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Quality Management

Every complaint and adverse event,
decided and closed

Complaints from Zendesk, Intercom, Salesforce or HubSpot become events in Qualio. Each carries the product and lot, the reportability decision and the CAPA it opened.

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The complaint reported to support reaches quality as an event

Qualio reads complaints from Zendesk, Intercom, Salesforce and HubSpot and raises each as an event on your complaint flow. The ticket comes with it. Support keeps the ticket. Quality gets the event, with the product, lot and version on it.

Quality events list with a CAPA, nonconformance, deviation, OOS result, complaint and audit finding in one workflow

Qualio keeps the reportability decision with the complaint, dated and signed

Reportability, to the FDA or under EU MDR vigilance, is a field on the complaint. The decision is made there. Who decided, what and when go into the audit trail, under an electronic signature.

Qualio change request with the description, reason for change and impact assessment of the affected documents

The CAPA opens from the complaint, with the investigation behind it

When the investigation calls for corrective action, you raise the CAPA from the complaint. The two stay linked, along with the supplier and the lot. Root cause, actions and the effectiveness check stay with the complaint that started them.

Effectiveness verification for CAPA-034, linked to the event that raised it and its corrective action, with no recurrences in 90 days

The notified body samples the procedure and the complaints it produced together

The PMS plan and the complaint handling procedure are controlled documents, approved and retrained on their effective date. The complaints, decisions and CAPAs they produced are linked to them, ready when the notified body or the FDA investigator samples the process.

Qualio change request with the description, reason for change and impact assessment of the affected documents

Platform connections

Integrations

Zendesk, Intercom, Salesforce, HubSpot and Microsoft Dynamics, read as they are. Qualio writes nothing back. See all integrations.

Regulated Product Lifecycle

Open events filter by product and link to the software version they concern, so the team changing that version sees what the field reported against it.

Compliance Frameworks

When a complaint closes or a procedure changes, Qualio reassesses the clauses it answers and recommends a fix for any gap.

Copilot

It drafts the complaint write-up and the CAPA investigation from the event, and answers what keeps recurring by product. Every output cites its source and waits for your approval.

Frequently Asked Questions

What is post-market surveillance?

Post-market surveillance is the work of collecting and acting on what happens to a product on the market: complaints, adverse events, service reports and published data. EU MDR and ISO 13485 require a plan and procedures for it. For medicines, the adverse event side of that work is pharmacovigilance.

Is the reportability decision signed under 21 CFR Part 11?

The decision is a field on the complaint event. The step that records it is signed electronically, with the signer’s name, the date and time and the meaning of the signature. Every later change is in the audit trail. A validation pack ships with every major release.

Do complaints logged in Zendesk or Intercom reach quality?

Yes. A ticket in Zendesk or Intercom is raised into a complaint event in Qualio with the ticket linked. Support closes its ticket. Quality decides the complaint.

How does Qualio handle a reportable complaint?

The reportability field records the decision, dated and signed, and the CAPA escalates from the complaint when the investigation needs one. The report itself, an eMDR under 21 CFR Part 803 or a serious incident report under EU MDR Article 87, is filed through the authority’s portal. Qualio holds the decision and the file you report from.

Does Qualio handle pharmacovigilance for medicines?

Complaints and adverse events for a medicine run as events with the batch on them. Each is investigated and signed, and the CAPA opens from it. That is the complaint file 21 CFR 211.198 asks for. Case reports to the authority still go through your pharmacovigilance system.

Which complaint is waiting on a reportability decision?

Bring one to the demo. We will log it as an event, record the decision and open the CAPA from it.

Part of Quality Management. See everything it does.

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