Process alignment across all our safety assessment sites is critical to ensure we meet our clients’ needs. As Charles River continues to grow, we continue to further optimize the alignment of our global quality assurance group’s procedures to consistently provide quality products as well as prompt delivery of those products to our clients.
To accomplish this goal, a streamlined approach to the audit concept was introduced as a harmonized standard operating procedure (SOP) for QA to meet the vision and ensure attention to efficient fulfillment of regulatory deliverables. The challenge lay in ensuring the SOP contained sufficient detail, while allowing sites the flexibility to determine their critical factors that may result in higher or lower levels of auditing based on the process specific to each site.
Our solution was for each site to develop their own audit plan after a review of historical audit trends, validated systems, and robustness of QC functionality. The audit plan was then harmonized and shared across sites, while still allowing for site specific flexibility. This allows resources to be utilized when needed at different sites and ensures audits are completed in alignment with clients’ timelines.
Learn more about our Global Process Adoption initiative.