FDA Software Validation
The Pharmaceutical industry faces the task of meeting all FDA regulatory compliance requirements including 21 CFR part 211, part 210, part 820 and 21 CFR Part 11, and EC/EU/ISO regulatory compliance standards. From discovery to clinical trials to patient delivery, introducing quality assurance to pharmaceuticals and their markets is often a long, very disciplined process. In addition to the costs incurred in obtaining FDA approval, the expenditure to mass-produce consistent high quality 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 and years of effort), makes the business of introducing new medicines an expensive endeavor. FDA Regulatory Compliance is a key component of the product delivery process, and organizations must factor in their compliance initiatives as key to new product development process.
EtQ has developed an FDA Compliance Software Solution to help pharmaceutical companies maintain compliance with Current Good Manufacturing Practice (cGMP) and Electronic Signatures and Records (21 CFR Part 11) and EU Annex 11. The robust, workflow-based system supports the user transition from manual processes, and 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 as your process changes.
The Need for Pharmaceutical Regulatory Compliance
As part of the need for Pharmaceutical Regulatory Compliance, manufacturers must demonstrate not only an adherence to common Good Manufacturing Practices (cGMP) with respect to their processes and product manufacturing, they must also ensure that compliance is met within their supply-chain. EtQ has recognized the need for FDA Regulatory Compliance, and has developed a platform or a solution that provides organizations with the visibility to quality data and control of processes, mitigation of risks, and regulatory reporting and submission to provide a closed-loop pharmaceutical regulatory compliance solution.
Challenges Facing the Pharmaceutical Industry
As required by 21 CFR Part 11and EU Annex 11, a secure environment must be maintained, and the Pharmaceutical industry must be validated to maintain electronic signature and electronic record ES/ER integrity. As a result, validation services can double, or even triple the cost of a software system. EtQ recognizes the enormous task of FDA Compliance, and has services to help regulated companies quickly and confidently validate their EtQ environment. EtQ Validation Services provides you with a full list of options to assist in meeting the FDA's validation requirements.
To meet ISO compliance standards for the Pharmaceutical industry EtQ's FDA Compliance Software solution will ensure compliance with 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. The Pharmaceutical industry faces the task of meeting all regulatory requirements set forth by the FDA and other regulatory bodies. EtQ's Compliance Management Software solution is designed to meet regulations including 21 CFR Part 11, part 820, 210, 211; Quality System Regulation (QSR); EU/EC and more.
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 Compliance Management 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 be alerted to issues as they occur, automatically create reminders/escalations and ensures the suppliers provide the required responses to complete any of the items in the various manufacturing processes, providing a seamless Quality and FDA Compliance Management System, from start to finish. This improves the visibility and access throughout the entire global supply chain for critical stakeholders, especially external contract manufacturers and partners.
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.