Preparing for an inspection usually means weeks of collecting printouts and spreadsheets from different departments. In Swat iQua Suite the evidence already exists as controlled records — batch records, QC results, deviations, CAPAs, audit trails — and the evidence framework knows which pieces are required for each decision. Inspection Readiness puts that framework to work for the inspection itself.
The evidence framework underneath
The same engine sits behind release and disposition decisions across the platform. Each evidence item has a state such as missing, pending, complete, failed, waived or not applicable. The system computes completeness and the number of critical gaps, and a server-side guard blocks a release while a critical gap exists — even an administrator cannot bypass it. Exceptions are approved by QA with segregation of duties and re-authentication, and they expire, so a waived item does not stay waived for ever.
Building an inspection dossier
- Create a dossier for the inspection; its evidence package and requested evidence requirements are created with it.
- Add scope while the dossier is in Draft.
- Review completeness and close the gaps the system shows.
- Approve with an e-signature; a SHA-256 checksum manifest is produced for the export.
The inspection type is recorded as descriptive text, so the same approach serves FDA, MHRA, EMA, CDSCO and WHO inspections from the same records. During the inspection, the audit trail report in Audit Trail & Data Integrity answers the follow-up questions, and open findings can be tracked in CAPA Management.
Inspection Readiness is one of the newer modules in Swat iQua Suite. The evidence framework beneath it is a mature platform engine; ask us in a demo to walk through a dossier for your site.