
Sustaining a culture of compliance.
Aragen’s robust quality systems across our various facilities ensure that customers can expect the same quality standards irrespective of location. While a quality leadership team, we firmly believe that quality is everyone’s responsibility. From senior management to the shop floor, we are all equally committed to delivering zero-defect products to customers, on time, and in full.
To meet the standards that our customers have come to expect from us, we:
During Fiscals 2026, 2025 and 2024, Aragen observed 288 audits, comprising 21 regulatory audits and 267 customer audits, with no adverse findings.
To ensure independent and impartial decision making, all our sites have their own quality teams that report directly to the global quality head and CEO. Corporate quality assurance (QA) focuses on developing and enforcing uniform standards across the organization on vendor management, quality control, electronic quality management system, digital initiatives (automation), management reviews, management information services, harmonization of procedures, quality compliance, training, turnaround time and quality by design.
At Aragen, we deliver products that enable our customers to make better health possible. What we do impacts lives, so as an organization, we are deeply committed to the quality, safety and effectiveness of our solutions.