Quality management systems · East Africa
Your quality system, off paper and ready for inspection
Transform regulatory compliance into competitive advantage with the only QMS platform designed specifically for East African life sciences companies.
Built in Uganda, for the authorities that actually inspect you.Who it is for
Life sciences first, and the sectors alongside them
Built for the life sciences first, where the quality system is the licence to operate. The same system serves the adjacent regulated sectors that answer to the same authorities.
The system
Four modules live, four in build
A deviation raises a CAPA, the deviation carries a risk assessment, and the change that follows is linked to the CAPA. One chain, one audit trail — across the four modules working today.
Available now
Deviation Management
Capture what went wrong, assess it, and close it out on the record.
Available now
CAPA Management
Corrective and preventive actions with real effectiveness checks.
Available now
Risk Management
Assess, rate and track risk so decisions can be justified later.
Available now
Change Management
Assess, approve and implement changes without losing the thread.
In build for phase two — included as they ship
Document Management
Training Management
Vendor Management
Audit Management
What we are building toward
Stated as targets
Masetra Systems is pre-launch and here is what the product is designed to achieve — we will publish the real figures once our first deployments produce them.
Target
90 days
From first deviation logged to a record set that stands up to inspection.
Target
One chain
Deviation to CAPA to risk to change, with nothing re-keyed between them.
Target
Phase two
Document, training, vendor and audit management, included as they ship.
Regulatory coverage
The authorities that inspect you
Global QMS vendors write for the FDA and the EMA. Masetra Systems is built where the National Drug Authority is the body at your door.
Uganda
National Drug Authority
NDA
Kenya
Pharmacy and Poisons Board
PPB
Tanzania
Tanzania Medicines and Medical Devices Authority
TMDA
Rwanda
Rwanda Food and Drugs Authority
Rwanda FDA
Ethiopia
Ethiopian Food and Drug Authority
EFDA