Alcon and GRAIL: Unlocking Innovation and Efficiency through Strategic Partnerships

Medtechs that achieve the greatest success with their �Թϱ�� Quality Cloud implementations take a holistic, organization-wide approach that fosters stakeholder collaboration and emphasizes continuous improvement.

Robin Farmer, senior director of compliance operations records and education at GRAIL, and Ryan Nugent, associate director of digital QARA systems at Alcon, recently shared insights about their multi-year �Թϱ�� journeys and efforts to streamline operations.

Farmer leads the quality and compliance efforts at GRAIL and ensures adherence to GDP standards as part of her ongoing commitment to a robust record keeping culture.

Nugent is the business system owner for Alcon’s 35,000 user �Թϱ�� Quality Cloud and �Թϱ�� RIM implementation. He oversees the partnership between Alcon’s business, IT, and �Թϱ��’s Managed Services team.

Clearly defined release management strategy

�Թϱ�� delivers major product enhancements three times a year through the general release Vault update process. Having a clearly defined release management and validation process ensures efficiency and optimization of the software.

Alcon, a large and mature enterprise, follows this cadence by deploying their Alcon Quality Vault updates two months after �Թϱ��’s release. This alignment gives Nugent’s team ample time to plan and turn on auto-on capability. Alcon works hand-in-hand with �Թϱ��’s Enterprise Application Management (EAM) services team to deploy new Vault releases. Development is shared by �Թϱ�� EAM and Alcon’s internal DevOps team.

GRAIL, a much smaller and newer organization, implements less frequent updates, but is continually evaluating how to deliver releases faster and more reliably. Farmer hired a clinical systems manager (CSM) to act as a liaison between internal IT, �Թϱ�� Managed Services, and �Թϱ�� user stakeholders. By centralizing release management across GRAIL’s multiple Vaults, (eTMF, CTMS, QMS, and Training), the CSM uncovers interdependencies, streamlines cross-functional processes, and promotes collaboration between teams.

“Having a system like �Թϱ�� is a luxury, and sometimes there is a misnomer that the system will automatically take care of things,” Farmer explains. “The centralized CSM role has been a game-changer for GRAIL. When we need help from �Թϱ��, we get immediate white glove service.”

Continuous user engagement and buy-in

Keeping a strong pulse on �Թϱ�� users is critical to driving strong user engagement and buy-in. User engagement measures how users interact with �Թϱ�� and is a strong indicator of satisfaction and loyalty. User buy-in or approval of a new release fosters teamwork and leads to a more successful and widely accepted release.

At Alcon, a network of 60 change agents made up of document control and training stakeholders keep a steady pulse on “everything �Թϱ��.” This team regularly conducts sessions with end users to build a high, medium, and low feature priority list based on ROI and perceived risk. Nugent’s team then works with stakeholders to incorporate this feedback into the release schedule.

Once testing and the release are complete, Alcon trains the change agent network. Training programs then cascade down to users, building excitement and awareness. �Թϱ�� Training is used to ensure learner roles and training hierarchies make sense.

Both organizations initially tracked �Թϱ�� user feedback in large spreadsheets, which became unwieldy. Alcon switched to internal IT ticketing systems, while GRAIL adopted Jira to analyze requests more efficiently. These tools now streamline the management of �Թϱ�� requests and incidents.

In addition to the Jira workflow at GRAIL, the CSM takes a significant role in evaluating user satisfaction and prioritization requests. The CSM implements weekly meetings with subject matter experts across multiple vaults and receives constant feedback through an open office hours format. This effort reduces the noise because the SMEs are informed how the process works and gives clear visibility into enhancement timelines.

Commitment to continuous improvement

GRAIL uses metrics and an annual “sense check” with �Թϱ�� to evaluate how the business is doing with their Vault implementation compared to organizations of comparable size and complexity. Metrics are crucial for measuring various aspects of business impact. GRAIL creates quality reports quarterly and compiles data such as process timeline improvements and change control metrics. For eTMF, metrics include documents in and out. GRAIL also views the volume and type of training conducted as an important measure of success.

Alcon’s enterprise is more complex. Each business evaluates common assessment metrics including quality value, regulatory impact, and the number of users that benefit. To Nugent, “We must be constantly in tune with what works for everybody. My team takes a very nuanced, give-and-take strategy to communicate continuous improvement value.”

The following tenets are central to Alcon’s continuous improvement practices:

Utilize the change agent network to keep a pulse on the user community
Ensure all stakeholders are heard in the prioritization process
Provide detailed, frequent communications to users and stakeholders
Maintain a consistent and frequent release schedule, but be realistic with give-and-take

Both Farmer and Nugent recommend that other medtechs not overcomplicate metrics and use the system as a tool to show time and effort savings.

Key Takeaways

In summary, medtechs that maximize the value of their �Թϱ�� Quality investments continually hone their release management and validation processes, support strong user engagement and buy-in, and commit to continuous improvement supported by regular metrics and benchmarking. Building strong partnerships with �Թϱ��, the user community at large, and IT helps to streamline operations and improve quality business outcomes.

To learn more about how leading medtechs are driving proactive quality and compliance, read the

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