REGQUALITYREVIEW

Evidence for systems that carry regulated work.

Coverage desk

Complaints and Safety Reporting

Source-backed reporting and analysis connected to the companies, capabilities, authorities, and operating domains it affects.

Ennov RIM dashboards need conflict-preserving totals

Ennov describes dashboards and reporting across regulatory products, markets, registrations, submissions, correspondence, commitments, and timelines. Portfolio totals should preserve unresolved authority-state conflicts as their own counted population instead of silently selecting whichever local, central, or imported value arrived last.

A QT9 complaint closure needs a separate adverse-event reporting status

QT9 presents complaint handling with investigation, closure, escalation, and adverse-event reporting support inside its pharmaceutical QMS. Connecting those activities can reduce handoffs, but closing the quality complaint must not imply that a separate reporting assessment, submission, follow-up, or documented no-report decision is complete.