Quality and Compliance

Know your open CAPAs—before the auditor asks

A manufacturer manages quality events, audits, and corrective actions across spreadsheets and email threads, so nobody has one current view of open nonconformances or overdue CAPAs until an external audit forces a scramble. Build the event-to-closure workflow as one system of record.

A QMS is a record, not a policy binder

Quality manuals describe how things should work. A QMS proves what actually happened: which events were logged, who investigated them, whether the fix worked, and where the evidence lives when someone asks.

Model the event, the investigation, and the corrective action as one connected record, so closure means something was actually verified—not just marked done.

From event to closure
  1. 1. Quality event or nonconformance is logged
  2. 2. Investigation records root cause and containment
  3. 3. CAPA is assigned with an owner and due date
  4. 4. Effectiveness is verified before the CAPA closes
  5. 5. Records are retained and reportable for audits
Who uses it

Three views of the same record

Investigator/owner

Assigned events and CAPAs, a place to document root cause, and evidence upload for containment and corrective action.

Approver

Review and approve corrective action plans, and confirm effectiveness checks before a CAPA can close.

Quality manager

An open-items dashboard, overdue CAPAs, and an audit-readiness view of the full evidence trail.

What the system tracks and automates

Records

Quality events, nonconformances, investigations, CAPAs, evidence and documents, audit trail.

Automations

Overdue-CAPA escalation, required-evidence reminders, and effectiveness-check scheduling.

Custom logic

Severity-based approval routing, and industry-specific record retention rules.

Platform

Own the application. P2HS runs the platform.

Example build brief

Example prompt
Build a quality management system with nonconformance logging, root cause investigation, CAPA assignment and tracking, effectiveness verification, and an audit-ready evidence trail.

Scenarios to test in your preview

  • A CAPA must not close without a recorded effectiveness check.
  • A nonconformance must retain its full investigation history even if reassigned to a new owner.
  • A rejected corrective action plan must return to the owner with the approver's reason attached.
FAQ

Common questions about QMS software

Who is this for?

Manufacturers and regulated businesses that need nonconformance, CAPA, and audit-evidence tracking in one connected system.

Does this replace ISO documentation?

No—it's the operational record of events and actions your quality system produces. Your documented procedures still define how the system should be used.

Related platform pages

See how a QMS fits into the wider P2HS platform.

Build the QMS that proves closure, not just claims it

Describe the workflow. Review the foundation. Launch it on your own domain.