The people side of GxP — qualifications, roles and history in one record.
Built by life science experts to simplify hr management.
“We always know — before an inspector asks — that the person on the line is qualified for the task.”
Improved traceability & automation
Replace manual coordination with structured, configurable workflows — with a full audit trail on every action.
Confident compliance
Designed to support FDA 21 CFR Part 11, EU GMP Annex 11 and ISO 13485 — inspection-ready by default.
Data-driven oversight
Monitor activity, backlogs and compliance KPIs in real time so leadership has the visibility it needs.
Faster implementation
Go live in weeks — not quarters — with structured rollout, training and 24/7 support.
From day one — every step controlled.
Qualification records
- Capture education, experience and certifications
- Verify and approve qualifications
- Alert on expiring certifications
- Maintain an inspector-ready CV per employee
Job-role matrix
- Define roles and the training required for each
- Assign roles to employees by site and department
- Drive LMS curriculum from role assignments
- Track role changes with full history
Authorisations
- Authorise people to perform specific GxP tasks
- Block execution when authorisation is missing or expired
- Re-authorise on a risk-based cadence
- Maintain a complete authorisation history
Onboarding & offboarding
- Drive onboarding training automatically
- Track completion before access is granted
- Revoke roles and access on exit
- Maintain a clean separation history
Everything HRM ships with.
Employee record
GxP-relevant data per person — no HRIS bloat.
Role library
Versioned role definitions with required training.
Authorisation engine
Granular task authorisations with expiry.
LMS integration
Drive curriculum from job-role assignments.
Inspector view
One-click qualification dossier per employee.
HRIS sync
Optional sync with Workday, SAP SuccessFactors and others.
Designed to support the standards you’re audited against.
See HRM on your own data.
Bring a real scenario from your operations — we’ll show you exactly how HR Management handles it.