The results
Results
Cogstate, a neuroscience endpoint company serving global biopharma sponsors, cut ISO 9001 surveillance audit prep by 50%, predicted more than 70% of auditor opportunities for improvement in advance, and is now achieving compliance readiness across three more standards simultaneously, with the same QA team.
Qualio replaced Cogstate’s manual, sequential compliance process with always-on gap visibility, enabling a lean QA team to prep faster, predict more, and achieve compliance readiness with more standards at once.
| Activity | Before Qualio | After Qualio |
|---|---|---|
| Audit prep | Manual, clause-by-clause review of hundreds of documents | 50% faster; Qualio scans the full document library automatically |
| New framework gap analysis | ~1 month per standard; limited to ~1 new standard per year | Monitoring multiple frameworks (ISO 13485, ISO 27001, 21 CFR Part 11, ICH GCP E6 R3) in progress simultaneously; ISO 13485 already 83% mapped via cross-standard overlap |
| Cross-team compliance | QA and IT coordinated ISO 27001 prep via spreadsheets and Jira; technical staff often unaware of relevant procedures | Qualio surfaces gaps with remediation recommendations; non-QA teams act independently |
“Before Qualio, the level of manual effort required to pursue new certifications meant we could only take on one standard per year. Now, we’re managing multiple frameworks simultaneously and staying ahead of them.”
How it works
Cogstate serves clinical trial sponsors who regularly audit their vendors against ISO, FDA, and GxP requirements. Before Qualio, the team tracked every requirement in spreadsheets, mapping hundreds of documents clause by clause to regulatory requirements. A full gap analysis for a single framework could take several weeks.
Qualio accelerated audit prep for Cogstate’s ISO 9001 surveillance by 50%, with AI-supported gap analysis and mapping of SOPs, procedures, and records to clause-level 9001 requirements. “Before Qualio, the level of manual effort required to pursue new certifications meant we could only take on one standard per year,” said Allison Iles, Quality Engineer, Cogstate. “Now, we’re managing multiple frameworks simultaneously and staying ahead of them.”
Next, Cogstate is focused on demonstrating compliance with ISO 13485 and preparing for an ISO 27001 surveillance audit with Qualio, while simultaneously using the system to assess and monitor compliance with ICH GCP E6 R3, 21 CFR Part 11, and ISO 9001. This is allowing Cogstate to manage dozens of annual customer audits more effectively, replacing audit prep sprints with continuous visibility of compliance against regulatory requirements. Qualio’s cross-standard document mapping showed that Cogstate is already meeting more than 80% of their ISO 13485 requirements, saving the team months of groundwork. Qualio’s remediation recommendations have also extended QA’s reach: the IT team managing ISO 27001 can now act on gaps independently, without relying on QA for every question.
As Cogstate manages quality and compliance processes in Qualio, their risk analysis updates in real time.
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