founded in 1978, VAI is headquartered on Long Island, New York, with US branch

fda guideline  comply with the US FDA Food Safety Regulations for recall tracking, the so-called  Food Safety Modernization Act (FMSA) , make the need for technology ever present. For its part, S2K Warehouse has been a good door-opening product. Many businesses with installed ERP solutions are looking solely for Warehouse Management and this standalone product that can interface to their current ERP vendor gets the vendor into many companies that may eventually move to VAI’s full ERP suite. For VAI’s installed Read More

Five Must-have ERP Features for Medical Device Manufacturers


In the medical device manufacturing industry, errors can cost more than money—they can cost lives. In order to meet safety regulations, manufacturers are turning to enterprise resource planning (ERP) solutions. Discover the five features any medical device manufacturer should look for in an ERP system in order to meet compliance requirements, produce high-quality products, operate efficiently, and maximize profitability.

fda guideline  of regulations such as FDA regulations 21 CFR 820 Quality System Regulation (QSR) and 21 CFR Part 11, along with ISO regulations ISO 9001 and ISO 13485:2003. Not only do today's solutions help manufacturers meet these mandates, they enable the highest levels of quality, productivity and profitability. Bringing the Best ERP Solution to the Medical Device Industry Today's ERP software can capture data, validate manufacturing processes, ensure product specifications are met, and provide rapid access to that Read More

Enterprise Intelligence Tools Tame Business Knowledge Glut


Skila, Inc. is applying advanced eKnowedge tools to the pharmaceutical, biotechnology, and medical device industries. It’s the kind of offering every knowledge worker wants to have.

fda guideline  as the SEC, the FDA and the Patent Office, proprietary news from licensed sources like Lexis-Nexus and Dialog, and pay-per-view and subscription sources like Medline. They also have a technology called Intelligration that combines and synthesizes all of these external data, as well as relevant data from the company's own databases. This synthesis produces a database, called the Intellibase, that provides concise views of actionable data. Finally, underlying both of these is a carefully crafted 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 guideline  be an opportunity. The FDA is permitting manufacturers to benefit from emerging technologies to streamline record keeping and compliance. This technology can increase the usability of the information gathered by integrating both business processes and audit functions, without compromising the quality of regulatory compliance. The opportunity can be significant. Life Science companies should see Part 11 as an opportunity to improve business practices. Benefits may include: Lowered cost of data collection Read More

Process-based Governance, Risk Management, and Compliance


The right balance of automated processes with paper records and manual, human interaction is necessary to keep costs under control with a flexible yet controlled set of procedures. The strategic software category, governance, risk management, and compliance, is poised to help.

fda guideline  paper by Olin Thompson, FDA Compliance for the Life Sciences ). In any organization, evaluation of the characteristics of operations, products, and so forth will reveal the mix of standard versus exceptional circumstances. The most effective procedures will allow computer systems to assist in repetitive operations. At the same time, computers can integrate manual or semi-manual approaches to exceptions, which should be captured in a digital form to facilitate the storing and retrieving of documents, Read More

Don’t Let Wireless Detour Your PCI Compliance


The Payment Card Industry Security Standards Council (PCI SSC) has published a PCI DSS Wireless Guideline which acknowledges that wireless is a clear and present danger to network security and those who collect, store or transmit card holder data must take steps to assure that it is secure, whether or not wireless is deployed in the cardholder data environment. Organizations that handle payment card data must take steps to secure the CDE against wireless threats including unmanaged and unknown wireless devices in the environment and must scan all locations. This white paper helps organizations understand how the PCI DSS 1.2 wireless requirements apply to them, how to meet those requirements in a cost effective way, and how to secure your network and cardholder data from wireless threats.

fda guideline  Let Wireless Detour Your PCI Compliance The Payment Card Industry Security Standards Council (PCI SSC) has published a PCI DSS Wireless Guideline which acknowledges that wireless is a clear and present danger to network security and those who collect, store or transmit card holder data must take steps to assure that it is secure, whether or not wireless is deployed in the cardholder data environment. Organizations that handle payment card data must take steps to secure the CDE against wireless Read More

Why Life Sciences Companies Should Engage on Social Media


While most industries are rapidly adopting social media to engage with customers, the life sciences companies remain typically balk at extending social presence in a highly regulated environment. In view of recent Food and Drug Administration (FDA) guidelines on the responsibilities of life sciences companies monitoring social media, this paper intends to assist life sciences companies in determining the scope and potential impact of creating a social media engagement program.

fda guideline  Food and Drug Administration (FDA) guidelines on the responsibilities of life sciences companies monitoring social media, this paper intends to assist life sciences companies in determining the scope and potential impact of creating a social media engagement program. Read More

TEC Industry Watch: Enterprise Software News for the Week of May 21st, 2012


SOFTWARE SELECTED, IMPLEMENTED, AND PUT TO GOOD USEHorticultural tools distribution business goes live with Sage ERP X3 Industry tags: wholesale and retail trade "The 127-year-old company A.M. Leonard, which currently operates mostly via catalog and Internet commerce, selected Sage ERP X3 to replace its aged legacy system. The Sage product was chosen mainly because of its rich functionality and

fda guideline  SYSPRO ERP compliant with FDA Food Safety Modernization Act Industry tags: food and beverages The new FDA rules mainly cover the traceability of lot and shelf life dates in goods shipments, recalls, and receiving. Their purpose is to move manufacturers from post-factum reaction to potential food contamination to its proactive prevention. As SYSPRO announced that its ERP software is now fully compliant with the new regulations, it gives them an additional competitive advantage. —Aleksey Osintsev, TEC Read More