How Does the FDA’s New Appraisal Approach Impact the Company’s Expectation in the Future?

Compliance managers using EQMS are understandably concerned about how legacy systems will stand up to the changes introduced by FDA’s Case for Quality.

At a recent webinar about the FDA initiative, an audience member asked, “For EQMS, how does this appraisal approach impact what companies can expect in the future?”

While not endorsing any brand name or system, an FDA representative replied, “From an FDA standpoint there are always benefits to adopting any type of automation. It does improve the capability to connect and get to some of that information faster in a more reliable and traceable format.”

Speed, reliability, connectivity, audit readiness — these are the hallmarks of EQMS. And they have been advanced to higher levels by today’s modern cloud-based systems. The EQMS that best deliver these hallmark qualities promise to play a critical role in helping companies adapt to FDA’s new approach to medical device regulation.

 


FDA envisions a future state in which the medical device industry achieves a mindset that blends
continuous improvement and product quality with improved patient safety as the ultimate outcome.

The FDA Case for Quality initiative uses the CMMI maturity model to measure a company’s capability to produce medical devices that are high quality and highly safe. Customized for the medical device industry, this model involves 11 appraisal metrics such as configuration management, requirements development and maintenance, and governance. To provide meaning, each of these measures is supported by large quantities of data pulled from across the device manufacturing organization.

Of the 11-appraisal metrics used in the FDA initiative, some are proving to be more valuable than others, participants say. Since the pilot program is only in its first year of implementation, these medical device quality metrics are likely to change over time as regulators and manufacturers work together to make this new approach more permanent.

A modern EQMS will become an asset in this evolving relationship between producers and regulators when it is built on reliable cloud- based architecture such as the Salesforce® platform, which offers the flexibility to integrate new applications and features in a rapid manner.

As background, Salesforce is the world’s most trusted cloud platform for business.
Initially designed to provide cloud-based applications for sales, service, marketing and more, the company has grown into a platform service for tailoring any application such as EQMS. Salesforce provides an advantage over cloud platforms from Amazon®, Microsoft®, Oracle® and others because it provides business application developers the configuration tools for a consistent approach to building the user interface, workflows, social collaboration, community portals, mobility, language, integration and reporting and analytics.

As this last point emphasizes, developing EQMS on the managed infrastructure of Salesforce.com rather than a proprietary cloud enables exclusive focus on applications, expanding the number and depth of medical device compliance solutions in response to fresh needs triggered by FDA’s changing approach. Salesforce keeps the underlying platform robust, secure, and innovative to support existing and new EQMS applications.

For their part, compliance managers using a cloud-based EQMS built on Salesforce.com can maintain the entire system using internal resources or 3rd party experts — meaning there’s no ongoing dependence on the EQMS vendor. This keeps expenses low compared with other EQMS solutions.

About ComplianceQuest

The vision at ComplianceQuest is to transform quality and compliance into a strategic advantage for our customers through experience, expertise and passion. ComplianceQuest is an innovative, 100% cloud based Enterprise Quality Management System solution company. We provide an enterprise grade solution that streamlines quality, compliance, content and collaboration management initiatives and strategies across diverse, globally based supply chain networks.

For more information, or to request a demo with a ComplianceQuest expert, contact ComplianceQuest today.

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