Documents » flagging allergy and drug interactions.
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: Deploying voice self-service (VSS) is undeniably attractive to enterprises because it improves the speed, consistency, and convenience of information sent to customers, and decreases costs. Knowledge bases play a key role in helping enterprises achieve greater return on investment because they link web- and speech-based self-services together. In particular the emergence of VoiceXML has truly shifted speech and IVR platform hosting options.
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: Enterprise applications have long been providing the means for businesses to collect required data and deliver it to the right people. Now that sales and marketing professionals are empowered with the right tools to better serve their customers and gather insights on all customers' interactions, the question to ask is what's next? We see the answer in a tight integration between Enterprise applications and Analytics.
Abstract: Once we cross the border of the enterprise, traditional enterprise-centric systems fail to provide visibility or a way to understand and act, all in sync with our supply chain partners. This is why the delivery architecture of an application is critical, especially for addressing multi-enterprise interactions.
Abstract: When important information is withheld, it leads to enormous inefficiencies or even disasters in the supply chain. Trust is needed to streamline decision making and interactions in the supply chain. But, in spite of what
Abstract: e-Commerce initiatives that are launched without a clear vision of how customers are engaged and what they experience carry significant risk of failure. Of equal importance is a clear understanding of the degree to which web-based customer interactions are integrated across the organization.
Abstract: Remedy announced its acquisition of Axtive Software Corporation, a provider of relationship marketing software that supports personalized interactions between surfers and websites.
Abstract: While PeopleSoft has added yet another bit of weight to its applications portfolio with the acquisition of Annuncio, potentially earning thereby the ability to manage marketing campaigns and track individual customer's interactions across online and off-line channels, one is to wait and see how quickly and easily the company will assimilate a number of smaller products it has recently bought.