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Sparta Systems Outlines Tips and Tactics to Prepare for eMDR Mandate
(Sparta Systems: Holmdel, NJ) -- Sparta Systems Inc., the maker of TrackWise software and the market leader in enterprise quality and compliance management solutions, has outlined its recommendations to help companies prepare for electronic Medical Device Reporting (eMDR), the expected regulation…
Electronic Medical Records Help Reduce Medical Errors
(GE: Fairfield, CT) – GE announced, as part of its healthymagination initiative to increase technology access and reduce costs, the launch of Stimulus Simplicity, a program offering doctors and hospitals an easier path to electronic medical records (EMR) adoption. This program, a joint offering of…
NQF Endorses Six New Practices for Laboratory Medicine
(NAHQ: Gleview, Illinois) -- To improve the safety of laboratory medicine, the National Quality Forum (NQF) has endorsed six preferred practices for measuring and reporting patient safety and communication in laboratory medicine. The preferred practices focus specifically on improving quality…
Going Low Profile in Afghanistan
This is the second report from the author, who is currently working in Afghanistan. Don’t miss his first article, “Ensuring Quality in a War Zone.”  --Editor They told us the road was clear. They didn’t say it was safe; it was a dirt road that ran seven kilometers through the district of Shah…
Web Site Describes 3-D Point-Cloud Applications
(Innovmetric: Québec, Canada) -- The growing popularity of 3-D digitizers, such as laser scanners, white-light digitizers, portable CMMs, and laser trackers, has opened the door to a wide array of new applications in the manufacturing world. These new tools have helped thousands of companies to…
Product Announcement: EtQ Adds Graphical Decision Tree to Reliance 6.2
(EtQ: Farmingdale, New York) -- The EtQ decision tree allows users to create a web-based list of related questions that are dependant on each other, so that the results of the questions will impact the business process and produce quantitative results such as a risk ranking, subsequent questions,…
Survey Shows Effect of Economy on Manufacturers
(MFGWatch: Atlanta) -- Results of a survey recently conducted by MFGWatch give a snapshot on the state of sourcing, sourcing preferences, company growth projections, and reactions to economic conditions. More than 200 purchasing professionals and engineers from the manufacturing industry…
FDA Forms Transparency Task Force
(FDA: Silver Spring, Maryland) -- The U.S. Food and Drug Administration (FDA) recently announced the formation of a task force to develop recommendations for enhancing the transparency of the agency’s operations and decision-making process. To support the efforts of the task force, the FDA…
QualiPedia: REACH--EU Hazardous Chemical Standard Reaches US
The European Union is working to make products safer for consumers and manufacturers alike. Its new regulations concerning chemicals used in product makeup, REACH, will extend across the pond to affect chemical standards in the United States. The new legislation will make everything from the…
Hospital Care Up 3%, Patient Safety Down 1%
Quality of hospital care in the United States is improving nearly 3 percent annually, remaining the highest rate of quality improvement among the major health care delivery settings, according to the National Healthcare Quality Report 2008 (NHQR), which was released in May by the Agency for…
FDA Awards $1 Million in Grants for Food and Feed Safety
(FDA: Silver Spring, Maryland) -- The U.S. Food and Drug Administration (FDA) recently enhanced its food and feed protection initiatives with the award of three one-year Food Safety and Security Monitoring grants totaling $1 million to the states of Arkansas, Nebraska, and Wisconsin. The funds…
Seventy Apply for 2009 Baldrige Award
Baldrige award medallion. (NIST: Gaithersburg, MD) -- Seventy organizations have taken the first step toward the 2009 Malcolm Baldrige National Quality Award, the nation’s highest recognition for innovation and performance excellence.…
Product Announcement: InfinityQS Announces Major Upgrade to ProFicient 4
(InfinityQS: Chantilly, Virginia) -- ProFicient 4 includes new enhancements and features to further help you improve quality and drive down costs. ProFicient 4 focuses on compliance reporting (useful for companies in regulated industries or companies who need to meet customer specifications), an…
Product Announcement: IBS Drives Quality Management Improvements with CompliantPro 7.2
(IBS: Lexington, Massachusetts) -- IBS, the global leader in enterprise quality and compliance solutions, today announced the latest release of CompliantPro, its web-based quality management software. CompliantPro 7.2 features increased platform support in product infrastructure as well as…
AHA Introduces 'Hospitals in Pursuit of Excellence'
(NAHQ e-news: Gleview, Illinois) -- Hospital leaders looking for field-tested practices, proven strategies, tools, and education to support ongoing efforts to improve the patient experience and outcomes in their hospitals have a new resource from the American Hospital Association (AHA). “…
FDA Requires Additional Labeling
(FDA: Silver Spring, Maryland) -- The Food and Drug Administration (FDA) recently issued a final rule that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks, such as internal bleeding and…
FDA Stresses Science-Based Compliance and Open Communication
(FDA: Salt Lake City)—Utah-based life science companies are being implored to utilize a scientific approach to regulatory compliance, and to keep the lines of communication open with the Food and Drug Administration. FDA district director Tom Warwick recently spoke with hundreds of life-science…
Updated FDA Process Validation Software
(Aegis Corp.: Lafayette, Colorado) -- Recent deployment of manufacturing process intelligence software “Discoverant,” from Aegis Analytical Corp., enables life science manufacturers to apply the updated principles and approaches for process validation outlined in the United States Food and Drug…
Cures and Quality at St. Jude’s Hospital
(InfinityQS International: Chantilly, Virginia) -- Saving the lives of children who have suffer from pediatric cancer and other catastrophic childhood diseases was the goal for InfinityQS when the company committed to donate $1 million to St. Jude Children’s Research Hospital. “We chose to…
Regulating Nanotechnology
(Project on Emerging Technologies and Food and Drug Law Institute: Washington) -- In 2007, the global market for goods incorporating nanotechnology totaled $147 billion. Lux Research projects that figure will grow to $3.1 trillion by 2015. Is the Food and Drug Administration (FDA) equipped to…
FDA Drug Law and Regulation Conference
(Food and Drug Law Institute: Washington) -- To help organizations stay in compliance with Food and Drug Administration (FDA) regulations, the Food and Drug Law Institute is hosting the “Introduction to Drug Law and Regulation: A Program on Understanding How the Government Regulates the Drug…
FDA Issues Guidances for Industry to Improve the Safety of Food, Feed, Drugs
(FDA: Rockville, Maryland) – In light of recent peanut butter and peanut products recalls, and to help ensure the safety of regulated products in the supply chain, the Food and Drug Administration (FDA) issued three guidances that include the following: Final guidance for industry on "…
Cardinal Health Pursues Lean Six Sigma Excellence Through Simulations
(Moresteam.com: Columbus, Ohio) -- Cardinal Health, a global manufacturer and distributor of health care supplies and technologies, uses innovative lean Six Sigma training methods to pursue their goal of total process and safety excellence. In a Feb. 19 web cast available to the public, Cardinal…
ISPE 2009 Tampa Conference
(ISPE: Tampa, Florida) – The International Society for Pharmaceutical Engineering, a global not-for-profit association of 25,000 pharmaceutical science and manufacturing professionals, will hold the 2009 Tampa Conference at the Grand Hyatt Tampa Bay in Tampa, Florida, March 2–5. Among the many…
Pilot Program to Improve Drug Safety
(FDA: Rockville, Maryland) -- In an effort to combat counterfeiting and contamination, the Food and Drug Administration (FDA) is launching a voluntary pilot program for drug makers to determine the practicality of developing a secure supply chain program. The goal of the program is to allow the…

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