Clinical Development Hub
Local Demo
Home/rbqm/actions evidence

Actions & Evidence

Investigation, action, CAPA, and evidence closure chain. 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.

Action-to-Evidence Chain

Actions
3,842
Evidence Linked
2,917
Sign-Off Pending
213
Actions
Evidence Linked
Sign-Off Pending

Evidence Sign-Off Queue

ACT-3200 | KRI-00001evidence pending sign-off | capa yes
ACT-3201 | KRI-00002evidence linked | capa draft
ACT-3202 | KRI-00003evidence linked | capa yes
ACT-3203 | KRI-00004evidence pending sign-off | capa draft
ACT-3204 | KRI-00005evidence linked | capa yes
ACT-3205 | KRI-00006evidence linked | capa draft
ACT-3206 | KRI-00007evidence pending sign-off | capa yes
ACT-3207 | KRI-00008evidence linked | capa draft
ACT-3208 | KRI-00009evidence linked | capa yes
ACT-3209 | KRI-00010evidence pending sign-off | capa draft
Access & Governance Controls
RBAC+ABACStudy Firewall Active

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.