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Solution For Human Resource Teams

Competency Without Chaos, Training without gaps.

Regtech empowers HR teams to digitally manage employee lifecycle, training, and competency requirements while staying fully aligned with ISO 13485, FDA 21 CFR Part 820, and global regulatory expectations. From onboarding to ongoing training and role-based competency tracking Regtech ensures your workforce is always qualified, compliant, and inspection-ready

Role-Based Employee Master & Access Control

Every role. Clearly defined. Fully controlled.

  • Centralized employee master with role, department, and responsibility mapping
  • Auto-linked access rights based on designation and function
  • Prevents unauthorized system access or task execution
  • Instant visibility of active, inactive, and transferred employees
No more scattered folders. No more version confusion

Training Management System (TMS)

No more missed trainings or manual trackers.

  • Digitized training plans mapped to roles, SOPs, and regulatory requirements
  • Auto-assignment of mandatory trainings upon onboarding or role change
  • Training status dashboards: Pending, In-progress, Completed, Overdue
  • Electronic acknowledgment with date, time, and user authentication
Stay ahead of deadlines. Avoid surprises.

Competency and 
Qualification Tracking

Prove competence — not just attendance

  • Competency matrices linked to job roles and critical processes
  • Qualification status clearly visible for each employee
  • Skill gaps identified proactively before audits or inspections
  • Prevents assignment of tasks to unqualified personnel
Changes never slip past RA.

Audit-Ready Training & HR Records

Always ready — without last-minute scrambling.

  • One-click reports for training completion and competency status
  • Instant retrieval of employee qualification records during audits
  • Controlled storage of job descriptions, CVs, certificates, and records
  • Clear traceability for inspectors: Who is trained, on what, and when
  • Eliminates manual compilation of training evidence
Consistency from source to submission.

Integrated Deviation & CAPA Awareness

Training linked to quality events.

  • Identify training gaps arising from deviations or CAPAs

  • Auto-assign retraining based on investigation outcomes
  • Prevent recurrence through documented competency improvement
  • Auto-notifications when SOPs, policies, or work instructions are revised
  • HR becomes an active contributor to quality improvement
Your RA processes are synchronized across departments in one integrated system. No back-and-forth. Just connected, responsive workflows.

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.
Consistency from source to submission.

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.

A compliant system is only as strong as the people running it – Regtech ensures your HR processes build competence, confidence, and compliance.