Balancing speed, quality, and compliance practices is the key to getting life sciences products to market quickly and safely and maintaining this through post-market. But achieving that balance is a constant challenge.

Managing quality processes across product manufacturing is complicated, and it can often be challenging to maintain a focus on quality. There are many teams, processes and operating systems involved in the manufacturing of products, and without a streamlined workflow a lack of cohesion introduces delays and errors that slows progress. Within this dynamic a fully integrated electronic Quality Management System (eQMS) can be a game-changer. An eQMS provides a single, integrated digital environment to track and manage quality practices across a company’s activities. It allows the reduction of scope creep, prioritization of resources, and the creation of harmonized, transparent operating environments for quality and compliance oversight that reduces risks and accelerates deployment of customer facing processes and outputs.

In October, IQVIA ‘s Mike King, Phil Johnson, and Don Soong, hosted the second webinar in a three-part series on future-proofing quality operations, focused on how to transform your organization with fully integrated eQMS.

An eQMS roadmap

Implementing a fully integrated eQMS can be complex, however the returns of such effort are significant.  Improved regulatory compliance with enhanced risk management at reduced costs can be achieved when eQMS is deployed effectively with a supporting harmonization of operational processes. An instant flash poll of webinar attendees showed that the biggest benefits of implementing an integrated eQMS platform are improvement in compliance (43%), followed by optimization of resources (30%), and improved customer satisfaction (26%). The sooner companies deploy an eQMS, the faster these benefits can be realised. To help accelerate that journey, IQVIA's King, Soon, and Johnson laid out five common obstacles that companies face on these projects and how to avoid them.

1. Be wary of scope creep: When companies launch these projects, every department that touches the quality management system may see an opportunity to transfer their work into the new system without making it part of the core project plan. Examples of this might include making the quality management system a repository for the company's entire training and education plan or using the deployment of an eQMS as an opportunity to create a single Master Data Management (MDM) interface over a variety of disparate and uniquely structured company MDMs sitting in different ERP systems. While gathering stakeholder feedback on what must be part of the initial rollout plan is important, setting clear expectations for what will be included can reduce the risk of scope creep and arguments over what belongs.
2. Avoid debates over who has the best written processes and forms. This is a common challenge when transforming any disparate systems into a single streamlined solution. When a company brings together three or four documented systems, two or three carefully crafted systems won’t carry forward into the future state. That can cause conflict, but you must stand firm. When teams give in to pressure to copy-in outdated quality and compliance approaches from the past, it will inhibit growth and limit value in the new system. However, it is important to communicate to the process owners why their process/documentation is not being considered for the eQMS.
3. Beware functional specifications masquerading as user requirements. Sometimes within the world of Quality Assurance and Regulatory Affairs (QA/RA), we treat user requirements as functional specifications, and we don’t want to let them go. A company may also try to harmonize its product complaint management process by bringing several workflows and systems into one. In many cases, the variance needed to address the needs of the differing products can be captured through functionality within one common process rather than creating an amalgamation of the old processes. Instead of having two workflows, you can create one complaint workflow and build functionality at complaint intake that triggers you to ask different questions based on product type. So, you capture the variation within the process rather than creating additional processes for each variation. Additionally, teams can demand requirements in a paper-based system that are unnecessary for a digital environment. They cling to cultural steps or review processes that feel like specifications but are internally developed requirements based on their customized workflow. These processes are comfortable and give teams confidence that their processes are reliable. Still, they should not be embedded into a new system unless they are a truly required specification that is needed for quality, compliance and/ or commercial objectives.
4. Communication is key. The success of an eQMS implementation depends on good communication between all teams and stakeholders. Open communication channels must be established from the outset, with formal steps to solicit and catalog feedback. This helps build buy-in and ensures course corrections can be made quickly and with team support. It also guarantees all parties involved in the project are aware of how the organization is moving forward, what the key targets are, and how lessons captured mid-deployment will affect the final rollout.
   
   Internal work teams want to hear from their leaders about what's happening, how it will affect their processes and roles, and how the future will look. You cannot rely on outside consultants to oversee these communication steps. Poorly managed communication or a lack of interest among leaders will cause buy-in to suffer and adoption will lag.
5. Pay attention to change control. Change control is a key module within the eQMS but is also key for the project.
   
   An eQMS roll-out is defined by change, so make sure the impact of that change is understood and that interconnectivity between the multitude of systems the organization may use is known. Change control has to be treated as an ongoing activity, with formal processes to monitor the impact of change and its effect on the overall outcomes.
   
   When defining a change control strategy, you need to:
• Define the overall deployment plan
• Define key priorities based on the commercial and compliance drivers
• Determine how those priorities will be phased and sequenced
• Employ a risk-based approach to reviewing and justifying any change
• Define stage gate review steps with criteria between each phase of deployment

Remember, it is often the simple changes in manufacturing or shipping that significantly impact global registrations. For example, what may be considered a nonsignificant change in the branding of labeling and packaging in the US and EU may require a registration update in global countries as the "look and feel" of the packaged product has changed. Should the new item be inspected at customs or at a customer site in the country, it may be deemed counterfeit or falsified as the external branding does not match that held in the government's registration files. In some regions, the re-registration activities to update the government records with the product changes can take several months to years with the risk that the new designed product cannot be imported until this registration update is complete. Getting your arms around change control communication is key for the successful delivery of a quality management system.

Deploying any digital platform in a quality-driven environment demands an equal balance of culture change, technical expertise, and rigorous planning and oversight. Working with reliable eQMS vendors and building a staged rollout plan from the outset helps companies avoid many of the pitfalls that derail these projects, ensuring they achieve the best investment results. Implementation of the eQMS has to be managed effectively, to ensure that the business continues functioning during this period; resource management is one of the most important factors to ensure this happens.

To learn more about IQVIA’s eQMS solutions and deployment models, visit SmartSolve® Enterprise Quality Management System - eQMS Software - IQVIA, or check out the full webinar here.