Resources
Written for people who have to pass the inspection
Practical material on running a quality system in this region — not content marketing about digital transformation.
Library in preparation
Rather than pad this page with placeholder downloads, here is what we are writing first. If one of these would be useful to you now, say so and we will send it as soon as it is ready — or answer the question directly in the meantime.
Ask for one of theseGuide
How to adapt from paper to digital without losing your inspection
The process of transitioning to a digital quality management system while maintaining compliance.
Guide
Deviation to CAPA: a worked example
One deviation followed end to end, including the effectiveness check most systems skip.
Template
Deviation and CAPA template pack
Deviation handling, risk assessment and change control, formatted for revision.
Guide
Moving off paper without stopping production
Sequencing a QMS migration around a live manufacturing schedule.
Regulatory updates
Changes from the authorities in your markets
This feed will carry real changes from the bodies below, with effective dates and what they mean in practice. We are not publishing invented entries to fill it in the meantime.
Uganda
NDA
National Drug Authority
Kenya
PPB
Pharmacy and Poisons Board
Tanzania
TMDA
Tanzania Medicines and Medical Devices Authority
Rwanda
Rwanda FDA
Rwanda Food and Drugs Authority
Ethiopia
EFDA
Ethiopian Food and Drug Authority