The Biotechnology industry encompasses several types of companies, including those working in energy, agriculture, food science, and medicine, producing a variety of products. Biotechnology is involved in many leading edge life science technologies (from cancer drugs to DNA research), and must maintain regulatory compliance across multiple regulating bodies, including the FDA, the EPA and the USDA.
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The FDA has significantly increased oversight of blood centers and transfusion centers, and as a result, the blood industry must maintain compliance to applicable regulations (for example, 21 CFR parts 600, 606, 210-211 and 11). Having an an FDA Compliance Software system in place that can adapt to the changing regulatory environment, while being flexible enough to match evolving business processes is key in the blood banking industry.
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In the highly competitive Medical Device market, only the most innovative and cost effective products will survive. Success in this industry requires adherence to applicable FDA regulations (such as 21 CFR 820 and 21 CFR Part 11), and may also involve meeting ISO standard requirements (such as ISO 13485:2003). Rapid product development processes providing responsiveness to changing market demands are key to meeting the demands of this market.
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From discovery to clinical trials to patient delivery, introducing pharmaceuticals to market is often a long, involved process. In addition to the costs incurred in obtaining FDA approval, the expenditure to mass-produce products for the market can be substantial. Delays in delivering new medicine means lost revenue - to the tune of millions of dollars per day. This, coupled with the initial R&D investment (which can reach over $700 million), makes the business of introducing new medicines an expensive endeavor.
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When building and nurturing a food safety culture, food chain stakeholders are faced with challenges that include quality of products, continuous improvement, compliance with regulatory bodies, and safety and quality that spans the entire enterprise and supply chain. EtQ's Food Safety Management System (FSMS) helps ensure safety and quality are inherent throughout all processes, with capabilities for various levels of the food chain.
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A growing global economy and an increase in air traffic has made the world much smaller. As a result, the aerospace industry has experienced significant growth in the past few decades. As demand for air travel increases, so does the need for aerospace manufacturers, engineering firms, contractors, suppliers and more. The Aerospace industry is a highly competitive and technologically advanced industry, developing products that will help to take the global economy into the future.
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Companies in the automotive industry must adapt to changing customer demands and a global competitive market, but also must maintain a high level of safety and quality in their products. Increasing overall productivity and supplier quality, while maintaining a strong quality and safety system throughout the supply chain is a growing challenge for many automotive companies. Many companies are turning to Enterprise Quality Management systems to help achieve this task.
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EtQ has been at the forefront of providing Government agencies with a robust, flexible application to manage quality and safety. EtQ is recognized for helping one of the largest federal agencies in becoming the first of its kind to achieve ISO 9000 status. EtQ's Quality Management Software solutions help maintain quality while providing a flexible workflow platform to adapt to changing business processes, without programming.
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Companies in technology must maintain compliance to their Quality Management initiatives, such as ISO 9000 and ISO 14001. Having a system that is able to meet these requirements, while maintaining flexibility to adapt to rapidly changing business process is key. EtQ has developed a Quality Management Software solution for technology that allows for advanced workflow and business process management, and enterprise reporting capabilities to help companies stay ahead of the curve.
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Environmental Health and Safety standards like ISO 14001 and OHSAS 18001 are a very important part of the Chemical industry. Additionally, those in the Chemical industry must comply with regulations by the Environmental Protection Agency (EPA), and the Occupational Safety and Health Administration (OSHA). EtQ has developed an Environmental Health and Safety Software system to help maintain quality to these initiatives, while providing a flexible workflow platform to adapt to changing business processes, without programming.
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Compliance to environmental and safety standards such as ISO 14001 and OHSAS 18001 are most important to organizations looking to conform to Environmental Protection Agency (EPA) standards. EtQ has developed a Quality Management Software solution to help maintain quality to these initiatives, while providing a flexible workflow platform to adapt to changing business processes, without programming.
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This database is designed to manage the Deviation process. You will be able to identify deviations, develop a deviation plan with target completion dates, approve proposed deviations, and verify the completion of deviations that are in process.
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EtQ for Airlines is an integrated quality and compliance management system that has been pre-configured to specifically address the needs of the airline industry and maintain compliance to the standards set by the regulatory bodies of the aviation industry. EtQ's unique modular approach provides unparalleled flexibility and automation.
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