Shaking Incubator – Traceability Matrix (URS ↔ Tests)


URS ID URS Statement Risk (H/M/L) DQ Test Ref IQ Test Ref OQ Test Ref PQ Test Ref Evidence/Record Result
URS-001 Shaking incubator must maintain temperature within specified range for optimal cell culture growth. H DQ-Ref-001 IQ-Ref-001 OQ-Ref-001 PQ-Ref-001 Temperature logs [Result]
URS-002 Shaking incubator must provide uniform shaking to ensure consistent cell culture conditions. M DQ-Ref-002 IQ-Ref-002 OQ-Ref-002 PQ-Ref-002 Shaking uniformity reports [Result]
URS-003 PLC logs must be available for monitoring and validation purposes. L DQ-Ref-003 IQ-Ref-003 OQ-Ref-003 PQ-Ref-003 PLC log records [Result]
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