Case Study: Akadeum Life Sciences achieves a 99% reduction in quality admin time and a culture of quality ownership with Qualio

Transforming quality from one manager's problem to everyone's success

Akadeum Life Sciences, a medical‑device company that uses flotation‑based microbubble technology to isolate biological targets, was struggling with a paper‑and‑spreadsheet QMS when Quality Assurance Manager Angela Pinkston joined in June 2022. Routine tasks—document revisions, PDF conversion, DocuSign signatures and manual training assignments—created duplicate effort and consumed hours or days. Akadeum selected Qualio as a cloud‑based eQMS to manage Documents, Training and Suppliers and meet FDA 21 CFR 820 and ISO 13485 requirements.

Qualio was implemented in a seamless three‑month rollout, digitizing document control, training and supplier management and enabling a single cloud source of truth. The move delivered measurable impact: a reported ~99% reduction in quality admin time, 99% on‑time training, 100% of document/training/supplier activity managed in Qualio, and a dramatic boost in job satisfaction and quality ownership across the company. Qualio also helped Akadeum build a complete design history file and freed Angela to focus on audits, validation and expanding use of Qualio Events for CAPAs and calibrations.

Akadeum Life Sciences

Angela Pinkston

Quality Assurance Manager