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Digital eQMS: Implementation Priorities for Organizations Making the Transition (Part 2 of 3)

In the second part of this three-part series, we examine organizations beginning to implement digital eQMS and discuss key priorities for them to keep in mind.

The transition from paper-based to digital enterprise quality management systems (eQMS) is an important one for life science organizations, amid the industry’s increased reliance on digital innovation to reshape business processes throughout product development and treatment. This shift is not without its challenges because business processes change and corporate culture is forced to adapt. However, increased adoption of technology throughout the pharmaceutical life cycle increasingly requires a modern, digital approach to quality management.

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The first installment in our series discussed the value proposition of digital eQMS for pharmaceutical production, particularly as compared to traditional paper-based QMS. This article discusses the main priorities for life science organizations implementing a digital eQMS system. The third installment will explore key considerations and potential hurdles as system implementation progresses.

Top Implementation Priorities: Integration, Notification, Access

One factor that eases the transition from paper-based to digital eQMS is the automated enforcement of rules. By its very nature, quality management is a formalized and methodical process of detecting defects, eliminating waste, improving efficiency, and ensuring safety.

Quality management relies on rules-based workflows to manage the processes used in the production of a product, supporting an organization’s ability to comply with industry standards and regulatory requirements. This translates well to digital eQMS because rules-based automated workflows are the backbone of this technology.

However, as with any enterprise software implementation, getting a digital eQMS system up and running is more than a matter of turning it on and using it. One significant obstacle organizations face in enabling digital eQMS is the cultural shift an organization must make.

Integration with Enterprise Systems

Quality management does not occur in isolation within the life science organization and the digital eQMS is not used in isolation either. It is critical for organizations to integrate these systems with other enterprise software applications, from enterprise resource planning to product life cycle management to supply chain management. This ensures data visibility and transparency throughout the enterprise. It also makes sure that quality management’s master data is in sync with other systems. This integration allows for synchronization of business strategy and decision-making across traditionally siloed disciplines within the organization.

Technology teams should be sure that each integration between the digital eQMS and an enterprise application is stable, secure, and bidirectional. If integrations are not seamless, then business users may continue to rely on paper-based workflows as their workaround -- and enterprise-wide progress in digital innovation will stall.

Notifications Across the Quality Workflow

Because many business stakeholders are unlikely to use the digital eQMS on a day-to-day basis, it is important to enable alerts and notifications from the digital eQMS to the relevant enterprise applications stakeholders most frequently use. Real-time notifications serve multiple functions: they document the quality management process, keep production on track, and provide business leaders with the information they need to take preventive action instead of forcing course correction after the fact.

Notifications should cover the entire quality management life cycle, including pre-market concerns, key milestones, regulatory audits, go-to-market deadlines, and any post-market events. Organizations should also consider multiple methods of delivering alerts, such as desktop, mobile, and email alerts, both to align with users’ preferences and to make it easier to access information and close feedback loops.

Secure Access to Digital eQMS

Since the spring of 2020, life science organizations have seen an extensive increase in remote work. For quality management, this means that both internal and external stakeholders, such as auditors, consultants, and other contractors, will need access to the digital eQMS at certain times. Giving all parties direct access to the system is not recommended, as the eQMS contains valuable intellectual property that could be deliberately or accidentally accessed by the wrong person.

Tools such as quality portals can provide access to the eQMS data and transactions without giving direct access to the main eQMS server to third-party participants such as suppliers or auditors. Additionally, setting up remote access for employees via a secured internet connection and private virtual network will also be critical. Additional security considerations include role-based access to the digital eQMS, which limits user access to only the parts of the application they need to use to do their job, and multifactor authentication, which requires users to log in with an access code or PIN in addition to a username or password. Written guideless and appropriate training on the remote use of the digital eQMS are a must as well.

Creating a More Mature Culture of Quality

By ensuring that the digital eQMS can integrate with other enterprise software applications, send real-time alerts to key stakeholders, and allow secure remote access to relevant users, life science organizations will position themselves to advance the maturity of their quality culture. Quality can evolve from a reactive, compliance-driven process to one that is proactive, harmonized across the enterprise, and optimized to anticipate and mitigate risk.

More mature quality management leads to measurable improvement in quality metrics. These include, but are not limited to, operational efficiency, improved equipment effectiveness, cost reduction, revenue increase, a higher success rate for new product introductions, and improved compliance.

As this article has discussed, achieving this success requires the prioritization of application integration, notifications and alerts, and remote access when implementing the digital eQMS. However, there are additional technical as well as cultural hurdles that an organization must consider, which the next article in this series will address.

About the Author

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.

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