The operational stability and regulatory compliance of therapeutic goods manufacturers, biotechnology firms, and analytical testing laboratories depend heavily on the technical competency of their key personnel.
A strong quality culture is reflected in everyday behaviour. Staff understand their responsibilities, recognise potential quality risks, raise concerns appropriately, follow controlled processes, maintain reliable records and understand consequences
An electronic document management system (eDMS) provides a controlled environment for creating, reviewing, approving, distributing, revising and retaining documents and records.
Well-defined agreements provide the framework, while relevant and maintained training gives personnel the capability to operate within it.