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Solutions for Audits

From Evidence Gathering to Inspection Readiness — Simplified with Regtech

With Regtech, internal and external auditors gain a transparent, structured, and secure environment to perform compliance audits. The platform centralizes evidence, streamlines workflows, and ensures every audit trail is accessible, accurate, and inspection-ready.

Centralized Audit Planning

Organize audits without juggling Excel trackers.

  • Plan internal, supplier, and regulatory audits in one platform.
  • Assign auditors, define scope, and schedule with reminders.
  • Preloaded checklists for ISO 13485 inspection.
One platform to plan every audit - internal, supplier, or regulatory

Evidence Collection & Management

No more missing documents or last-minute chases.

  • Direct access to SOPs, records, CAPAs, and training logs.
  • Upload and tag evidence to audit findings.
  • Role-based permissions ensure secure yet traceable access.
No document chasing. No last-minute panic

Automated Audit Trails

Every action logged, every gap visible.

  • Full traceability of changes, approvals, and document history.
  • Timestamped, tamper-proof logs for regulatory defense
  • Easy navigation between audit observations and related records.
Every action traceable. Every decision defensible

Non-Conformance & CAPA Linkage

Turn audit findings into actionable improvements.

  • Record audit observations with severity levels.
  • Automatically link to CAPA workflows for closure.
  • Track status with dashboards until effectiveness is verified.
Audit findings that actually drive improvement

Real-Time Audit Dashboards

Instant visibility on compliance health.

  • Monitor audit progress, pending actions, and closure rates.
  • Heatmaps show recurring problem areas across departments.
  • Export audit reports in regulator-ready formats.
See audit status and risks at a glance

Inspection Readiness

Always ready for notified body, FDA, or customer audits.

  • Auto-generate internal audit reports.
  • Central archive for past audits and evidence.
  • One-click retrieval during live inspections.
Confident audits, even unannounced ones.

Centralized Regulatory Records

All approvals, dossiers, commitments, and letters:

  • Stored securely in one platform
  • Easily searchable with complete traceability

Be ready for any inspection — even the surprise ones. Role-based access control for RA leads, collaborators, and auditors.

Consistency from source to submission.

With Regtech, audits stop being a one-time pressure event — they become a continuous compliance advantage.