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
Outsourcing quality assurance activities can provide pharmaceutical and biotechnology organisations with access to specialist knowledge, additional capacity and independent oversight.
Well-written procedures are fundamental to a controlled quality system. They translate organisational requirements into defined instructions that personnel can follow consistently and provide a documented basis for performing.
An electronic document management system (eDMS) provides a controlled environment for creating, reviewing, approving, distributing, revising and retaining documents and records.