Documents » managing drug formulary.
Abstract: 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?
PubDate: 7/11/2008
Abstract: It’s old, it’s new, and it’s the future. Pedigree tracking regulations were originally passed into law through the Prescription Drug Marketing Act of 1987 (PDMA). After two decades of postponing enforcement, the US Food and Drug Administration (FDA) has lifted its final stay. Pharmaceutical companies are expected to be in compliance with 21 CFR Part 203 by the year 2011. Do you have what it takes for compliance?
Abstract: Enterprise application providers wanting to address the distinct regulatory requirements of the automotive, food, safety, and life sciences industries need to offer enterprises industry-oriented enterprise resource planning systems that are sound and compliance-ready.
Abstract: 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.
Abstract: A non-profit hospital needed to protect its critical clinical systems without either interrupting system availability or overloading the small IT security team. The hospital had to overcome several vulnerabilities, such as the fact that some clinical systems could not be patched due to Food and Drug Administration (FDA) regulations. Find out how a server security solution helped the hospital address these challenges.
Abstract: Counterfeit medicine is a major threat to the pharmaceutical industry. Seven percent of the medicine worldwide is counterfeit; however, advances in packaging and labeling technologies are coming to the industry’s aid. Pharmaceutical companies are using pilot projects to help labeling implementations throughout the supply chain to increase the availability of safe, licensed medicine and thwart the underground drug market.
Abstract: After receiving US Food and Drug Administration (FDA) approval for its ground-breaking product, medical technology startup Thermage, Inc., was looking to install manufacturing software that would fit a limited budget and meet its long-term needs. By going with Expandable ERP, Thermage was able to implement a full-featured manufacturing system that helped it ramp up production and maintain FDA compliance.
Abstract: In less than six months, RxAmerica was able to respond to unprecedented call volume—primarily from seniors seeking information on the US Medicare prescription drug program—by increasing their service representative population by more than 500 percent, and by opening 6 new call centers. The cornerstone of their solution: a hosted call routing platform.
Abstract: 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.
Abstract: Software validation is required by any company covered by the US Food, Drug and Cosmetic Act and 21 CFR Parts 210 & 211. Many small to mid-sized companies see this as an overwhelming task, but when approached in a logical manner, it does not have to be. This white paper will guide you through ten steps in making your validation run more smoothly and successfully.
Abstract: LiDestri Foods, a food and beverage manufacturer, needed an integrated process manufacturing solution that would help it conform to current good manufacturing practices (cGMP) requirements. ProcessPro had the controls and tools necessary to manage the multiple-level formulas typical of industries regulated by the Food and Drug Administration.
Abstract: To successfully meet compliance demands, pharmaceutical manufacturers must develop, implement, and track the effectiveness of a company-wide compliance strategy. Key to that strategy is to adopt industry-specific enterprise software with functionality that supports Federal Drug Administration (FDA) requirements. Learn more about the criteria and recommendations you need to achieve compliance in the pharmaceutical industry.
Abstract: In hard economic times, IT organizations can maintain operational excellence and sustain service quality while still reducing costs. Achieving this objective involves at least three aspects of application management: managing change, managing technical performance, and managing user performance. Learn more about managing the change process in your PeopleSoft environment, and the value of an integrated change solution.
Abstract: In the post Y2K era, many companies have turned to the CFO to oversee the IT function with the CIO or head of IT reporting to the CFO. IT may look organizationally like accounting, but the issues a CFO will face in managing IT will be complex and involve an organizational approach that is focused on the unique aspects of managing IT.
Abstract: As supply chains continue to grow in size and complexity, companies are focusing more of their energies on managing supply chain risk. While the topic is gaining prominence in boardrooms, many companies do not yet fully comprehend the risks they face. But understanding risk is the first step to managing it—and using the right IT tools can help. Learn what steps you can take to better address your supply chain risks.
Abstract: Customizing third-party “vendor” source code is becoming increasingly common. But managing the incorporation of vendor application releases alongside customizations requires an additional layer of software configuration management (SCM) to integrate subsequent vendor releases. Traditional branch-based SCM tools require an unnecessarily complex branch-and-merge process. However, there is a more intuitive and efficient parallel development model for managing customizations to vendor code.
Abstract: Though many academic methods exist, few actually reach the audience they need to reach because of the barrier between academic and business languages, as well as the ability to produce workable and usable tools. This article summarizes what I believe are the methodologies most used in Business, and some of the tools that are commercially available.
Abstract: Poor measurement methods can take off millions or more from bottom lines, and contribute at least in part to project failures, corporate inefficiencies and poor technology selections. Industry wide, they have contributed to tens of billions of dollars of unnecessary costs. How do you avoid these expensive mistakes?
Abstract: This is a reprint of the summary chapter from the book Managing Your Supply Chain Using Microsoft Navision by Dr. Scott Hamilton.