Audit-Ready Sign-Off: Validation Testing for Regulated SAP Systems

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Audit-ready validation card

• Scope: identify SOX key controls (application and ITGC) and GxP-relevant functions and records.
• Risk first: intended use → risk → assurance approach; document the rationale.
• High risk: scripted, positive and negative tests, independent review. Low risk: lighter, still recorded.
• Traceability: requirement → risk → spec → test → evidence → deviation → approval, with stable IDs.
• Evidence: who, when, what, result, approval. Follow ALCOA+.
• Never overwrite or back-date; record corrections with who, when and why.
• Approvals must post-date the evidence they approve.
• Cloud releases: assess, filter to scope, categorize, test before production, approve, archive.
• Leverage supplier information through a periodic supplier assessment.
• Rehearse audits: trace forward and backward; retrieve evidence in minutes.