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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Biotechnology regulatory requirements can fall under many categories, and are often regulated by more than one agency. Pharmaceutical-based Biotechnology industries must maintain compliance with the applicable FDA regulations, and quality management or environmental based biotechs may also choose to adopt ISO 9000 and ISO 14001 systems. Having an FDA Compliance Software system to maintain compliance with the variety of regulatory requirements, and adapting to business processes is very important to biotechnology.
Challenges Facing the Biotechnology Industry
Electronic Submissions to the FDA eMDR
The FDA receives upwards of 400,000 medical device reports annually. In order to give each of these events the individual attention necessary to mitigate risk, the FDA must be properly informed by an organization of all reportable adverse events. Electronic reporting is key to ensuring proper collaboration. EtQ has the ability to submit electronic medical device reports (eMDRs) 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. EtQ 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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As required by 21 CFR Part 11, a secure environment must be maintained, and the
Biotechnology 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 Biotechnology 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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As more companies rely on Contract Manufacturers to bring their biotechnology 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 Biotechnology 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.
Manufacturers in the Biotechnology industry face the task of meeting all regulatory requirements set forth by the FDA and other regulatory bodies, including the National Institutes of Health (NIH), and the Occupational Safety and Hazard Administration (OSHA). This issue is a top pressure affecting the industry today. EtQ's FDA Compliance Software solution will ensure compliance with regulations such as ISO 9000 and 21 CFR Part 11 by ensuring that an organization identifies, accesses, and evaluates laws, regulations, and internal regulatory requirements.