Quintiq The Quintiq Planning & Scheduling software is unique in the sense that it comprises standard software creating an exact fit to the customer’s needs. The Quintiq software is applicable for strategic, tactical and...
Amadeus International inc. Amadeus, a division of DECIMAL is a pioneer and leading provider of Enterprise Quality and Compliance Management software solutions. For over 14 years, customers in the Life Sciences, Manufacturing, Financial Services...
Oracle Reflecting Oracle's ongoing industry commitment, Oracle Health Sciences is uniquely positioned with the products, vision, resources, and industry expertise to fulfill existing and emerging needs in an environment...
This paper documents a solution provided by DMC to one of its customers in the form of a vision inspection and data acquisition system. DMC is an engineering consulting company that provides custom software solutions for its customers. For this project the customer is a company that operates chemical plating processes for metal products. In this solution, a “smart” digital camera is set up and ...
The FDA rule relating to the use of Electronic Records and Electronic Signatures (21 CFR Part 11) is one of the most significant pieces of new legislation to affect the pharmaceutical manufacturing industry in recent times.
With ever greater use of information technology and computer systems at all stages of manufacture, more and more of the operating processes are being automated. As a result, ...
A Paradigm Shift in the Pharmaceutical Sales Model
By: Richard W. Johnston Vice President and Founder, AdvantageMS
Property of Advantage Management Solutions, Inc Confidential
A Paradigm Shift in the Pharmaceutical Sales Model
Over the last twenty years the pharmaceutical industry has experienced extraordinary sales growth as a result of new product introductions, market expansions and the ...
Pharmaceutical and biotech companies of all sizes are increasingly turning to third parties to execute some or all of their clinical supply activities. There is a need for these companies to control and track these activities in their information systems.
This article addresses the various methods in which the activities of third-party supply contractors and IVRS (Interactive Voice Response ...
HighPoint Solutions leads the strategy and integration of a new contracting and pricing system for pharmaceutical manufacturers. Learn how your organization can leverage HighPoint Solutions’ experience and work with the pharmaceutical division to enable clients to jumpstart implementation.
The purpose of this white paper is to document and summarize the current status of the regulatory requirements set forth by different agencies like FDA (in US), ICH (in Europe), and that of Japan and China. In the first section of the paper we will provide the background information on the role of FDA, the regulatory agency in the USA, and the current state of cGMP “risk based approach” enforced ...
In an era characterized by the need to continuously evaluate and bolster R&D pipelines, the increasing complexity and overall cost to develop and approve drug products, the trend toward genericization, and mounting pressures to both decrease prices and maximize profitability, the pharmaceutical industry has sought competitive advantage in lower cost manufacturing jurisdictions.
The ...
Pharmaceutical manufacturing executives today are all too familiar with industry regulations such as Title 21 CFR Part 11 and current good manufacturing practices (cGMPs). However, many drug companies still struggle to comply with these and other U.S. Food and Drug Administration (FDA) requirements.
In 2008 alone, the FDA issued 43 warning letters to pharmaceutical companies for regulatory ...
It is a universal truth that research, development manufacture and formulation of potent active pharmaceutical ingredients (APIs) and products requires both “hardware” ( facilities, equipment and engineering controls) and “software” (programs, practices and procedures) to adequately protect personnel and the environment. When employing third party contracting organizations, there is a need to ...
In the regulated life sciences industry failure to meet expectations can not only bring down reprimands from senior management, who themselves are often complicit in the failure, but also can evoke the “attention” of the FDA or other international regulatory agencies. Fortunately there are 10 simple tips to follow for a successful CMMS or EAM system implementation.
Watch this video to learn more about the Hyaluron Contract Manufacturing syringe filling system.
Inova H3-5V
1 mL long to 20 mL
up to 100,000 units per ...
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