The Future of Enterprise Quality Management Software (EQMS) – Part I

by | Aug 17, 2018 | FDA, ISO, Medical Devices, QMS

The future of enterprise quality management software is changing. Quality professionals across the globe are dealing with an astounding number of changes that correspond with new international standards and regulatory requirements, including the transition to ISO 13485:2016, ISO 9001:2015, IATF 16949:2016, as well as the upcoming transition to the new EU Medical Device Regulation (MDR). Additionally, FDA, in the recent Spring Unified Agenda, made it clear that the future goal is to harmonize and modernize regulation of Medical Device Quality Systems. The primary objective is to “reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements”.

The noted changes in the international regulatory landscape will have a direct impact on quality management system (QMS) design and implementation. Thus, this is an appropriate time to reveal a new approach to QMS thinking and analysis that will undoubtedly pave the way to the future of QMS architecture. With that said, the purpose of this white paper is to introduce some new and innovative concepts that are aimed at taking our current thinking into the future. And yes, this includes incorporating Artificial Intelligence into the design and architecture of a QMS.

In this paper, we will discuss:

  • The history and evolution of quality systems and Enterprise Quality Management Software (EQMS) platforms
  • The concept of a Self-Learning QMS, and the concept of Intelligent EQMS
  • The new QualiMeter tool and the associated unit of measurement (quality process interactions (QPI))
  • The role of artificial intelligence in the future of EQMS platforms.

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Carmine Jabri

Carmine Jabri

CEO - As co-founder of E.M.M.A. International Consulting Group, Inc., Carmine Jabri, PhD, MSJ, MSQM, MHA serves as EMMA International’s CEO. Dr. Jabri is an experienced Quality Assurance & Regulatory Affairs professional with more than twenty years of experience implementing, improving, and directing Quality Management Systems and compliance operations. His career includes expertise in the Pharmaceuticals, Medical Device and Biologics industries. Dr. Jabri serves on the Food and Drug Law Institute’s Medical Products committee and is an internationally sought-after quality systems expert. Dr. Jabri holds a Doctor of Philosophy in Epidemiology, a Master of Science in Jurisprudence, a Master of Science in Quality Management, a Master of Science in Health Services Administration, and a Bachelor of Science in Chemistry.

More Resources

Process Validation

Process Validation

All right, you have just gotten all of your paperwork together, submitted the right forms to the right people, set up your factory, hired and trained your staff; now it’s time to make the medical devices. The regulatory nonsense is over and done, right?
The Role of Management in Product Quality

The Role of Management in Product Quality

Depending on the factory, some production employees may find it surprising that management has an important role to play in a quality system.  21 CFR 820.20 mandates that “Management with executive responsibility shall establish objectives for, and commitment to, quality”.[1]  The Federal Government expects that management takes an active interest in improving the output of their company, at least in the case of medical device manufacturers.
Corrective and Preventive Action

Corrective and Preventive Action

In addition to helping manufacturers make better products, corrective and preventive actions are important because the process is legally required by the FDA when making medical devices for the US market.

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