The value of an audit lies in what happens to its findings. In Swat iQua Suite each observation recorded in an audit can raise its own CAPA. When the audit is approved, its CAPAs are approved in the same step, and from then on each one is tracked in CAPA Management through action verification, closure and, where needed, an effectiveness review.
Internal, external and supplier audits
- Internal audits — self-inspections of your own departments and sites.
- External audits — audits of your site by regulators, customers or other external parties.
- Partner (supplier) audits — audits of your suppliers, service providers and subcontractors.
Each type has its own reference numbering and its own CAPA source, so QA can report CAPAs from regulatory inspections separately from those raised in self-inspections or supplier audits.
Risk-based supplier audit frequency
Supplier audits connect to Supplier & Vendor Qualification, where site risk assessments give each supplier site a risk rating. That rating drives how often the supplier site should be audited, so a higher-risk supplier comes up for audit more often.
Visibility across the site
Audit due dates appear on the cross-module compliance calendar and in the daily overdue digest, so the audit programme is visible to the people who need to act on it. Every change to an audit record is written to the audit trail with its reason.