GMP equipment maintained, calibrated and always audit-ready
In pharmaceuticals, every piece of equipment must be maintained and calibrated with a record that stands up to inspection. Mintema keeps every asset in a validated state and every action on the record.
Your journey, in six stops
From registering GMP equipment to the next regulatory inspection. Each stop shows the features you get.
- Stop 01RegisterEvery GMP asset with its critical data
- Stop 02CalibrateCalibration in date, every time
- Stop 03MaintainMaintenance under GMP control
- Stop 04MonitorCleanrooms and utilities watched around the clock
- Stop 05ProveA complete record for every inspection
- Stop 06ImproveFewer deviations, more uptime
Every GMP asset with its critical data
What you get- Site, area, room, equipment
Cleanrooms and labs where they really are.
- GMP fields, no code
Criticality, qualification status and owner.
- Controlled changes
Changes approved before they take effect.
Calibration in date, every time
What you get- Calibration plans
Intervals and tolerances per instrument.
- Results and certificates
As-found, as-left and certificates attached.
- Out of tolerance
Raises an impact assessment automatically.
Maintenance under GMP control
What you get- Planned maintenance
By date or usage, never overdue.
- QA approval
Work reviewed and signed before release.
- Electronic signatures
Every step signed with name and time.
Cleanrooms and utilities watched around the clock
What you get- Environmental readings
Pressure, temperature, humidity and particles.
- Rules on limits
Excursions raise alerts and deviations.
- Alerts by severity
With every acknowledgement recorded.
A complete record for every inspection
What you get- Full audit trail
Who did what, when and why.
- Access by role
Each user sees and signs only what they should.
- Inspection-ready reports
Equipment history in minutes.
Fewer deviations, more uptime
What you get- Compliance dashboards
Calibration, PM and deviations by area.
- Cost per asset
Labour, parts and vendors per equipment.
- Ask in plain language
Which instruments failed calibration this year?
Everything you gain, at a glance
- One GMP register
with critical data
- Calibration in date
every time
- Controlled maintenance
with QA sign-off
- Excursions caught
as they happen
- A complete record
for every inspection
- Fewer deviations
month after month
Use cases for pharma & life sciences
Each use case shows exactly how the platform is set up for that kind of asset.
Instruments, tolerances, certificates
Production line maintenanceLine, machine, motor, sensor
Safety & HSE inspectionsAudits, permits, findings, actions
Buildings & facility managementHVAC, lifts, fire, MEP
Medical equipment managementPPM, calibration, compliance
Data centresPower, cooling, uptime
Start with one area, grow across the site
A typical rollout. The scope and timing are agreed with you.
- Month 11
First area
GMP equipment of one area loaded.
- Asset import
- GMP fields
- Roles
- Months 2-32
Calibration and PM
Calibration plans, PM and QA approvals.
- Calibration
- PM plans
- Signatures
- Months 3-63
Monitoring
Environmental and utility readings with rules.
- Sensors
- Limits
- Alerts
- Ongoing4
Whole site
All areas with compliance dashboards.
- All areas
- Compliance KPIs
- Reports
Pharma & life sciences, answered
Have a question that is specific to your organisation? A solution engineer will answer it against your own assets, processes and data.
Yes. Approvals are signed with the user’s name, time and meaning.
Yes. Every change keeps who made it, when and why.
Yes. Rules can raise an impact assessment or deviation automatically.
Yes. Certificates and reports are attached to each calibration and job.
Your GMP equipment,
always audit-ready.
We will load a few of your instruments, run a calibration and show the full record behind it.