Digital eQMS: The Intelligent Backbone of Quality Management (Part 1 of 3)
In the first part of this three-part series, we examine what an eQMS is, explore its benefits, and discuss what’s driving enterprises to adopt it.
- By Kari Miller
- June 20, 2022
Today’s life science industry is experiencing an exciting shift thanks to the adoption of new digital technology solutions. Ironically, although new digital solutions are regularly entering the marketplace, we are transitioning into the post-digital age in which businesses are completely reshaping their business processes to leverage new and powerful capabilities. In the life science industry, as in many industries, organizations’ downstream processes have become dependent on digital technology. From health apps and wearable tech such as smart watches to point-of-use diagnostics, there are many digital solutions to monitor health and support diagnoses and treatment of illnesses.
The use of digital devices in the life science industry will soon permeate the entire product and treatment life cycle, from research and clinical trials to manufacturing medicines, to in-person patient treatment. Pharmaceutical manufacturing quality teams that wish to keep up with the rapid pace of digital innovation in the healthcare industry must embrace data and technology to develop innovative new processes and approaches to quality management and control.
Today, paper-based quality-management systems (QMSes) are used by some organizations that have yet to transition to a digital QMS. Although a digital enterprise quality-management system (eQMS) holds many benefits for life science companies, the digital shift can be challenging due to misunderstandings in how digital technology operates and processes data, as well as a substantial change to pre-existing processes and company culture. In this article, and in two additional installments of the series, the challenges, value, and benefits of digital eQMS will be examined.
What is influencing the shift to eQMS?
Digitally-enabled manufacturing facilities (i.e., smart factories) leverage cyber-physical systems powered by AI, machine learning (ML) and data analytics to create virtual representations of real-world environments. IoT technology also plays a role by collecting and exchanging data between multiple points across an organization’s manufacturing facility and supply chain. This creates a digital environment that is integrated throughout an organization’s ecosystem and updated in real time.
Digital eQMS live within this digital ecosystem and enable the harmonization of policies, processes, procedures, and documentation for life sciences, including pharmaceuticals and medical devices. This ensures quality throughout every step of the life sciences production quality management process. However, for digital eQMS to function properly, an organization’s digital ecosystem must be treated like the backbone of life sciences manufacturing operations. As such, it should be designed like a nervous system with holistically integrated data feeds from real-world operations to make a significant positive impact on bottom-line revenue.
Why should organizations shift to digital eQMS?
A true shift to digital eQMS can be daunting. Not only is there a required cultural and training overhaul for quality management team members, but some organizations have a hard time accepting that data will be properly managed by machines and software. Although the shift to digital eQMS can be challenging, it’s necessary.
As life science organizations implement digital technology solutions in other areas of the healthcare industry, the success of those solutions will increasingly depend on digitally enabled eQMS. For instance, in pharmacovigilance operations, it is incredibly helpful to know where a particular batch of medication was manufactured or if any issues occurred in production. Furthermore (and possibly just as important as internal pressure from other life science departments and operations), some competitors have already begun implementing digital eQMS.
How should organizations shift to digital eQMS?
Although eQMS technology serves as the backbone of life sciences manufacturing quality management, the shift from paper to digital QMS requires significant investments in people and processes -- not just equipment and technology. Discuss internally how to go about change management and employee training and develop a strategy before embarking on a journey to digital eQMS.
Employee buy-in is critical because most people are initially uncomfortable with change. To proactively address these concerns, ask quality management team members about the challenges they face with today’s paper QMS. Clearly explain how digital eQMS can help overcome these challenges and know that will be a key part of retraining those employees. Once the idea of digital eQMS is introduced, talk to team members about their concerns about the transition. Work with team members to address their concerns with retraining and process changes and develop a new workflow that fits your organization’s needs.
Once these initial steps toward digital eQMS are explored, life science organizations will realize that truly elevating quality requires an enterprise-wide understanding that quality isn’t the responsibility of a single department or team. Embracing digital eQMS requires and enables everyone in the healthcare cycle to contribute to the quality of patient treatment. Consistent and efficient results provided by eQMS lead to higher quality production, which leads to higher quality products and, therefore, higher quality treatment of patients.
In the next article in this series, we will discuss additional considerations and benefits provided by digital eQMS, as well as how the capabilities are reshaping approaches to quality management.
As regulatory and product management leader for IQVIA quality compliance, Kari Miller is responsible for driving strategic product direction and delivery of industry best practices and regulatory compliance solutions for quality management. She focuses specifically on translating market and industry requirements into industry-leading enterprise quality- management solutions that meet the needs of the heavily regulated life sciences market. She also is responsible for the quality compliance product road map, product partner relationships, and overall product direction. Miller earned a Bachelor of Science in business administration and a Bachelor of Science in psychology from Marian College of Fond-du-lac, Wisconsin.