Digital eQMS: Addressing the Main Hurdles to Success (Part 3 of 3)
In the final part of this three-part series, we look at the main hurdles to successful implementation of eQMS and ways to overcome them.
- By Kari Miller
- June 22, 2022
Digital innovation continues to play an important role in both day-to-day operations and long-term strategy development for life science organizations. Few business units have experienced this transition as dramatically as quality management, where longstanding paper-based documentation processes are increasingly being replaced with digital enterprise quality management systems, or digital eQMS.
The first article in this series outlined the primary value proposition for digital eQMS. The second installment covered three key priorities for organizations implementing a new digital eQMS. This third and final installment in the series discusses the main hurdles organizations can expect to encounter as they transition away from paper.
New technology always presents challenges to the life science industry, and digital eQMS is no exception. Organizations should be prepared to address culture shifts, data management needs, and the potential for additional investments needed to support digital eQMS.
Navigate Culture Change
“If Quality didn’t document it, then it didn’t happen.” This old maxim still applies, but in an era when real-time data analysis is the foundation of product quality and patient safety, quality management needs a faster way to document events.
To expedite the transition to digital eQMS, organizations may be tempted to automate current paper processes into new digital workflows. Unfortunately, this approach only replicates the inefficiencies of the paper process -- including data re-entry, sequential processing (as opposed to parallel processing), the need for multiple approval cycles, and print controls -- in the new digital process.
Instead, organizations should use the implementation of digital eQMS as an opportunity to reexamine quality processes. In many ways, this is an exercise in change management because longstanding paper-based processes will have to be shed in favor of more efficient -- but unfamiliar -- digital workflows. The larger the organization, the more it is likely to need to change.
For many stakeholders in quality management, this will represent a significant cultural shift. If it is not properly addressed, it could even be interpreted as a threat. To limit resistance, and to encourage the adoption of digital eQMS, emphasize the value of the work being done and focus on the many benefits that digitization will bring, from reduced costs and shorter cycle times to increased flexibility and streamlined processes.
Manage, Secure, and Validate Data
As with any enterprise system, digital eQMS creates and consumes large volumes of data. Life science organizations should ensure that their hardware infrastructure can support both storing data and analyzing it in real-time. If public cloud services will be used, it is worth looking closely at cloud supplier contracts to avoid overage fees.
Given the use of protected health information, personally identifiable information, and other sensitive data sources in quality management workflows, organizations also need to take data security seriously. To comply with the Health Insurance Portability and Accountability Act (HIPAA), for example, data should be encrypted at rest, in transit, and in use. Organizations should also place strict limits on who can access what data because this will help prevent accidental or intentional breaches. This is especially prudent for any external stakeholders who need access to the digital eQMS to perform their jobs.
Data validation is a third concern for organizations implementing digital eQMS and transitioning to electronic workflows. Governing bodies such as the U.S. Food and Drug Administration (FDA) require data accuracy to be validated at various stages of the quality management process. Updates to software -- which occur far more frequently than updates to manual quality management systems -- drive the need for additional validation to ensure compliance. Here, organizations must remain in close contact with their digital eQMS vendors to identify new software features and assess potential risks that may result from them.
Invest to Support Digital eQMS
As with any enterprise software, the total cost associated with digital eQMS is more than the price paid to acquire and install the system. To assess the true cost of digital eQMS -- a critical step for measuring ROI -- organizations need to consider the additional investments that support the system.
As noted, there will be hardware and other infrastructure costs, though some of those costs will be baked into the cost of a SaaS installation. Beyond technology, organizations will likely need to invest in staff to maintain the digital eQMS, as well as allot resources for training to help employees use the system effectively. In addition, organizations should consider the “cost” of change management, such as a short-term decrease in productivity as the new digital eQMS is brought online and staff are learning to use it.
However, organizations should keep in mind that this investment cost will be offset by increased operational efficiency and increased productivity as a result of optimized processes.
Although life sciences organizations have traditionally been slow to embrace digital technology, they have picked up the pace in recent years. This is particularly true in quality management because the growing demand for software-based medical devices requires a real-time, data-driven approach to product quality and safety before, during, and after launch.
Digital eQMS represents an opportunity for life science organizations to transition away from longstanding paper-based documentation processes that increasingly fall short as data validation, compliance, and pharmaceutical manufacturing as a whole continue to modernize. Organizations will face a technology learning curve and may encounter some resistance to change. However, they can expect to see value as soon as they deploy their digital eQMS model, and the benefits of operational efficiency, lower costs, increased revenue, and improved compliance will continue to add up over time.
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.