Clinical Development Hub
Local Demo
Home/capa

CAPA

Corrective/preventive action governance and evidence completion. 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.

CAPA Lifecycle Control

CAPA Open
2,000
Past Due
644
Verification Pending
451
CAPA Open
Past Due
Verification Pending

CAPA Evidence Completion

CAPA-2100 | STUDY-0001linked to KRI-00001 | owner Central Monitor
CAPA-2101 | STUDY-0002linked to KRI-00002 | owner Central Monitor
CAPA-2102 | STUDY-0003linked to KRI-00003 | owner Central Monitor
CAPA-2103 | STUDY-0004linked to KRI-00004 | owner CTM
CAPA-2104 | STUDY-0005linked to KRI-00005 | owner Safety Lead
CAPA-2105 | STUDY-0006linked to KRI-00006 | owner Central Monitor
CAPA-2106 | STUDY-0007linked to KRI-00007 | owner Safety Lead
CAPA-2107 | STUDY-0008linked to KRI-00008 | owner CTM
CAPA-2108 | STUDY-0009linked to KRI-00009 | owner Safety Lead
CAPA-2109 | STUDY-0010linked to KRI-00010 | owner Safety Lead
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.