Advanced eQMS: The Next Generation of Quality in BioPharma

Whether taken regularly or administered in an emergency setting, many consumers’ lives depend on medicines to be reliably effective, consistently safe, and available when needed. All participants involved in the clinical product ecosystem and supply chain including sponsors, suppliers, CROs, clinical sites and stakeholders have a role to play in ensuring product quality throughout the product lifecycle. Adopting updated quality management technology is a foundational step that has multiple benefits: first, from a business perspective, enhancing product quality almost always results in higher enterprise value; second, implementing automated quality processes, policies and systems can reinforce a culture of quality throughout the product ecosystem, a core concept underlying many new government agency regulatory requirements related to quality management systems and the clinical product lifecycle.

A quality management system (QMS) is a formalized system of documented processes and procedures that outline an organization’s responsibilities and guide activities to meet customer expectations and regulatory requirements. Basic QMS approaches focus on compliance with U.S. Food and Drug Administration (FDA’s) Current Good Manufacturing Practice (cGMP) guidelines and collect general operational metrics, providing reactive solutions when issues arise.

Spurred by an increased incidence of drug shortages and supply chain issues in 2019, the FDA endorsed the adoption of “mature quality systems that focus on continuous improvement and early detection” of potential obstacles through the collection of quality metrics data. Thus, the development of stronger, more advanced electronic QMS (eQMS) platforms has provided a valuable opportunity for organizations to automatically extract critical information from their processes to guide improvement, provide transparency into the market for purchasers, and reduce the likelihood of quality-related issues throughout the clinical operations pipeline.

In this article, we’ll review how advanced eQMS adoption can improve product quality, enable sustainable compliance, foster continuous improvement and create a culture of quality that will make a positive impact for every stakeholder involved in the pharmaceutical product lifecycle.

A foundational component of clinical integrity & efficiency

The evolution of QMS from legacy paper-hybrid systems and standalone, on-premises digital systems into cloud-based, advanced eQMS can enhance clinical development and manufacturing in several areas. Advanced eQMS not only provides more detailed quality metrics, but it also ensures the integrity of all data points and exchanges throughout the pipeline.

To understand the value of this shift, we can consider grocery stores. In the past, a cashier had to manually enter individual prices for each item as a customer checked out. This was a slow process, and every entry presented an opportunity for human error as the cashier typed at the register. Every mistake required time to correct, and impatient customers experiencing these errors could lose trust or satisfaction with the store.

A legacy paper-hybrid QMS presents similar limitations: physical documentation is at risk for human error such as missing signatures, misreported values, or even lost documents. Since the introduction of barcode scans in grocery stores, quality has improved, and a grocery store can aggregate detailed information about customers’ buying patterns. Similarly, advanced eQMS automatically captures detailed information on quality processes and ensures the veracity of those data. By extending the eQMS ecosystem to stakeholders inside and outside of an organization, third parties can directly interact with the cloud-based platform rather than having to rely on less secure methods, such as email. Additionally, eQMS guarantees the accuracy of an audit trail, providing additional assurance of data quality at every step.

Prioritizing safety for patients and consumers

Advanced eQMS also provides value for patients and consumers by reducing the risk of drug shortages or quality issues. Unlike a centralized, on-premises QMS platform, cloud-based eQMS connects all stakeholders throughout clinical development and manufacturing pipeline to enable real-time information sharing. This detailed flow of data and specific metrics is critical for product quality and, in turn, consumer safety.

With a reliable record of quality for all product components at every stage, patients can have confidence in every dose of a drug. If a manufacturer or supplier encounters a problem that would compromise patient safety, they can immediately report it across the pipeline, allowing the relevant parties to take action. For example, a supplier could instantly notify all participants throughout the entire clinical operations supply chain of a recall on a specific batch of vials, reducing the risk of patients receiving a potentially hazardous product.

Advanced eQMS can also offer insights into potential causes of such issues, allowing stakeholders to intervene before production is disrupted. By collecting advanced metrics, manufacturers can use data-driven approaches to identify pain points at every stage and continually improve performance and efficiency. As a result, patients can rely on consistent product safety, quality and availability.

Demonstrated utility for decentralization

Advanced eQMS is also critical for supporting decentralized clinical operations. The COVID-19 pandemic illustrated the need for an efficient way to complete training, access records, and gather signatures without meeting in person or sending physical documentation. A cloud-based eQMS allows all parties to share and access information while maintaining regulatory compliance, regardless of their physical location or affiliation. With organizations moving to multiple cloud providers and systems within a single company, connectivity between multiple cloud-based systems has become increasingly important to facilitate seamless clinical data sharing, analysis, reporting and trending for key quality metrics which are recently being mandated by regulatory agencies.

With a connected, centralized and accessible quality data repository, all clinical quality records can be better organized and immediately available to every stakeholder in the clinical ecosystem, which is not possible with legacy or on-premises digital QMS. In short, an extensive knowledge base can be shared immediately with all parties in the ecosystem, no matter their affiliation or location. Whether it’s a product recall, an adverse event, or simply training a new employee on necessary materials, advanced eQMS can support enhanced operational efficiencies through automated data centralization and centralized reporting, trending and metrics for all parties across the clinical ecosystem.

How will advanced eQMS drive pharma forward?

In 2020, FDA introduced the Quality Management Maturity (QMM) Pilot Program, which sought to objectively evaluate the state of QMS for drug manufacturers. In this program, facilities throughout the pharmaceutical pipeline are assessed and rewarded for mature quality management practices, with an emphasis on robust quality metrics and continual data-driven improvement. Advanced eQMS adoption is a cornerstone of QMM, providing insights into manufacturing timelines, patterns in stakeholder relationships across the pipeline, and more. These data trends allow facilities to anticipate potential obstacles and intervene proactively, ensuring a robust supply chain. With fewer disruptions, inefficiencies or errors, organizations can do their best work in delivering quality products to the patients who need them.

Advanced eQMS adoption will also fuel innovation from smaller players in the pharmaceutical sphere. Cloud-based systems are faster to implement and more flexible for growth than legacy systems, and no longer require dedicated software installation on specific computers in the organization. Instead, players inside and outside the organization alike can access advanced eQMS and operations can easily scale up as the company grows.

Though implementing a new QMS may incur significant costs upfront, adopting advanced eQMS technologies that are connected, centralized, flexible, extensible and open provides a meaningful return on investment. Reductions in human error and opportunities for continual process improvement can also equate to reduced costs and adopting advanced eQMS adds significant enterprise value for even the smallest companies. Prioritizing quality management reflects a commitment to making high-quality drug products in a consistent and reliable way that benefits all stakeholders in the clinical quality ecosystem. A strong record of quality for every product component at every step will continue to foster a pharmaceutical pipeline that patients can trust.