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Automotive Industry and Food, Safety, and Drug Regulations
Enterprise application providers wanting to address the distinct regulatory requirements of the automotive, food, safety, and life sciences industries need to

drug approval  products. For example, approved drug products that have been developed and produced according to GMPs are expected to be safe, properly identified, of the correct strength or potency, pure, and of high quality. At a high level, GMPs address the proper design, maintenance, and cleaning of equipment and facilities; the development and approval of standard operating procedures (SOPs); the need for an independent quality unit (such as quality control or quality assurance); and the qualifications and training Read More
Web Content Management (WCM)
Web content management (WCM) systems manage content creation, review, and approval processes for web site content. This may include public Web sites (Internet) or private web sites (intranet or ext...
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Documents related to » drug approval


Expandable Case Study: Thermage, Inc.
After receiving US Food and Drug Administration (FDA) approval for its ground-breaking product, medical technology startup Thermage, Inc., was looking to

drug approval  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. Read More
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

drug approval  (ERP) (Wikipedia) Food and Drug Administration (FDA) (Wikipedia) Medical Device Manufacturers Can Leverage ERP/CRM Software to Facilitate FDA Compliance FDA Compliance is also known as : FDA Approval , FDA Approval Guidelines , FDA Compliance , FDA Compliance Consultants , FDA Compliance Consulting , FDA Compliance Guidance , FDA Compliance Guide , FDA Compliance Guidelines , FDA Compliance Manual , FDA Compliance Officer , FDA Compliance Policy , FDA Compliance Policy Guide , FDA Compliance Program , Read More
A Portrait of the Enterprise Software User in the Pharmaceutical Industry
The pharmaceutical industry faces strict regulatory requirements in the approval of drugs for treatment of diseases. Software can help pharma successfully

drug approval  requirements for a new drug approval in a particular country. To be competitive, pharmaceutical companies need to be efficient and quick to bring drugs to market, while ensuring a high level of drug efficacy and safety. Successful pharmaceutical companies have been able to achieve this all the while facing many challenges, including a shift from developed markets to emerging markets, lengthy and costly drug approval processes, increased availability of generic options, and adoption of breakthrough Read More
Orchid Orthopedic Solutions Selects CEBOS QMS
Orchid Orthopedic Solutions recently selected CEBOS MQ1 Elements Life Sciences solution to automate its quality management system (QMS) and ensure compliance

drug approval  for Standardization (ISO), Federal Drug Administration (FDA), good manufacturing practices (GMP), and more. Functionality includes configurable forms and workflows, electronic signatures, audit trails, and validation scripts. The software thus significantly reduces the time required to complete and maintain regulatory compliance while providing staff with visibility to business processes, tasks, and timing.   CEBOS, a division of QAD Inc. , provides a suite of EQMS and environmental, health, and safety Read More
E-Procurement Is Not Electronic Purchasing - Part II
Three minutes of labor from purchase requisition to invoice payment; fully executed due diligence; commitment authorization and no delays. That is the promise

drug approval  Procurement Is Not Electronic Purchasing - Part II E-Procurement Is Not Electronic Purchasing - Part I I J. Dowling, C. Sabean, and D. Geller - November 14, 2000 Introduction This second part of an extended note on e-procurement examines the necessary steps after a business decision to go with e-procurement has been made based on the information and criteria covered in Part I. E-procurement is an integrated system of services and technologies that provides a seamless bridge between buying and selling Read More
Case Study: Securing Servers, Oracle Databases, and Embedded Systems in a Health Care Environment
A non-profit hospital needed to protect its critical clinical systems without either interrupting system availability or overloading the small IT security team.

drug approval  due to Food and Drug Administration (FDA) regulations. Find out how a server security solution helped the hospital address these challenges. Read More
RFID in Healthcare--A Whole Industry of Value
This article talks about recent and expected FDA regulations and how RFID can help meet those requirements while improving supply chain performance.

drug approval  2004—the U.S. Food and Drug Administration released its final report today on ways to reduce the counterfeiting of prescription drugs. The report's recommendations include the use of RFID technology to create a pedigree —a secure record documenting that the drug was manufactured and distributed under safe and secure conditions. FDA said: The adoption and common use of reliable track and trace technology would help secure the integrity of the drug supply chain by providing an accurate drug Read More
Are Spend Management (or SRM) Apps Suited for the Mid-market? - Part 1
My previous blog entry about procurement commandments in a down economy also made me think about whether there are different priorities for the chief

drug approval  Spend Management (or SRM) Apps Suited for the Mid-market? - Part 1 My previous blog entry about procurement commandments in a down economy also made me think about whether there are different priorities for the chief procurement officer (CPO) during prosperous economic times. Or, how different are (or should be) the CPO’s strategies in good versus bad times? Well, the CPO’s fundamental objectives do not change: procure the physical goods and services needed by the company at the best possible mix Read More
What Could Process Manufacturers Do Better in PLM?
Part 1 of my recent blog series, Filling the Holes and Breaking Down Artificial Walls in a Process PLM Solution Set, established that the product lifecycle

drug approval  of US Food and Drug Administration (FDA) recalls is inaccurate label content. The current artwork process can be best described as changing tires on a moving car. Since design, proofs, and printing are outsourced, the lead times and chances of introducing errors are increased. With each formula change, claims or product attribute content are likely to change as well. With each upcoming promotion or season, digital assets or claims may change. As the owner of the artwork, companies can minimize the cost Read More
It’s About Process (or the Ability to be Responsive) -- Part IV
Part III of this blog series introduced Webcom ResponsAbility, the on-demand workflow automation and business process management (BPM) solution. Anyone

drug approval  About Process (or the Ability to be Responsive) -- Part IV Part III of this blog series introduced Webcom ResponsAbility , the on-demand workflow automation and business process management (BPM) solution. Anyone interested can take the product for a free trial test drive here . Other Real Life ResponsAbility Use Examples In addition to the examples described in Part III , another example of the ResponsAbility software in use can be found in Grayhill, Inc. an electronics manufacturer from Lagrange, Read More
Remedy Welcomes You To Your New Office. Now Get To Work!
At Remedy there is a 5 working day service level agreement for getting new employees up and running. If an employee accepts a job at least five days before the

drug approval  Welcomes You To Your New Office. Now Get To Work! Product Background Bob Keane, Remedy Corporation's Senior Product Manager for the Remedy SetUp@Work product started work only four days after he was hired. Although his own desktop machine hadn't been delivered yet, he was set up with a loaner, and all permissions and links were in place so that he could start to work. In addition, he could easily check the status of his PC, desk blotter, trash basket, and other yet-to-be-delivered items from a Read More

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