Kari Miller is senior director, Product Management, QMS, IQVIA.

Kari Miller

As the saying goes, “the only constant in life is change,” and in today’s life sciences industry, that’s undoubtedly the case, as the widespread adoption of digital technologies for enhanced efficiency and regulatory compliance has become central to the evolution of the market. This evolution includes patients using apps and wearables to transmit data to healthcare providers, as well as the utilization of data analytics for comprehensive management, insights, and trend analysis.

Change is certainly a constant for global industry compliance as new or updated regulations and reference documents are published every 25 minutes worldwide—that’s almost 58 a day, or more than 21,000 documents a year. Managing and maintaining compliance requires diligent efforts to track, review, evaluate, and take necessary actions to ensure continued compliance. To that end, quality management systems (QMS) need to be able to keep up with the ever‑shifting sands of regulation. In a paper-based system, this represents a monumental task, especially as more systems become digitally transformed. With that in mind, quality management teams are embracing technologies to drive innovation and remove these error-prone, labor-intensive paper-based systems or standalone solutions.

Electronic quality management systems (eQMS) play a pivotal role in embedding quality principles throughout an organization’s culture, facilitating the establishment of uniform policies, processes, and procedures. Consequently, organizations are better positioned for growth, ensuring alignment among employees and compliance with evolving regulatory requirements. In contrast, those still reliant on paper-based systems will struggle to keep pace with the rapidly changing regulatory landscape and the competitive advantages that technology affords others.

Implementing automated quality management operations enhances efficiency and consistency within a life science organization. However, the primary hurdle to embracing digital systems often boils down to the reluctance of individuals to depart from traditional paper-based methods. While paper-based systems come with their own set of challenges and limitations, people can be naturally resistant to change. Limitations of paper-based systems include increased manual administration, costly maintenance linked to workforce requirements, and errors in data collection, documentation, and retrieval.

Similarly, siloed systems encounter many of these same problems. In contrast, a digital eQMS introduces a uniform approach to quality processes, mitigating many of the aforementioned challenges. It offers adaptability for future innovations and aligns with current technologies, allowing for essential scalability, concurrent processing, and efficiency that paper-based processes cannot match. This integrated environment manages and monitors QMS processes, streamlining operations, reducing risk, and expediting deployment.

Moving from paper-based to digital quality processes requires changes in operations, functions, and departments, as well as a shift in the organization’s culture. Life science organizations seeking genuine digital transformation and innovation through comprehensive electronic quality solutions must implement a change management process that ingrains quality into their core culture. Engaging employees from the outset by soliciting their individual insights is pivotal for achieving better adoption rates.

For example, one multinational life sciences manufacturer recognized the importance of harmonization as they developed their eQMS function. They took the initiative to gather input from stakeholders across various divisions and global offices, ensuring that each employee’s voice was heard, and their input was integrated into critical processes. This approach led to enthusiastic employee adoption of the system.

Continuous feedback was collected as components were tested and implemented, giving all employees a sense of ownership over the initiative. In contrast to management’s or IT’s one-size-fits-all standardization, early and ongoing participation promoted a harmonious environment. When introducing a digital eQMS to an organization, there are several common challenges to avoid during the deployment process. Beyond addressing cultural and adoption issues, the quality team must establish an organization with a forward-looking approach to process data in near real-time and analyze historical data for proactive, preventative, and predictive measures.

Five common mistakes to steer clear of when implementing digital quality processes

To ensure a successful transition from paper-based or siloed processes to a digital environment, organizations must avoid these five common pitfalls when implementing a digital eQMS:

Lack of a comprehensive roadmap. It is essential to develop and adhere to a detailed roadmap for the seamless implementation of a fully integrated eQMS. This roadmap should encompass aspects like process harmonization, configuration, data migration, integration, project management, training, validation, testing, and go-live support. Encouraging employee feedback during implementation is crucial to keeping everyone engaged. Emphasizing harmonization over strict standardization fosters adoption and instils a culture of quality within the organization through inclusivity.

Replicating paper-based or siloed processes in the digital eQMS. Rushing into digitization often leads organizations to automate existing paper-based processes, inadvertently carrying over inefficiencies. This can result in issues such as sequential processing. Similarly, siloed processes tend to retain inefficiencies by failing to capitalize on opportunities for streamlining.

Inadequate management of expectations and scope creep. Before the full transition, it’s important to engage with every department involved in the QMS. Some teams may attempt to integrate themselves into the new system without proper inclusion in the core project plan. Setting clear internal expectations for the process and rollout plan can mitigate the risk of scope creep and disagreements about the system’s scope. In some cases, it may be necessary to pause the process and regroup to ensure alignment among all departments and adherence to the roadmap.

Neglecting migration planning. Proper organization and migration of existing documentation and information are crucial steps in the process of moving from paper-based systems. Avoiding internal conflicts regarding what to bring forward from paper-based systems is vital for the success of data migration and integration into the new system. When consolidating multiple systems, certain aspects may not carry over, which can lead to conflicts. A well-defined plan with a clear rationale for what will be included helps prevent outdated quality and compliance approaches from hindering progress. Not all legacy data needs to be transferred, and open communication and planning can address concerns about what will and won’t migrate.

Inadequate and opaque communication. Successful eQMS implementation hinges on effective communication among teams and stakeholders. Establishing communication channels from the outset and creating formal processes for feedback and conflict resolution are crucial for meeting target deadlines. It is imperative that all relevant departments are aware of the organization’s forward movement, what is expected from all parties and how to address obstacles or conflicts during implementation and validation. Furthermore, leaders must show interest and actively manage internal communications to ensure a smooth adoption process. Change control should be viewed as an ongoing activity, with processes in place to monitor and assess the impact of all outcomes.

Transitioning to digital eQMS is a complex endeavor that necessitates meticulous planning, a comprehensive roadmap, and transparent communication throughout the implementation process and beyond. By aligning processes, policies, and procedures from the outset, these initiatives stand a better chance of delivering the anticipated enhancements to operational efficiency, quality, and patient outcomes.

It’s high time to embrace digital eQMS to enhance the quality and safety of products and optimize operations. Traditional paper-based methods may ensure compliance, but they often fall short in terms of efficiency, productivity, and continuous improvement. Successful eQMS implementations lead to improved operational efficiencies, increased revenue, enhanced patient satisfaction, reduced manufacturing non-conformance, and ongoing process improvement. Furthermore, digital adoption enables the use of technologies that empower organizations to achieve more with less, addressing business challenges more swiftly through improved detection, trend analysis, and decision support. Technology fosters innovation in ways that paper-based or disparate system implementations simply cannot support.

Kari Miller, senior director, Product Management, QMS, IQVIA.


Vol. 35, No. 12
December 2023
Pages: 29–30

When referring to this article, please cite it as Miller, K. Revitalizing Quality Management Processes through Digitalization. 

Articles

Eradicating paper-based workflows and standalone solutions operating in isolation provides a good starting point to update quality management processes.