700+ life sciences companies

4.7/5 on

Where problems start

The work happens everywhere. The proof has to be in one place.

Engineering works in Jira, support in Zendesk, quality in the QMS. None of them can see the others.

The test that went stale

A requirement changed in Jira. The test that verifies it never ran again.

The training on last year's SOP

The SOP was revised in the QMS. The LMS still assigns the old version.

The complaint quality never saw

Closed as a support ticket in Zendesk, never assessed for reporting.

THE STAKES

The proof is the last place a problem shows up, and the audit is the worst place to find it

One place that sees across them

Connect once, and the proof builds itself in one place

Qualio reads from Jira, GitHub, Azure DevOps and your test tools, from SharePoint and Confluence, from Zendesk, Salesforce and HubSpot, and from MasterControl or Veeva where that is your QMS.

Every requirement, test result, complaint and procedure lands in one place as evidence, so Qualio sees across every tool when no one team can, and the ticket nobody closed shows up as a gap before the audit does.

The Results

80%

Less audit prep, a week became a day.

Sentec

-20h

20 hours a week back.

Simbiosys

50+

Audits a year, no added headcount.

eClinical

The requirements, code and test results your engineers already produce

Qualio reads requirements and user needs from Jira, Linear, Productboard, Asana and Azure DevOps, commits and releases from GitHub, issues from GitLab, and test cases and results from TestRail, Xray, Zephyr Scale and Azure Test Plans. From those it rebuilds the traceability automatically, across systems, and compiles the technical documentation from approved work.

Qualio requirement US-17 Patient Scan Annotation Limits linked to Jira, with open traceability issues and its user need

The documents, complaints and training records your teams already keep

Qualio reads controlled documents from OneDrive, SharePoint and Confluence, so document control runs on the editors your company already uses. It reads complaints and adverse events from Zendesk, Intercom, Salesforce, and HubSpot and raises them as quality events, with the customer interaction linked. The one place it writes is your LMS: when a document is approved, its details and a link go to ComplianceWire, so training points at the current version.

A Qualio training document open for editing, with the OneDrive file picker choosing a procedure from SharePoint

Every connected system feeds the compliance assessment, including the QMS you already run

Everything above becomes evidence for every standard you are audited against. Qualio also reads records directly from MasterControl and Veeva, so a company that is not moving its QMS can still assess it clause by clause, rerun whenever a record changes, and export the audit pack.

Explore all connectors

Qualio integrations catalog with connectors for OneDrive, Jira, Salesforce, TestRail, GitHub, Zendesk, Veeva Vault and MasterControl

Hear from our customers

Karen Hue
Head of Quality & GxP Compliance, 30 Technology

Eric Klumper
Chief Quality Officer, Black Fur Medical

Trend by batch, supplier and part

Every quality event names a batch, a supplier, a part or a piece of equipment. Typed as free text, nobody can trend or trace them. Qualio holds them as registers instead, fed from the systems that own them, so a CAPA links to the real supplier and trends appear by batch. Set up a register in an afternoon. Records arrive by integration, in the app or through the API.

Qualio deviation record SOP-106 with its procedure document fetched from OneDrive

MCP

Connect Claude, ChatGPT, or your own agents to Qualio

Any agent that speaks MCP can query documents, requirements, quality events, frameworks and gaps in Qualio, or raise an event and draft a change control, under that user's permissions and into the same audit trail. Native integrations bring the tools into Qualio. MCP brings Qualio into the tools.