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- FDA Regulations and Auditing Practices for Software Suppliers at a Pharmaceutical Manufacturer
- This article investigates the software-supplier auditing practices in the pharmaceutical manufacturing environment by reviewing 17 quality audit reports performed between 1992 and 2003 by a major international pharmaceutical company. From this analysis thThis article investigates the software-supplier auditing practices in the pharmaceutical manufacturing environment by reviewing 17 quality audit reports...
- Research articles 2004-09-01
- BASF automates bulk pharmaceuticals production: beginning with a SCADA system to improve purine production at its Minden, Germany, pharmaceuticals plant, BASF has expanded use of batch software to respond to daily market demands and unexpected plant-floor
- Demand for bulk pharmaceutical products, such as caffeine, theophylline, ephedrine, and pseudoephedrine, has grown so consistently that BASF's Minden, Germany, pharmaceutical plant existed in a near-continual state of expansion to meet production r Demand for bulk pharmaceutical products, such as caffeine, theophylline, ephedrine,...
- Research articles 2006-02-01
- SAS Supports Launch of Inaugural Pharmaceutical Users Software Exchange in Heidelberg; Knowledge Exchange Event for SAS® Professionals in the Pharmaceutical Industry
- HEIDELBERG, Germany -- SAS, the leader in business intelligence, will host the first-ever Pharmaceutical Users Software Exchange PhUSE Oct. 10-12, in the historic city of Heidelberg, Germany, at the Kongresshaus Stadthalle Heidelberg, opposite SAS EMEA Headquarters. The inaugural PhUSE event is being organized by a committee of pharmaceutical industry leaders...
- Research articles 2005-08-30
- India's Top 50 Companies By Market Capitalisation - Brief Article
- RANK NAME INDUSTRY 1 ...
- Research articles 2000-09-01
- Datasweep Delivers Unified Software Platform for Pharmaceutical Manufacturers; Responds to New FDA Guidelines for ''cGMPs for the 21st Century''
- SAN JOSE, Calif. -- Datasweep, Inc. today announced comprehensive and unified support for the FDA's emerging Current Good Manufacturing Practices cGMPs for pharmaceutical manufacturers. Pharmaceutical companies facing stringent regulatory and product supply challenges will benefit from the software's ability to span multiple manufacturing sites, tightly integrate quality management procedures with...
- Research articles 2004-12-23
- Dendrite Signs Comprehensive Software Services Agreement with Esprit Pharma; Esprit Looks to Dendrite's WebForce™ Express and Full Suite of Sales Support Services to Help Foster Growth and Market Expansion
- BEDMINSTER, N.J. -- Dendrite International, Inc. (NASDAQ: DRTE) a leading provider of sales, marketing, clinical and compliance solutions for the life science and pharmaceutical industries, today announced that Esprit Pharma, Inc. has signed a comprehensive, three-year several million dollar software and services agreement with Dendrite. This customer win was previously...
- Research articles 2005-08-23
- 21 CFR Part 11 and systems assessment: key to complying with the FDA's electronic record-keeping regulation and reaping the associated benefits is understanding regulation requirements and the software to support compliant operations.(INSIDE PHARMA)
- By establishing the criteria under which electronic records and electronic signatures are considered equivalent to paper records and handwritten signatures executed on paper, 21 CFR Part 11 has given the pharmaceutical industry a universally accept By establishing the criteria under which electronic records and...
- Research articles 2005-04-01
- Validation services software: for pharmaceutical and other FDA-regulated manufacturers. (Systems Integration & Solutions).
- R300 version of Enterprise Buildings Integrator software is an enhanced project delivery and validation framework service to help FDA-regulated pharmaceutical, nutraceutical, biotechnology and medical device manufacturers meet the challenges of reg R300 version of Enterprise Buildings Integrator software is an enhanced project delivery...
- Research articles 2003-06-01
- Datatrak trekking to D.C. to offer software to NIH.(Technology)(president and CEO of Datatrak International Inc.)
- Byline: JEFF STACKLIN Jeffrey Green is going to Washington, D.C., to build his business. Dr. Green is president and CEO of Datatrak International Inc., a software company in Mayfield Heights that helps pharmaceutical companies collect and mainta Byline: JEFF STACKLIN ...
