Case Study: Cogstate cuts ISO audit prep time by 50% with Qualio

How Cogstate cut ISO audit prep in half and is tripling its compliance coverage with Qualio

Cogstate, a neuroscience endpoint company serving clinical trial sponsors, faced a manual and time-consuming compliance process. Tracking requirements in spreadsheets and preparing for audits clause-by-clause was so labor-intensive that the team could only pursue one new certification standard per year. They implemented Qualio's Compliance Intelligence to automate and streamline their quality management.

With Qualio, Cogstate cut its ISO 9001 surveillance audit preparation time by 50%. The solution provided always-on gap visibility, enabling the same lean QA team to predict over 70% of auditor findings in advance and simultaneously achieve compliance readiness across three additional frameworks, including ISO 13485 and ISO 27001. Qualio’s cross-standard mapping also revealed the company was already 83% compliant with ISO 13485, saving months of groundwork.

Cogstate