Optimizing Training and Compliance: Insights from Editas, Minaris, and ReciBioPharm
Quality, IT, and training leaders often face a difficult balancing act: delivering training that meets the needs of their organizations while providing an efficient learner and admin experience.
Disconnected systems, requiring complex and costly integrations, often create inefficiencies. Life sciences organizations have long struggled to manage disparate document and learning management systems. Quality and IT teams had to invest significant effort in understanding and managing document version control, and their lack of visibility of completed training created compliance risks.
Three quality leaders share the rationale and potential opportunities of choosing Veeva Vault Quality to unify document and training processes. As they explain, using one end-to-end training solution provides a better experience for all users and enhances compliance.
Letting go of legacy thinking
Companies often struggle to align their business and training objectives, particularly if they are trying to scale manual training processes across their organizations.
Jennifer DiMinni is the head of documentation ITQA and training at Minaris, a global contract development and manufacturing organization (CDMO) dedicated to cell and gene therapies. She noticed that her company’s legacy system introduced delays and complexity where efficiency was most needed. Training administrators “couldn’t complete key parts of their work, such as generating data, and reporting was another obstacle for us.”
Time is the most precious resource for small and midsized companies, and it can easily be consumed by managing multiple vendors and contracts or navigating non-coordinated release cycles across several systems. This is particularly problematic for virtual organizations that rely on outsourcing and, as a result, maintain limited IT and quality footprints.
Editas, a gene editing company, also found that having L&D and non-GxP training in a separate training system duplicated learners’ training requirements and complicated reporting. ReciBioPharm (a biologics CDMO) was similarly motivated to consolidate its applications. Shauna Greene, associate director for training and document management at ReciBioPharm, notes: “It helps to have everything in one place. Managing your document and training processes within the same environment is more cost-effective, and efficient for users.”
Simplicity as your guiding principle
As Vault Training can support GxP and non-GxP-related training, companies often find it simplifies their entire training landscape.
Through simplified workflows, Minaris manages the lifecycle of its non-GxP training content in Vault QualityDocs and developed a comprehensive training matrix within Vault Training. This made it easier to organize training across users. “Migrating all of our GxP and non-GxP content into Vault was a game changer. Managers and technical trainers all know how to export reports in Veeva and need minimal additional training,” explains DiMinni. “They have the ability to report on the full training history for each learner.”
Administrative productivity quickly improved once Minaris implemented Vault Training and QualityDocs. Training administrators can more easily build training matrices for the organization and pull data together when compiling reports for customers, managers, or auditors.
Consolidating all training into one system empowers learners to easily access and complete role-specific compliance and non-compliance training assignments. This eliminates the need for multiple logins, enhancing efficiency and user satisfaction through a familiar Vault interface.
By leveraging the latest features, teams can simplify learning and development for their organizations. ReciBioPharm is using dynamic enrollment and curriculum matching to streamline its training assignment process. This ensures the right content reaches the right learners and facilitates the deployment of the latest LearnGxP courses.
Many paths to migration
Transitioning from siloed applications to a unified training solution requires executive buy-in. A strong business case should highlight existing challenges and outline the potential benefits of a consolidated approach. DiMinni’s team at Minaris, for example, explained the advantages of a unified document and learning management system to senior management. “Thinking holistically about the benefits of having everything in one system, it was a no-brainer for us,” DiMinni recalls.
Once you have the go-ahead, there are many ways of implementing Vault Quality across your organization: from a soft launch in one market ahead of a general rollout to migrating everything at once. Minaris, for example, took the approach of a phased migration starting in Japan before expanding worldwide.
Soft launching at a smaller facility was “a bit like a boot camp” for training admins, who gained valuable experience using the system. DiMinni recalls: “It meant dedicated focus for several weeks to build out the curricula, training requirements, and learner roles.”
Clear analysis will prompt candid conversations. Minaris revisited role expectations and individual training requirements while considering the cost-benefit calculation for the business. With the implementation of Vault QMS, QualityDocs, and Training, ReciBioPharm gained the ability to pinpoint learners’ involvement in critical quality processes. This facilitates a comprehensive view of each user’s training requirements to ensure they are adequately qualified. “It should be clear in the actual procedure who plays a role in that particular process and those are the folks who should be assigned to training,” Greene points out.
Creating a virtuous circle
Strategic decisions can expedite migration. After working closely with Veeva’s professional services team, one company prioritized migrating only active employee training records to Vault Training. Historical records were then extracted and securely stored within Vault QualityDocs, reducing the overall migration scope and accelerating implementation.
Having successfully implemented Vault Training and QualityDocs, DiMinni also credits close collaboration with the Veeva team for the smooth progress to date. She concludes, “What pushed our company to go with Veeva was the level of support. They genuinely want to know what the pain points are to improve their system for the betterment of your business. Frankly, that is unparalleled to any other company I’ve worked with to date.”
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