Alvotech is a rapidly growing biotech focused on delivering high quality, cost competitive products to patients worldwide. To set new standards in biosimilar medicines, the company needed to improve the efficiency and effectiveness of GxP training. Alvotech’s standalone learning management system did not allow for automated curriculum development or training assignment based on SOP changes and other quality events. Instead, training administrators had to track updates to controlled documents and then revise curricula and training assignments manually—an inefficient process that increased operational overhead and the risk of noncompliance.
Automated training assignments replace manual processes
Alvotech saw the opportunity to bring together training and quality documents in a single system to streamline document and training management. The company extended its Vault QualityDocs implementation with Vault Training, improving the efficiency and effectiveness of GxP training. The built-in automation enabled by unification allows Alvotech to create documents, deliver training, and track progress in the same workflow. For example, when Alvotech’s quality team approves a revised SOP, the system automatically generates a new training task for all relevant employees and cancels any open tasks for the superseded version. In this way, Alvotech ensures that GxP training remains tightly aligned with qualification requirements.
“This vision of unified quality is appealing. All processes are in one system, which allows for automation to be baked into the standard product.” – Andres Nielsen, Quality Management, Alvotech
Alvotech uses Vault Training to manage blended curricula of documents and videos. Flexible training matrices allows the company to assign training based on roles, improving training and quality outcomes. Digital completions are captured using read and understand, attendance verification, and other mechanisms to ensure a complete learning record. At any time, employees and managers can easily see what training is required to perform a specific function and the current training status.
Linking training and QMS processes
The company also plans to replace paper-based competency assessments with Vault Training’s online quizzes. In addition, Alvotech plans to leverage linkages between Vault Training and Vault QMS to easily trigger training as part of corrective and preventive action (CAPA) workflows. With unified training across the Vault Quality Suite, Alvotech can further improve training outcomes, efficiency, and compliance.