- Research articles 2003-11-17
- Datatrak collecting more fans; Wall St. taking notice of software firm's growth.(software developer aids pharmaceutical companies)
- Byline: JEFF STACKLIN Datatrak International Inc., a software developer in Mayfield Heights that enables pharmaceutical companies to collect research data via the Internet, is beginning to make some noise around the world - and on Wall Street. Byline: JEFF...
- Research articles 2003-08-18
- A Pharmaceutical Industry Wish List And Reality Check
- With the strong winds of competition beating down on the pharmaceutical industry, the race is on to build stronger relations, to claim a better share of the market, to cut costs, and become more efficient. Amidst all the activity, somewhere is the relationship between the patient, doctor, sales force, and...
- White papers 2003-04-08
- Healthcare, Pharmaceutical And Biotech Resilient Amid Job Market Woes
- On the one hand where most industries were badly hit by the aftermath of September 11 incidents, there were few exceptions also. The industries such as healthcare, pharmaceutical, and biotech remained flexible despite job market's affliction. The paper elaborates on how the exceptional industries remained untouched by the suffering economy....
- White papers 2003-01-01
- Item-Level Visibility in the Pharmaceutical Supply Chain: A Comparison of HF and UHF RFID Technologies
- This paper sheds light on the myths and confusion surrounding RFID and addresses the choice of HF versus UHF technology for item-level pedigree pharmaceutical tracking. It also provides an overview of some of the commercial pharmaceutical and healthcare field trials and implementations. The numbers are astounding and the stakes couldn't...
- White papers 2004-07-01
- West Pharmaceutical Services
- West Pharmaceutical Services, Inc. (NYSE:WST) is a global drug delivery technology company that applies proprietary materials science, formulation research and manufacturing innovation to advance the quality, therapeutic value, development speed and rapid market availability of pharmaceuticals, biologics, vaccines and consumer healthcare products. When an explosion ripped through its Kinston, N.C.,...
- Case studies
- Pharmaceuticals/Health Care: Safety and Security in the Spotlight
- This article discusses about the safety and security in healthcare and pharmaceutical sector. The U.S. business community?and society in general?have become markedly more security conscious following the havoc of 9/11, and this new awareness has spotlighted the vulnerability of food and drug supply chains. Regulatory watchdogs of the already highly...
- White papers 2004-06-01
- Access to Medicines and Pharmaceutical Patents
- All countries agreed, in principle that, in circumstances of national health emergencies, developed countries should be allowed to grant compulsory licenses to manufacture generic pharmaceuticals for export to countries, which lack pharmaceutical manufacturing capacity. However, there is no agreement on the appropriate definition of health emergency and without this the...
- White papers
- Caught in the Cross Chairs
- The pharmaceutical industry stands in the crosshairs of federal and state law enforcement agencies. It is not being targeted by FDA for regulatory violations, as one would expect, but by many other government agencies. Some of the issues in question are the way pharma companies calculate and report product prices...
- White papers 2002-04-15
- Pharma 2005 Marketing to the Individual
- The world in which all live is changing, and the PricewaterhouseCoopers Global Pharmaceutical Practice has taken on the challenge of exploring the future and its implications for today's pharmaceutical companies. From the forces converging on the individual to the acceleration of change due to the e-environment, we have explored multiple...
- White papers 2001-05-15
- Process Validation: Moist Heat Sterilization for Pharmaceuticals
- This document is intended to provide manufacturers of pharmaceutical dosage forms with guidance to establish the scientific effectiveness of moist heat sterilization processes, as required in Sections C.02.004, C.02.005, C.02.007, C.02.011 and C.02.029 of the Food and Drug Regulations. This guideline is applicable to moist heat sterilization processes only. While...
- White papers 2001-05-01
- The Human and Economic Value of Pharmaceutical Innovation and Opportunities for the NHS
- Innovation is vital in the health care system. Innovation can be about improving compliance with existing treatment regimes, bringing new ways of treating patients, providing their treatment more cost effectively, or expanding the boundaries of what can be treated. Innovation can come in many forms new medicines, different devices, improved...
- White papers 2004-05-07
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