Deviation Detail Record
Classification
2,000
Action Count
644
Closure State
451
Classification
Action Count
Closure State
Deviation Detail
Deviation detail with root cause, action plan, and evidence. This workspace exists to enforce consistent clinical execution with accountable ownership, governed evidence, and inspection-ready traceability across the study lifecycle. It supports business and regulatory requirements by connecting operations, quality, submissions, and financial controls in a single system where handoffs are explicit and auditable. Users can proceed by filtering scope, reviewing linked artifacts and actions, and routing escalations with defined approval gates and signature meaning.
Root Cause and Evidence
Record IDDEV-3509
ClassificationMajor process deviation with CAPA linkage
Root causeInconsistent visit preparation checklist execution
Corrective actionMandatory retraining + 100% source QC next 2 visits
Effectiveness checkScheduled 2026-04-05 by quality.local
Evidence packageTMF refs DOC-0004112, DOC-0004118
Access & Governance Controls
RBAC+ABACStudy Firewall ActiveRestricted Zone
Operational Controls
Study firewalling chips highlight boundary, country constraints, and vendor partition rules.
Actions requiring GxP control include a human review checkpoint and e-signature meaning capture.
Every state change writes immutable audit evidence with actor, timestamp, and object reference.
Next Actions
Filter to portfolio/program/study context.
Open linked tasks, risks, and document evidence.
Escalate blocked items through governed workflow.