Resources are being prepared.
Sparko is preparing practical resources for CSV/CSA, GAMP 5, validation lifecycle, ISO 13485 QMS, CAPA and audit-readiness topics. This page will be promoted once enough useful content is published.
CSV/CSA readiness checklist
Planned resource for system owners and validation teams preparing GxP system validation evidence.
Validation file gap checklist
Planned resource for reviewing URS, risk assessment, traceability, test evidence and validation summary reports.
ISO 13485 audit-readiness checklist
Planned resource for checking QMS records, CAPA, supplier quality, document control and audit evidence.