Welcome to Quality Assist. 


We provide short-term top-up or specialist assistance to manufacturers of pharmaceuticals and medical devices.

We draw on a network of experienced partners and associates across South Africa. 

our services include:

QUALIty management systems


Setup: GMP, ISO 13495

Templates to save time

Lean rationalization

Auditing


Internal / pre-certification

Supplier risk ranking & evaluation

Mentoring of trainee auditors

Temporary cover - key personnel


Peak demand

Maternity leave 

Recruitment

Analytics


KPI dashboards

Quality objectives

Product / Management 

Reviews Investigations and CA


qualification


Rationalizing E.g. to ISPE Baseline Guide v2 2019 

Master plans, URSs, DQs, protocols, test plans

Clean rooms and utilities

Quality Risk Assessment: SME facilitation

validation


Critical Quality Attributes 

Critical Process Parameters

Sterilization

Process