It is impossible for FDA-regulated manufacturers to conduct business without paying close attention to regulatory compliance.
FDA regulations can introduce increasing complexity into internal business processes, delaying the pace of innovation and new product introduction. And complying with regulations is expensive, with the cost of compliance now estimated at two percent of revenues. The expense, however, pales in comparison to the potential costs and risks associated with non-compliance.
Regulatory issues confronting regulated manufacturers can be expressed in the form of the following questions:
Investing in a scalable, enterprise compliance solution can have significant top-line and bottom-line benefits that extend well beyond simply achieving compliance.
Quality management presents unique challenges for regulated manufacturers because, in addition to the many quality challenges that face all manufacturers, regulated manufacturers also have to meet strict regulatory requirements in their quality systems. This burden can add significant overhead to quality systems, making it even more difficult for medical device manufacturers to remain competitive.
In an environment tightly controlled by regulatory requirements, regulated manufacturers must be able to demonstrate that disparate quality management systems and procedures are executed consistently across the enterprise. To comply, many companies try to force these disconnected systems to integrate but this creates additional challenges in managing separate systems that must communicate with one another.
Quality systems (i.e., document control, deviations control, non-conformance, equipment calibration, equipment maintenance orders, audit, CAPA, change control, training and the overall functions and philosophies that control product outputs) are often controlled manually or with a hybrid system.
For example, quality system documentation, though it is the lifeblood of a quality system and is required by most regulatory organizations (FDA, ISO, CLIA, etc.), is often routed, viewed, approved and archived using paper-based or hybrid systems.
These manual or hybrid processes greatly slow the pace of a product to market and literally cost many life science companies hundreds of thousands or even millions of dollars for every day a product is delayed. In addition, employees who undertake these manual processes are also being paid for the performance of potentially superfluous tasks.
A quality system that provides analytics/reporting features makes deviations and non-conformance data far easier to analyze and with streamlined connections, deviations and non-conformance data can be configured to trigger results from CAPA, change control or training solutions.
Furthermore, quality system solutions that make communication simpler, such as web-based solutions that allow for collaboration, are especially valuable as are solutions that provide audit trails for documentation and all quality system related processes.
A QMS also provides more strategic benefits to any given company. These benefits include:
The call is out for pharmaceutical, medical device and other regulated companies that need to meet FDA regulations and ISO requirements to consider quality system technology which can help them meet new regulatory requirements and business initiatives that allow manufacturers to expand into new markets more quickly, creating competitive advantage and differentiation.
Many firms are taking a more strategic view of their QMS investments. These views extend beyond the concept of compliance and are characterized by the following:
The new system will provide a mechanism to achieve key quality objectives such as issue tracking, developing and implementing corrective actions and reporting on the key process improvement metrics.
While the action of meeting these requirements enables an organization to standardize and automate its approach to quality improvement, it does not bring to light the key quality-related issues that senior management worries about.
Key Issues for Senior Management:
A justification for a QMS must address how the system will address three key issues: bottom-up operational management, top-down risk and cost management and financial returns on investment.
A well-framed 'request for budget' that addresses bottom-up operational needs and top-down management requirements, along with well-quantified financial justifications, will go a long way in satisfying all relevant stakeholders to approve the funding for a Quality Management System.
At a tactical level, the following is a list of objectives that a QMS request-for-budget document should clearly address:
The answer to that question is: Your Bottom Line and also can be found in the bottom line of your company's performance statement.
Companies whose products are regulated by the FDA, especially pharmaceutical and medical device companies, stand to increase their workable return on investment by millions of dollars with quality system technology that accelerates innovation and streamlines compliance.
In an age when companies stand to make millions of dollars each year, making products that are safe and effective is a matter of compliance and quality driven processes that are now hard-wired within regulated environments.
Jon Nugent is currently the Managing Director of Client Services at Business Intelligence Solutions, a firm dedicated to providing regulatory compliance solutions and information technology services to FDA regulated industries.
Jon is an experienced regulatory and compliance executive who works with FDA-regulated companies. In recent years, Jon's role at Business Intelligence Solutions has had him focusing on regulatory compliance solutions and professional services that enable companies to adapt to new regulatory requirements and business initiatives that allow them to expand into new markets, streamline compliance and accelerate innovation.
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