Improving Quality and GxP Training Effectiveness

At the 2019 Veeva R&D Summit, experts from Foamix, Dicerna, Xeris, and Xencor came together to discuss opportunities for improving quality and GxP training effectiveness.

Automation drives training compliance

When Xeris grew from 12 people to over 200, demonstrating training compliance using paper became difficult. “Auditors and inspectors needed evidence that our employees were appropriately trained to perform their jobs,” said Ashley Gregory, corporate training manager at Xeris. “Not knowing if employees met essential requirements and completed the training on time became a compliance risk. A stack of paper couldn’t give us any insight.”

Xeris gained that insight with Vault Training, an industry-specific learning management application. Ashley added, “Now we can distribute the training on time, follow up on training completion, and trace job qualification status.”

While industry-specific learning management solutions improve training outcomes, most life sciences companies use them in disparate environments. Having different systems for managing standard operating procedures (SOPs), knowledge-management documents, and training prevents companies from developing effective training programs.

Unified document management and training solution improves training effectiveness

Unifying industry-specific learning technology with other quality applications brings unique benefits. For example, automatic assignment of training based on quality events such as CAPA workflows or document changes improves efficiency and quality.

Anthony Davis, global head of quality and compliance at Dicerna, shared how configuring curriculum review and approval workflow in a single platform streamlines document changes, related curriculum updates, and subsequent training assignments.

“In multi-system environments, training administrators have to manually track document version changes and determine when retraining is needed,” said Anthony. “A unified environment manages document and curriculum lifecycles in the same system, accelerating and simplifying training development, administration, and delivery.”

Foamix described how using Vault Training with Vault QualityDocs strengthened quality management across their US and Israeli sites. According to Maggie Enterline, senior manager at Foamix, “A unified training and document management solution automatically assigns retraining based on continuous updates of controlled documents, increasing visibility and training efficiency.”

Unifying processes across quality, content management, and learning management ensures that training remains aligned with compliance requirements and corporate strategy. The results are faster internal audit preparation and onboarding of new team members, as well as better training and quality outcomes.

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