QT9 QMS

Open QT9 QMS, log an issue, and watch the follow-up write itself. From any browser, teams capture deviations, attach proof, and convert them into trackable actions without touching a spreadsheet. The workspace guides you to define scope, assign owners, and set due dates. Notifications keep assignees moving, while managers see status and bottlenecks in real time. Everything is centralized, searchable, and audit-ready.

When a nonconformance is recorded, convert it to a CAPA with a click. Outline containment, investigation, and permanent fix steps using built-in templates. Route tasks to engineering, production, or suppliers, and request evidence with required fields and attachments. Electronic approvals with 21 CFR Part 11-ready signatures create a tamper‑evident trail. If a change is needed, launch change control from the same record and link affected documents, lots, and equipment. Assign refresher training to impacted roles so process updates are adopted, not just approved.

Plan and execute audits the same way. Build an audit calendar, import checklists, and collect findings on site or remotely. Findings can spin off actions, risk assessments, or supplier follow-up, maintaining traceability end to end. Use the risk module to rank hazards, document mitigations, and monitor residual risk over time. Customer complaints are captured through a guided intake form, triaged, and connected to investigations, ensuring communication and closure tracked in one place. more