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Solutions for Purchase Department

From Supplier Qualification to
Material Traceability — Purchase Made Compliant.

The Purchase department plays a pivotal role in ensuring that only approved, compliant, and traceable materials enter your medical device supply chain. With Regtech, you can streamline supplier management, automate approvals, trigger MSL-based purchase alerts, and maintain complete compliance records — all in one system.

Supplier Qualification & Approval

  • No more scattered supplier files or missing certificates.
  • Share digital Supplier Registration/Selection Forms directly with vendors via email.
  • Submitted forms are auto-integrated into the system, eliminating manual data entry.
  • Maintain a centralized supplier database with qualification status.
  • Upload and track supplier certifications (ISO 13485, CE, FDA, etc.).
  • Preloaded evaluation templates for supplier audits and risk assessments.
  • Automated reminders for certificate expirations and re-approvals
No more manual calculations. No more errors.

Automated Supplier Re-Evaluation

  • Supplier performance is continuously monitored.
  • Re-evaluation cycles auto-trigger based on pre-set frequency or compliance criteria.
  • Dashboards highlight on-time delivery, NCRs, CAPAs, and recurring non-conformances.
  • Risk-based classification (critical, major, minor) ensures high-risk suppliers are prioritized.
  • Add comments for revisions and send back to the supplier, ensuring a single version of truth.
Consistent QC outputs with no room for inspection errors

Purchase Order (PO) Compliance

  • Ensure every procurement is linked to compliance.
  • Generate and track purchase requests and POs with full traceability.
  • Restrict orders to only approved suppliers and materials.
  • Link suppliers, materials, and purchase records to QMS requirements.
  • Auto-flag high-risk or unapproved vendor purchases.
Regtech remember the dates, so you can focus on quality.

Material Traceability & MSL Monitoring

  • From supplier to final product — full visibility.
  • Map incoming materials directly to batch/lot numbers.
  • Seamless integration with Store and Production modules for real-time tracking
  • MSL-Based Purchase Notifications: system auto-flags the purchase team when stock falls below defined Minimum Stocking Levels (MSL), ensuring timely procurement and avoiding stockouts.
  • Digital records ensure traceability for recalls or PMS investigations.
Just connected, responsive processes

Supplier Communication & Evidence Sharing

  • Secure, audit-ready supplier engagement.
  • Share specifications, agreements, and compliance requirements digitally.
  • Receive supplier declarations, test reports, and certificates in one place.
  • Provide controlled access to external auditors/regulators for supplier-related evidence — without exposing your entire QMS.
No more manual calculations. No more errors.

Audit & Inspection Readiness

  • Be prepared for supplier-related scrutiny anytime.
  • One-click access to supplier qualification history and certificates.
  • Generate supplier compliance reports instantly.
  • Evidence retrieval tailored to specific audit needs.
No more manual calculations. No more errors.

Centralized Quality Records

All test results, calibration certificates, and inspection logs:

  • Stored securely in one platform
  • Accessible anytime, with complete traceability
Be ready for any audit — even the surprise ones
  • Role-based access control for inspection teams and auditors
No more manual calculations. No more errors.

With Regtech, your Purchase team doesn’t just buy materials, it automates supplier lifecycle management, safeguards traceability, and transforms procurement into a strategic driver of compliance and continuity.