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Inspection Scenario Library
Browse all decision scenarios.
Use this index when you already know the decision type or want to inspect the broader scenario library.
Batch release or disposition
Who authorized this batch release, and what evidence did they review before making that decision? 21 CFR 211.188 · 21 CFR 211.192
View scenario → Who made the decision to reject this incoming material, and what was the regulatory basis for that determination? 21 CFR 211.84 · 21 CFR 211.122
View scenario → Who made the determination that the stability data supported extending the retest period, and what was the regulatory basis? 21 CFR 211.137 · ICH Q1A(R2)
View scenario → Deviation continuation or closure
CAPA closure or effectiveness
Who made the determination that this CAPA was effective, and what evidence supported that conclusion? 21 CFR 820.100
View scenario → Who made the decision that this was the root cause, and what evidence was used to reach that conclusion? 21 CFR 211.192 · 21 CFR 820.100
View scenario → Who made the determination that this complaint investigation was complete and that no further action was required? 21 CFR 211.198 · 21 CFR 820.198
View scenario → OOS investigation conclusion
Who made the final determination that this OOS result was assignable, and what was the basis? 21 CFR 211.192 · FDA OOS Guidance 2006
View scenario → Who made the determination that this stability data supported the claimed shelf life, and what was the basis? 21 CFR 211.166 · ICH Q1A(R2)
View scenario → Change control approval
Who made the regulatory impact determination for this change, and what was the basis for that assessment? 21 CFR 820.70 · EU Annex 11
View scenario → Who made the decision to accept this protocol deviation, and what was the scientific and regulatory basis? 21 CFR Part 11 · GAMP 5
View scenario → Who made the determination that this process was validated, and what evidence supported that conclusion? 21 CFR 211.68 · FDA Process Validation Guidance 2011
View scenario → Who made the determination that this system was validated for its intended use, and what was the regulatory basis? 21 CFR Part 11 · EU Annex 11 · GAMP 5
View scenario → Who made the determination that your cleaning validation data supported the claimed cleaning effectiveness? 21 CFR 211.67 · FDA Cleaning Validation Guidance
View scenario → Who made the determination that this specification change was scientifically justified and regulatorily acceptable? 21 CFR 211.160 · ICH Q6A
View scenario → Other consequential Quality decisions
Who made the qualification decision for this supplier, and what was the basis for that determination? 21 CFR Parts 210 and 211 · 21 CFR 211.84 · 21 CFR 820.50
View scenario → Who made the determination that this system remained in a state of control, and what evidence supported that conclusion? 21 CFR 211.180(e) · ICH Q10
View scenario → Who made the determination that this data integrity exception did not compromise the reliability of your records? 21 CFR Part 11 · FDA Data Integrity Guidance 2018
View scenario → Who made the determination that the risk level assigned was appropriate, and what evidence was used? ICH Q9 · 21 CFR 820.30
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