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Quality exceptions & release

CMP-26-10GxP hold active

Deviations, out-of-trend results, change controls and planning gaps across the active campaign. Records stay in Veeva Vault QMS and LabWare LIMS; this view reads them and links back.

Data as of 16:40 UTCDemo · read-only
Review QC-948Open Q-DEV-031
Frame QUAL-01

Open deviations

Observation

3

1 major · 2 minor

GxP release hold

ACTIVELot MES-26073

Campaign batches released

Calculated

2 of 3

66.7% · MES-26073 on hold

Out-of-trend results

Observation

1

QC-948 · review 1 of 2 complete

Exception queue

6 of 6 open items · sorted by severity, then age

RecordTypeSeverityOwnerAgeSystem of record
Q-DEV-031

BR-UP-01 feed droop −14.2% and PM-204 head-pressure exceedance (1.48 bar)

Root-cause investigation

DeviationMajor · Tier 2Priya Natarajan (QA)8 hVeeva Vault QMS
QC-948

Harvest titer 3.42 g/L vs alert limit >3.80 g/L

Second-person review pending

OOTOOT alertM. Okafor (QC)5 hLabWare LIMS

Label reconciliation discrepancy, harvest bags MES-26072 (2 of 48)

CAPA effectiveness check

DeviationMinor · Tier 3D. Kim (QA)4 dVeeva Vault QMS

CIP final-rinse conductivity alarm on UF-DF-02 (cleared on re-rinse)

Pending closure

DeviationMinor · Tier 3D. Kim (QA)7 dVeeva Vault QMS

PM-204 pump-head tubing part change (PharMed BPT → Pt-cured silicone)

Impact assessment

Change controlModerateR. Chen (Engineering)11 dVeeva Vault QMS
GAP-PLAN-06

PM-204 sanitization overlaps MES-26074 inoculation by 4.5 h

Two scenarios drafted, none applied

Planning gapSchedule riskMarcus Bell (Supervisor)1 dMaximo CMMS (PM) · MES plan

Severity and status are read from the system of record, not assigned by this app. Rows without a detail screen open a read-only summary in the inspector.

Active GxP holds

Lot → hold reasons → linked records. Release requires deviation closure and QA disposition in Veeva.

Observation

Lot

MES-26073QA hold since 2026-10-19 09:05 UTC
  • Hold reasonDeviation Q-DEV-031 open (Major · Tier 2)
  • Hold reasonOOT titer QC-948 · second-person review pending

Source sync

Systems of record remain authoritative

  • Veeva Vault QMS

    Read-only · synced 11 min ago

  • LabWare LIMS

    Read-only · synced 6 min ago

  • DeltaV eBR

    Read-only · synced 2 min ago

  • SAP ERP (batch disposition)

    Not connected · release status not verified against ERP

No writeback is configured. Drafts created here are handed off to QMS owners for entry.

Campaign release status

AB-mAb-014 (IgG1 Monoclonal Antibody)

Release status from Veeva QMS disposition. ERP not connected, so shipment status is unknown.

Next steps

Continue Q-DEV-031 investigation Second-person review · QC-948 Resolve GAP-PLAN-06