The work gets done.
Your team approves it
Qualio's AI finds the gaps and drafts the fix, writes up the CAPA, answers what keeps recurring and why, builds the training quiz and completes the questionnaire or RFP. Every output cites the clause it applied and the record it read, and waits for your approval.

WHERE THE HOURS GO
Your systems record the work. Someone still has to do it.
Every CAPA is drafted by a person. Every clause is mapped, every requirement traced, every piece of evidence pulled, every training assignment chased, every gap found by someone reading. The systems hold the result. The hours to produce it come from quality, regulatory and engineering.
Every draft starts from a blank page
The CAPA, the change control, the training, the questionnaire, written by whoever has the evening.
Every question is a search
Who is trained on what, what keeps recurring, where the evidence is, answered by digging.
Every gap is found by review
Someone holds the standard in one hand and the records in the other.
THE STAKES
The only way to get more hours has been to hire
FROM A SYSTEM OF RECORD TO A SYSTEM OF ACTION
Qualio does the routine work. You keep the decisions.
Qualio starts from your own records and standards. It does the drafting, the reading and the answering, shows the source behind every output, and routes each one to the person whose approval it needs.
Nothing enters your quality system without that signature, and the hours that went on drafting and reading go back to the decisions only your team can make.
What gets done
Clause-by-clause assessment
Assesses your records against every clause of every framework you run, so you know where you stand between audits.
Continuous reassessment
Reruns the assessment whenever a record changes, so a closed gap stays closed.
Gap recommendations
Puts a recommendation on every gap, so each one arrives with the fix proposed.
Evidence retrieval
Pulls the records behind any clause, so an auditor's question takes a search, not a week.
Quality event drafting
Raises a deviation or NCR from a description of what happened, and drafts the CAPA investigation.
Change control drafting
Prepares the change control from a revised procedure, so the reviewer reads instead of writes.
Training quizzes
Builds the quiz from the SOP, so a revision and its retraining go out together.
Training answers
Tells you who is trained on what, so the question stops being a report to build.
Trend spotting
Ask what keeps recurring, by product, supplier or root cause, and get the answer with the records cited.
Questionnaires and RFPs
Fills customer questionnaires from your controlled documents, so the answers are consistent and sourced.
Document review
Reviews or updates a controlled document on request, so the author starts from a marked-up draft.
Copilot chat
Ask about any procedure, requirement or clause and get a cited answer, in Qualio or from your own AI over MCP.
“Qualio gives us a clear picture of where we stand. It saves time on the initial work so we can focus on more strategic things.”
Allison IlesQuality Engineer, CogstateWhy the outputs hold up

MCP
Use Qualio from Claude, ChatGPT or your own agents

AI your auditor can inspect
Validated platform
A validation pack ships with every major release.
A full audit trail
Every action records its inputs, the clause applied, the evidence read and the person who approved it.
Your approval, every time
Nothing the AI drafts enters your quality system until someone on your team signs it off.
AI managed under ISO 42001
Qualio is certified to ISO 42001, the international standard for managing AI systems responsibly.
Works across everything Qualio can see
Qualio's AI works across all of Qualio: quality records, requirements, tests and risks, and the clauses of every framework you run. It reads from Jira, GitHub, SharePoint, Salesforce and the QMS you already run, and never writes back to them. So a finding goes from the clause to the evidence to a proposed fix with its source attached the whole way.
