The Blood Services industry must maintain compliance with applicable regulations (for example, 21 CFR parts 606, and 1270-1271). The quality and safety of the blood supply is of the utmost importance. Between donor quality, suitable blood testing, and adhering to strict FDA and AABB standards, the Blood Services industry must maintain strong quality and FDA compliance systems.
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Having an FDA Compliance Software in place that can adapt to the changing regulatory environment, while being flexible enough to match evolving business processes is key in the Blood Services industry.
Challenges Facing the Blood Services Industry
As required by 21 CFR Part 11, a secure environment must be maintained, and the Blood Services 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 Blood Services 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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The Blood Services industry must ensure compliance with several agencies including the FDA, the Center for Biologics Evaluation and Research (CBER), and the AABB. This issue is a top pressure affecting the industry today. The FDA has recently enhanced FDA enforcement by putting stricter requirements in place, such as inspecting facilities every 2 years, and the ability to order recall or legal action. EtQ's FDA Compliance Software solution will ensure compliance with the FDA and other regulations such as 21 CFR Part 606 and 21 CFR Part 11 by ensuring that an organization identifies, accesses, and evaluates laws, regulations, and internal regulatory requirements.
As more Blood Services companies rely on Contract Manufacturers to bring their 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 Blood Services 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 and FDA Compliance Management System, from start to finish.
In the Blood Services industry, it is necessary to track blood components from initial donor collection to transfusion or disposal, as well as its current status—whether it has been processed, tested, and stored. Traceability is an essential tool in preventing post-transfusion infections. EtQ's Material Returns module aids in this process by ensuring that all returns are tracked and allows the organization to identify and track different types of returns, the reason for the return, as well as the material and quantity that needs to be returned.