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Copilot and agents

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.

Qualio Agents screen: four running agents, recent runs, and SCAR, CAPA and SOP drafts waiting for approval
VerantosTrivium VetAvectasiMixBiofidelity
4.7/5 on (667 reviews)

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.

The Results

50+

Audits a year, no added headcount.

eClinical

1 FTE

Hundreds of hours a year back.

xCures

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 IlesAllison IlesQuality Engineer, Cogstate
Case study

Why the outputs hold up

An AI is only as good as what it can see. Qualio's AI sees every clause of every framework you run and how the clauses relate to each other, and it sees your documents, templates, requirements, quality events and design controls in the same structure. So when it assesses a record it compares the actual clause with the actual evidence, and when it drafts a CAPA it starts from your procedure, your template and your history.

My actions list next to the Copilot answering a backup policy question with citations

MCP

Use Qualio from Claude, ChatGPT or your own agents

Connect any assistant that speaks MCP and ask it about your documents, requirements, quality events and gaps, or have it raise an event or draft a change control. It works under that user's permissions, and everything it does lands in the same audit trail.

Qualio consent screen asking the user to allow Claude to access their Qualio account

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.

ISO 13485 gap in Qualio, with Copilot drafting a change to SOP-59 that waits for QA approval
A gap against ISO 13485, with the Copilot draft of SOP-59 waiting for QA approval

Which work would you hand over first?

See Qualio's AI do the work, live.

667 reviews4.7/5