Case Study: IRISYS achieves streamlined QA and FDA-ready compliance with Qualio

IRISYS Uses Qualio to Help Biotech and Pharmaceutical Firms Secure FDA Approval

Irisys, a San Diego–based CDMO that helps biotech and pharmaceutical firms develop, manufacture and secure FDA approval for clinical drugs and formulations, was hampered by a manual, paper‑based quality system as it grew from roughly 10 to 50 employees. The company needed an efficient eQMS to replace time‑consuming SOP printing, signing and scanning, so after evaluating multiple vendors Irisys selected Qualio as their electronic quality management solution.

Qualio’s user‑friendly eQMS and responsive support helped Irisys migrate 500+ documents, standardize SOPs, speed QA workflows (including remote collaboration), and simplify operations; the company now runs Qualio with about 75 users on the Growth plan, has passed FDA/FDB/DEA audits without issues, and says Qualio positions them to scale to hundreds more employees while keeping QA lean.

Irisys

Adolfo Ramirez

Director of Information Systems and Data Compliance