Home/ Platform/ Audit Management
Audit module — live

Plan, run and close internal and supplier audits without leaving a trail of spreadsheets.

Audit Management schedules internal self-inspections and supplier audits, gives auditors a structured checklist to capture findings on the spot, and pushes every finding directly into a tracked CAPA — instead of a report that gets filed and gradually forgotten.

21 CFR §211.22 21 CFR §211.84 ICH Q10
Back to platform overview
Regulatory basis

Self-inspection and supplier oversight are quality-unit obligations, not optional extras.

Audits are how a Quality Unit demonstrates it's checking its own system before a regulator does — the record has to hold up the same way any other GMP record does.

21 CFR §211.22

Quality Control Unit

Establishes the Quality Unit's responsibility and authority for approving or rejecting procedures and systems — the basis for a formal internal audit programme.

21 CFR §211.84

Testing and Approval of Components

Requires a documented basis for approving suppliers of components and materials — routinely evidenced through supplier audit findings and scorecards.

ICH Q10

Management Review & Monitoring

Expects periodic, systematic evaluation of the Pharmaceutical Quality System's performance — internal audit output is a primary input to that review.

EU GMP Chapter 9

Self-Inspection

Requires a structured self-inspection programme, findings recorded, and a corrective action plan implemented and monitored for effectiveness.

NOTE The module structures scheduling, checklists and finding capture. Auditor competence and finding judgment remain the responsibility of your assigned auditors.
Why teams use GxP Technology

An audit programme that produces action, not just a report.

The value of an audit isn't the report — it's what happens to the findings afterward. This module is built around that second half.

Reusable audit programmes

Build a checklist and schedule once per area or supplier, then reuse it — no rebuilding an audit plan from scratch every cycle.

Findings become CAPAs instantly

Log a finding on the spot and push it straight into a tracked CAPA — no re-keying between an audit tool and a separate CAPA system.

Supplier performance over time

Every supplier audit rolls into a scorecard, so a declining trend is visible before it becomes a supply disruption.

Export in inspection-ready form

Pull a complete, timestamped audit trail formatted the way a regulator expects to see it, in minutes rather than days.

See an audit go from finding to closed CAPA.

We'll walk through scheduling an audit, capturing a finding on a checklist, and watching it become a tracked CAPA in the same system.

hr@gxptechnology.com