Kinetic Gain · Trial Protocol Deviation Monitor
synthetic trial packets · capa queue
life sciences · deviation routing · quality evidence
Wave 17 · Insurance And Life Sciences Operations Protocol deviation routing proof Synthetic trial + packet exports

Protocol deviation evidence that stays operator-readable.

This control plane turns trial deviation data into one buyer-readable surface: missing source proof, retraining gaps, CAPA pressure, stale safety attachments, and the packets needed before inspection or quality trust slips.

OverviewProtocol LaneDeviation RoutingCAPA PostureVerificationDocs

CAPA Posture

packet readiness · blocker · cleanup window
58%
Clinical Quality

ONC-241 source reconciliation

Do not close the deviation until the signed source confirmation and retraining proof are bundled together.

  • Source confirmation still missing
  • 18 hours to the next deviation checkpoint
  • Status: RED
CAPA-14
91%
Site Operations

NEU-118 visit window packet

Packet is safe for sponsor QA confirmation and operator follow-up.

  • No active blocker
  • 42 hours to the next deviation checkpoint
  • Status: GREEN
CAPA-18
63%
Regulatory Affairs

IMM-330 CAPA bundle

CAPA can clear if safety evidence is repaired in the current review cycle.

  • Safety appendix proof is stale
  • 12 hours to the next deviation checkpoint
  • Status: YELLOW
CAPA-22
trial-protocol-deviation-monitor · synthetic sample data only
routes: / · /protocol-lane · /deviation-routing · /capa-posture · /verification · /docs