The 5 Maturity Models Used in FDA’s Case for Quality Pilot Program

In a future shaped by data and connectivity, modern EQMS stands out. While not required to participate in FDA’s Case for Quality pilot, EQMS makes collecting, processing, and analyzing the required data faster and more reliable compared with disparate or legacy QMS systems, spreadsheets, or paper documentation.

The value of automation within a centralized EQMS can only increase as the volume and types of medical device manufacturing data continue to expand. As the Case for Quality process spreads widely across the medical device industry, there will be more pressure on compliance managers to pull key data from records, slice it and dice it to provide meaningful analysis, and report it in a comprehensive form to the experts who conduct facility appraisals.

Of course, data volumes have grown exponentially in recent years and will continue to do so, but so have the innovative ways to utilize data. Artificial intelligence, the internet of things, smart machines, and other innovations are creating huge leaps of progress — all enabled by improvements in data management and analytics. Legacy EQMS systems are not architected to work in this new data ecosystem.

By contrast, the modern EQMS built on Salesforce provides a 100% cloud-based platform for connecting data from multiple sources, creating interactive views of that data, and sharing those views in apps. Compared with legacy systems, a 100% cloud-based QMS provides more intelligent ways to distribute insight to business users so they can understand and act on changing compliance information. This offers distinct advantages to companies as they move toward the new FDA regulatory model.

In a future shaped by data, where FDA’s regulatory paradigm for medical devices has shifted from an audit mindset to an appraisal model, modern EQMS systems are best positioned to deliver value for medical device manufacturers. They perform at scale and scale up to help medical device compliance managers stay on top of this data revolution now and in the future.

Modern EQMS supports a new regulatory approach for device firms of all sizes. Not surprisingly, FDA launched its Case for Quality initiative in partnership with large, prominent medical device companies. Yet in the coming years the new approach is expected to be applied to all organizations regardless of size. With this future state in mind, it’s helpful to note that a modern EQMS built on Salesforce can scale from 5 to 10,000+ users easily and with no further intervention from medical device compliance managers.

Not only does a modern cloud-based EQMS support organizations as they scale up in number of users, it also helps them move up the maturity scale. As mentioned, the FDA Case for Quality initiative detailed here utilizes the Capability Maturity Model Integration during medical device facility appraisals.

Below are the five maturity levels used in the program, starting with the most mature.

Moving up this maturity scale can be accelerated by a modern 100% cloud-based EQMS. Its inherent flexibility and data-driven approach make the system ideal for evolving rapidly into FDA’s new regulatory approach.

Supporting this journey up the maturity scale, EQMS applications built on Salesforce bring high levels of connectivity, a vital feature when the appraisal model is applied within a medical device organization.

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.

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