Kymanox® provided comprehensive Quality Assurance (QA) and Quality Control (QC) support to Greenlight Biosciences, Inc. in support of clinical manufacturing. This support included reviewing and closing deviations that have batch impact, revitalizing the deviation process to streamline and simplify it to a more phase-appropriate approach, and training of deviation writers to ensure deviations are consistently written.
Streamlining the deviation process to improve efficiency.
Kymanox created an excel deviation tracker to facilitate prioritization, metrics, and organization of deviations to meet due dates.
When this project began, there were 13 open deviations which increased to 26 deviations. Kymanox helped close 14 deviations with a 70% completion rate. Kymanox helped to establish weekly triage meetings for the manufacturing and QC departments and trained Greenlight employees on the process of closing section one (the initial impact assessment) quickly and spending more time on the investigation portion. Nearly all deviations are now in section three (root cause analysis).