Who it is for
If an inspector can close you down, this is built for you
The life sciences are where Masetra Systems started and where its depth lies. The same quality discipline applies across the adjacent regulated sectors below, wherever a national authority decides whether you keep trading.
Pharmaceuticals
Batch records, deviations and change control under national authority inspection, with registrations to maintain in every market you supply. The quality system is not paperwork here — it is the licence to operate.
Frameworks
WHO GMP
ISO 9001
21 CFR Part 11
ICH Guidelines
FDA GMP
National authority GMP guidelines
Where MasetraQMS helps today
Deviation and CAPA carry the daily load under GMP inspection, and risk management is where ICH Q9 expectations land. Change management keeps validated processes defensible.
Medical devices & diagnostics
Design controls, risk management and post-market surveillance, with device history records that have to reconcile against what was actually built and released.
Frameworks
ISO 13485
ISO 14971
ISO 9001
WHO GMP
21 CFR Part 11
ICH Guidelines
Where MasetraQMS helps today
Risk management is the centre of gravity here: ISO 14971 runs through design, production and post-market. Deviations and CAPAs feed it rather than sitting beside it.
Agro-chemicals & veterinary
Registration dossiers, batch release, and distribution controls across markets with distinct registration regimes and inspection expectations.
Frameworks
WHO GMP
ISO 9001
National registration requirements
Where MasetraQMS helps today
Batch release exceptions and registration-affecting changes are the two that cost you, and both are live modules. Risk assessment ties them to the markets they touch.
Regulatory coverage
The authorities that inspect you
These are the bodies whose expectations we build against. Regulatory knowledge is what the team brings, not a feature the platform claims to automate.
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
Not on this list?
The quality system underneath is the same wherever documented procedures, traceable records and corrective action are required. Tell us what you make and who inspects you, and we will say plainly whether MasetraQMS fits.
Ask us