Kari Miller Senior Director, Product Management, QMS IQVIA
In today’s life science industry, the adoption of digital technologies for greater efficiency and compliance has become commonly accepted, whether it is the patient using apps and wearables that report data to healthcare providers or data analytics for overall management, insights and trending. Quality management is no exception as teams embrace technologies to drive innovation and remove error-prone, labor-intensive paper-based systems or standalone solutions. Electronic quality management systems (eQMS) help instill quality principles into the overall culture of an organization, aiding in the achievement of harmonized policies, processes, and procedures. As a result, organizations are better positioned for growth, employee alignment and adherence to ever-changing regulatory policies. Those with paper-based systems will struggle to keep up with the rapid pace of change in regulatory requirements and the competitive edge technology provides other organizations.
Automating quality management operations brings better efficiency and consistency across a life science organization. The challenge in embracing a digital system is often as simple as individuals facing the reluctance to change from the traditional paper-based systems. So, even though paper-based systems have their own challenges and drawbacks, change is uncomfortable. These paper-based system issues include the need for greater manual administration, costly maintenance dependent on headcount and data errors due to how the information is collected, documented and then retrieved. Siloed systems have most of the same issues.
A digital eQMS brings a consistent methodology into the quality process, eliminating many of the prior challenges. It allows for flexibility for future innovations and accommodates current technologies, allowing necessary scalability, parallel processing and efficiency that paper processes are unable to provide. This singular, integrated environment manages and tracks QMS processes to simplify operations while also reducing risk and accelerating deployment. The shift to digital quality processes from paper will require operational, functional and departmental changes, in addition to cultural change.
Life science organizations that embrace comprehensive electronic quality solutions for true digital transformation and innovation require a change management process that integrates quality into the core culture. Engaging employees from the start through seeking individual insights will lead to better adoption. In the instance of one multinational life sciences manufacturer, they found that harmonization was essential as they built out their eQMS. This involved gathering input from stakeholders from across the various divisions and offices around the globe, ensuring that each employee’s voice was captured and incorporating their input on important processes. This led to employees embracing the system. As components were tested and implemented, continuous feedback was gathered, and all employees had a sense of ownership in the initiative. Early and ongoing participation brought a sense of harmonization rather than a standardization mandate that IT or management pushed down.
When introducing digital eQMS to your organization, there are several common challenges to avoid throughout the deployment process. Outside of culture and adoption, the quality team must build a future-focused organization to process data in near real-time while also analyzing historical events to be proactive, preventative and predictive.
Five Pitfalls to Avoid When Digitizing Quality Processes
For a successful journey from paper to digital, or even from siloed to integrated processes, it is key that organizations do not look for shortcuts – adaptation to the change takes time and planned change management. Organizations should work to avoid the following five dangers when implementing a digital eQMS.
1. Lacking a detailed roadmap
Teams need to develop and follow a detailed roadmap to correctly implement a fully integrated eQMS. This roadmap must include process harmonization and configuration, data migration and integration, a focus on project management, training, validation, testing and go-live support. Capturing employee feedback through the implementation is essential to ensure everyone is engaged. By harmonizing rather than mandating standardization, adoption increases and quality is built into the culture of the organization through inclusion.
2. Rebuilding paper-based systems or siloed processes as is within a digital eQMS
When attempting to quickly shift to digital processes, many organizations begin by automating current paper processes. This approach tends to weave many paper-based inefficiencies into the new digital procedures such as sequential processing. Siloed processes also build in inefficiencies by not leveraging opportunities to eliminate duplicate efforts.
3. Ineffectively managing expectations and scope creep
Prior to the full shift, it is key to touch base with every department that is involved in the quality management system. Teams may see an opportunity to move their department into the new system without being included in the core project plan. Clear internal expectations for the process and the rollout plan can reduce the risk of scope creep or disagreements over what should be included in the system. It may be necessary to pause the process and regroup so that the scope of the project is clear, and all departments agree to the roadmap.
4. Avoiding migration planning
Organizing and uploading current documentation and information are two integral steps in moving paper out of the quality. Avoiding internal conflict on what needs to be brought forward from paper-based systems is key to the success of migrating and integrating all data into the new system. Additionally, when bringing together multiple systems, there will be some aspects that will not carry over. While this can cause conflict, a solid plan with appropriate rationale for what will be included can deter from bringing outdated quality and compliance approaches into the future. These outdated approaches can limit the value of the new system and inhibit growth and innovation. As not all systems will be brought forward, not all legacy data needs to be shifted into the new system. Clear communication and planning will help to alleviate concerns over what will and will not migrate over.
5. Failing to communicate openly and in detail
Successful eQMS implementation relies on communication between teams and stakeholders. Communication and resource management will be imperative as teams must keep the business functioning during the implementation process. Communication channels should be created from the start, along with formal processes for feedback and conflict resolution, to aid in achieving target dates. Ensuring all departments involved know how the organization is moving forward, what is expected from all parties and how to resolve roadblocks or conflict during implementation and validation is key to the success of the culminating rollout.
Additionally, a lack of interest among leaders or poorly managed internal communications can cause adoption to lag. The impact of the changes must be understood and supported throughout the entire organization. Change control must be treated as an ongoing activity with processes in place to monitor the impact and effect of all outcomes.
Successful Deployment Outlook
Moving to a digital eQMS is not as simple as it seems. It requires proper, detailed planning, a comprehensive roadmap and clear communication throughout the implementation process and beyond.
By harmonizing the processes, policies and procedures during the onset, these initiatives have a greater chance of achieving the anticipated improvements to operations, quality and patient outcomes.
It is time to embrace digital eQMS to drive the quality and safety of products and improve operations. Traditional paper-based methods may allow for compliance; however, they will very likely fall short regarding efficiency, productivity and continuous improvement. Successful eQMS implementations will improve operational efficiencies, increase revenue and patient satisfaction, reduce non-conformance in manufacturing and support continuous improvement. Furthermore, going digital allows for the use of technologies that will enable organizations to do more with less, solving business problems at a more rapid pace through improved detection, trending and decision support. Technology will allow for innovation to arise in ways that just cannot be supported by paper-based or disparate system implementations.
Author Biography
As regulatory and product management leader for IQVIA Quality Compliance, Kari Miller is responsible for driving strategic product direction and delivering 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 is also responsible for the quality compliance product road map, product partner relationships, and overall product direction. Miller earned bachelor’s degrees in business administration and psychology from Marian College, Fond du Lac, Wisconsin.
Publication Detail
This article appeared in American Pharmaceutical Review:
Vol. 26, No. 8
Nov/Dec 2023
Pages: 80-81
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