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Smart Automated Solutions for Medical Device Top Management Teams

From oversight to Insight, bird’s-
eye view of operations, risks, and audit readiness — all in one place

With Regtech, Top Management doesn’t just review compliance, they control it in real time. From enterprise-wide dashboards to automated compliance alerts, our system ensures you have complete visibility, accountability, and foresight to lead your organization strategically.

Enterprise-Wide Compliance Dashboard

Stay on top of everything without drowning in details:

  • Live KPIs across Production, QC, QA, RA, and Stores
  • Track pending approvals, open CAPAs, and audit findings instantly
  • Visual health check of your QMS with indicators and notifications
One login. One screen. Total control.

Instant Audit & Inspection Readiness

Never scramble for audits again:

  • Auto-generated audit trails across departments
  • Auto-tracking of CAPAs, NCs, and audit findings
  • Drill down into site-wise or department-wise compliance data
  • Built-in reminders for certifications, renewals, and audits
Be inspection-ready anytime, not just during audit season.

Strategic Decision Support

Never scramble for audits again:

  • Production trends and batch performance insights
  • NC trends and recurring issues flagged for corrective action
  • Supplier performance linked with incoming QC
Turn compliance into a strategic advantage.

Automated Escalation Matrix

Don’t let critical issues slip through:

  • If CAPAs, Change Controls, or Approvals are delayed — Regtech auto-escalates to higher management
  • Ensures timely actions and accountability at all levels
  • Keeps compliance moving without manual follow-up
Turn compliance into a strategic advantage.

Multi-Site, Multi-User Oversight

Whether you manage one site or ten, Regtech grows with you:

  • Centralized QMS oversight across all locations
  • Compare site performance metrics side by side
  • Role-based access ensures you see exactly what you need — no clutter
Turn compliance into a strategic advantage.

Compliance Without Bottlenecks

  • Approvals can be completed from desktop or mobile — no more delays due to travel or absence
  • Every signature, comment, and decision logged — for accountability and transparency
  • Delegation options let you keep processes moving, even when leadership is unavailable
Turn compliance into a strategic advantage.

Centralized Management Reports

Generate the reports you need in seconds:

  • Monthly Management Review Reports (MRR) auto-compiled
  • CAPA Effectiveness Reports, Training Status, Calibration Overview — all one-click
  • Export to PDF, Excel, or share directly with auditors
Save hours of manual report prep. Focus on leadership, not paperwork.

With Regtech, Top Management shifts from firefighting to foresight — driving efficiency, compliance, and growth, all from one connected system.