Pharmaceuticals
The Pharmaceutical industry faces the task of meeting all FDA regulatory requirements including ISO 13485 and 21 CFR Part 11, and other ISO compliance standards. From discovery to clinical trials to patient delivery, introducing quality assurance to pharmaceuticals and their markets 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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Staying on top of regulatory requirements while producing safe and effective products is vital. More and more companies are turning to highly configurable, flexible quality assurance software systems to adapt to the ever-changing regulatory landscape. EtQ has developed an FDA Compliance Software Solution to help pharmaceutical companies maintain compliance to Current Good Manufacturing Practice (cGMP) and Electronic Signatures and Records (21 CFR Part 11). The robust, workflow-based system allows for the automation of business processes, without programming or custom development. This ensures a system that will not only meet/exceed the requirements of today's regulations, but also be flexible enough to meet future needs.
Challenges Facing the Pharmaceutical Industry
Validation
As required by 21 CFR Part 11, a secure environment must be maintained, and the Pharmaceutical industry must be validated to maintain electronic signature integrity. As a result, validation services can double, or even triple the cost of a software system. EtQ's FDA Compliance Software is designed specifically for the Pharmaceutical industry, and our staff has developed the test scripts necessary to ease system validation. Because EtQ's FDA Compliance Software is usable right out of the box, and configurations are executed at the server level, the need for extensive validation across the enterprise is less than comparative Quality Management and FDA Compliance Management Software systems in the market.
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Regulatory Compliance
To meet ISO compliance standards for the Pharmaceutical industry EtQ's FDA Compliance Software solution will ensure compliance to regulations such as ISO 13485 and 21 CFR Part 11 by ensuring that an organization identifies, accesses, and evaluates laws, regulations, and internal regulatory requirements. EtQ's quality assurance also has the ability to electronically submit reports of adverse events directly through the FDA's automated gateway. This process expedites the process of submitting reports by eliminating the need for faxing, mail, and other manual processes. Reports are submitted electronically and receipt is acknowledged within 6-12 minutes of submission. eMDR is tied directly into EtQ's Complaint Handling Software and CAPA Software workflows and enables two-way integration with the FDA.
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Contract Manufacturing
As more companies rely on Contract Manufacturers to bring their pharmaceutical products to market, it is important that the systems implemented allow for increased visibility downstream. EtQ's FDA Compliance Software provides integration at multiple levels of the process, allowing contract manufacturers to take part in the overall Pharmaceutical industry, without direct access to the main system. This allows the Contract Manufacturers to fill in their pieces of the process, and provide a seamless Quality Management System, from start to finish.
Demand for Innovation
The Pharmaceuticals industry must offer the most innovative products in order to stay ahead of the competition and meet customer requirements. This aspect of the industry makes change necessary. Using EtQ's Change Management function, quality is linked throughout the product lifecycle as opposed to just the end product and is tracked at design, production, suppliers, and post-production - providing a real-time quality benchmark at every step of the process. Modules such as Risk Assessment, Supplier Rating, and Project Control integrate with Change Management to ensure a best-in-class quality solution.
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Recall Management
The FDA provides a holistic environment for effectively tracking Recall Management and automating the recall process. Automated Recall Management guides an organization seamlessly through each step of the recal - from submitting information to the FDA to evaluating the recall - while providing integration with GMP modules such as Change Management, to further enhance the process.
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